Efficacy of daily and alternate-day dosing regimens with the combination buprenorphine naloxone tablet

Size: px
Start display at page:

Download "Efficacy of daily and alternate-day dosing regimens with the combination buprenorphine naloxone tablet"

Transcription

1 Drug and Alcohol Dependence 58 (2000) Efficacy of daily and alternate-day dosing regimens with the combination buprenorphine naloxone tablet Leslie Amass a, *, Jonathan B. Kamien b, Susan K. Mikulich a a Department of Psychiatry, Uni ersity of Colorado School of Medicine, Vine Street Center, 1741 Vine Street, Den er, CO 80206, USA b BioPsych Consulting, 360 Birch Street, Den er, CO 80220, USA Received 25 February 1999; received in revised form 1 July 1999; accepted 1 July 1999 Abstract This study evaluated the efficacy of a combination tablet formulation of buprenorphine containing 8 mg of buprenorphine and 2 mg of naloxone for every other day treatment and whether increasing the daily maintenance dose was essential for maintaining an efficacious alternate-day treatment. Twenty-six opioid-dependent outpatients completing a 16-day baseline entered a doubleblind, placebo-controlled, triple crossover trial. Twenty-one days of daily combination tablet administration were compared to two different 21-day periods of alternate-day buprenorphine administration where subjects received either 8 or 16 mg of the combination tablet every other day with placebo on the interposed day. Fifty-four percent (14/26) of subjects completed the study, but only two subjects dropped out during the 16-mg alternate-day condition. Rates of medication compliance, illicit opioid use and subject- and observer-rated measures of opioid effects did not distinguish daily from alternate-day treatments in subjects completing the study. However, pupillary diameter was significantly increased during 8-mg alternate-day compared to the 8-mg daily or 16-mg alternate-day treatment. These data replicate earlier findings describing the acceptability of alternate-day buprenorphine treatment using multiples of the daily maintenance dose and extend these findings by establishing the clinical efficacy of daily and alternate-day dosing regimens with the combination buprenorphine naloxone tablet. This study also suggests slightly improved outcomes during alternate-day treatment using multiples of the daily dose Elsevier Science Ireland Ltd. All rights reserved. Keywords: Alternate-day dosing; Buprenorphine; Buprenorphine naloxone; Heroin treatment; Human; Methadone treatment 1. Introduction * Corresponding author. Tel.: ; fax: address: (L. Amass) Buprenorphine is a high affinity, partial -opioid agonist pending FDA approval as a pharmacotherapy for opioid dependence (see Bickel and Amass, 1995). Buprenorphine s utility as a pharmacotherapy results from a unique profile of effects related to its partial agonist character and slow dissociation from -opioid receptors. Buprenorphine s ceiling on agonist activity decreases the danger of overdose, may limit its abuse liability (Walsh et al., 1994, 1995) and confers low toxicity even at high intravenous doses (Lange et al., 1990; Huestis et al., 1999), increasing the dose range over which it may be safely administered. Buprenorphine can also produce sufficient tolerance to block the effects of exogenously administered opioids (Bickel et al., 1988a; Rosen et al., 1994; Walsh et al., 1995), suggesting that it may help reduce illicit opioid use. Finally, buprenorphine s slow dissociation from -opioid receptors (Rance and Dickens, 1978) not only results in a long duration of action but also diminishes withdrawal signs and symptoms upon its discontinuation (Jasinski et al., 1978; Seow et al., 1986; Fudala et al., 1990; Amass et al., 1994b; Bickel et al., 1995, 1997; Cheskin et al., 1994), making it particularly useful for opioid detoxification. Controlled clinical evaluations confirm buprenorphine s utility for opioid dependence treatment. Studies comparing the relative efficacy of a sublingual buprenorphine solution to oral methadone have reported comparable retention and abstinence rates for up to 25 weeks of maintenance and detoxification treat /00/$ - see front matter 2000 Elsevier Science Ireland Ltd. All rights reserved. PII: S (99)

2 144 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) ment (Bickel et al., 1988b; Johnson et al., 1992; Strain et al., 1994). Additionally, buprenorphine is a safe, effective candidate for long term maintenance (Ling et al., 1996), compares favorably to other full-agonist alternatives such as levomethadyl acetate hydrochloride (LAAM; Chutuape et al., 1999), and produces significant and substantial improvements over time in psychosocial functioning (Strain et al., 1996). An important feature of buprenorphine is that, unlike methadone and like LAAM, it can be used safely on an alternate-day or thrice-weekly basis without the use of take-home medication. However, like methadone and unlike LAAM, buprenorphine can also be administered safely on a daily basis. Although alternate-day dosing regimens have been examined in several placebocontrolled studies with buprenorphine solution formulations, the most effective doses to use when administering buprenorphine on a less than daily basis have not yet been resolved (Fudala et al., 1990; Amass et al., 1994a, 1998; Johnson et al., 1995; Bickel et al., 1999). Some studies have given an 8-mg dose of buprenorphine every 48 h (Fudala et al., 1990; Johnson et al., 1995) while others have increased the dose to 16 mg when dosing every other day (Amass et al., 1994a, 1998; Bickel et al., 1999). Subjects receiving 8 mg of buprenorphine every other day have reported increased withdrawal scores relative to subjects receiving 8 mg every day (Fudala et al., 1990) and their treatment outcomes have tended to be slightly worse, even though these latter effects were not statistically significant (Johnson et al., 1995). Using multiples of the daily dose when administering buprenorphine every other day has resulted in minimal reports of withdrawal relative to daily dosing, an improved therapeutic profile (Amass et al., 1994a, 1998) and is preferred by subjects to daily dosing even when evaluated under open-label conditions (Amass et al., 1998). Multiplying the daily dose when dosing less than daily is feasible because the ceiling on buprenorphine s agonist activity renders high dose therapy safe and does not interfere with patient management (Amass et al., 1993; Walsh et al., 1994, 1995). Moreover, since plasma concentrations of buprenorphine and its metabolites increase proportionately as a function of dose following single dose administration (Walsh et al., 1994), multiplying the daily dose can also maintain buprenorphine blood levels that are comparable to those seen with daily dosing using a lower dose. Thus, while increasing the daily dose of buprenorphine appears to improve the clinical response to alternate-day dosing, finding optimal doses for alternate-day dosing awaits more research. Treatment with buprenorphine in the USA will employ a sublingual combination tablet containing buprenorphine and naloxone in a 4:1 ratio (Chiang and Hawks, 1994; Chiang et al., 1996a,b). Combination tablet dosages will be 8 mg of buprenorphine and 2 mg of naloxone, and 2 mg of buprenorphine and 0.5 mg of naloxone, respectively. The combination tablet was developed to help mitigate potential diversion and abuse of buprenorphine once it becomes available for widespread clinical use and is expected to be particularly useful sublingually because of the different parenteral to sublingual potencies of buprenorphine and naloxone. While buprenorphine has an approximately 2:1 parenteral to sublingual potency ratio (McQuay et al., 1986), studies with opioid-dependent subjects indicate a parenteral to sublingual potency ratio up to 20:1 for naloxone (Preston et al., 1990). A sublingual naloxone dose up to five times greater than the intravenous dose that reverses toxic opioid overdose can be administered safely to opioid abusers without precipitating withdrawal (Preston et al., 1990). Thus, this combination tablet may permit buprenorphine s agonist effects to be expressed when administered sublingually, in essence, permitting the combination tablet to behave like buprenorphine alone, while precipitating withdrawal if administered parenterally by opioid-dependent individuals. Less than daily dosing strategies have not been evaluated using the buprenorphine naloxone combination tablet and no studies have been published in which the two different alternate-day dosing strategies noted above have been directly compared to each other and to daily dosing. The purpose of the present study was to establish the clinical efficacy of alternate-day buprenorphine treatment using the combination buprenorphine naloxone tablet and determine whether using multiples of the daily dose during alternate-day dosing was essential for providing an efficacious alternate-day treatment. Daily dosing with the combination tablet was compared to alternate-day combination tablet dosing during which either the daily dose or a multiple of the daily dose was dispensed every other day. 2. Methods 2.1. Subjects Forty-seven opioid-dependent subjects (33 male, 14 female) participated in an 11-week outpatient study. Subjects were recruited through newspaper and poster advertisements and referred from local treatment programs. To be included in the study, subjects had to be at least 18 years old, in good health, and meet DSM-IV criteria for opioid dependence and FDA criteria for methadone treatment [i.e. a history of opioid dependence and either significant current opioid use (i.e. opioid-positive urines) or signs of opioid withdrawal (i.e. gooseflesh, sweating, lacrimation, excessive yawning, etc.)]. Eligibility was determined via a comprehen-

3 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) sive intake interview conducted in a 2 3-h session prior to admission. The interview included online administration of computerized versions of the psychoactive substance abuse disorder sections of the DSM-IV Criteria Checklist (modified from Hudziak et al., 1993) and the fifth edition of the Addiction Severity Index (McLellan et al., 1985). Additional questionnaires were also completed to provide information about demographics and drug history. Health status was determined by medical history, physical exam and laboratory evaluation (including complete blood count, clinical chemistry profiles and urinalyses). Exclusion criteria included evidence of active psychosis, manic-depressive illness, organic psychiatric disorders or serious medical (e.g. liver or cardiovascular disease) illness. Co-dependence on other drugs (e.g. cocaine, ethanol or sedative-hypnotics) did not exclude individuals from participation. The study was approved by the Colorado Multiple Institution Review Board for human research. Subjects provided written, informed consent after receiving a full explanation of the procedures prior to their inclusion in the study. Participants were required to pay a fee averaging $60/month to help support clinic services; no subjects were discharged due to non-payment of fees. Subjects mean age was 42.4 years (range 22 64). Subjects reported using opioids regularly for an average of 16.5 years (range 1 45) and spending $ (range $ ) per week on opioids. Thirty-eight subjects reported primarily intravenous, seven reported primarily intranasal and two reported primarily intramuscular opioid use. Forty subjects reported having received methadone treatment previously. Eleven subjects transferred from a methadone maintenance program directly into this study. Weekly pregnancy tests (urine hcg, Abbott Laboratories) for the 14 female subjects were negative throughout the study Buprenorphine induction and stabilization A 2-day, rapid induction procedure was used in accordance with published guidelines for transitioning patients onto buprenorphine (Bickel and Amass, 1995). On the first day of participation, the first 29 subjects enrolled in the study received two combination tablets that each contained 2 mg of buprenorphine and 0.5 mg naloxone, comprising a total dose of 4 mg of buprenorphine and 1 mg of naloxone. On the second day of participation, these subjects received one tablet containing 8 mg of buprenorphine and 2 mg of naloxone. Following complaints of withdrawal symptoms by seven (24%) of the 29 subjects on the second day of participation, the induction procedure was changed so that the next 18 subjects were induced with buprenorphine alone rather than the combination tablet. On the first day of participation, these latter 18 subjects received two tablets that each contained 2 mg of buprenorphine, comprising a total dose of 4 mg buprenorphine. On the second day of participation, these 18 subjects received one tablet containing 8 mg of buprenorphine. Only two (11%) of the 18 subjects inducted with buprenorphine alone complained of withdrawal symptoms on the second day of treatment. Following buprenorphine induction, subjects received one placebo tablet and one combination tablet containing 8 mg of buprenorphine and 2 mg of naloxone each day for the next 14 days (days 3 16) to establish a treatment baseline. The purpose of this baseline was (1) to stabilize subjects on a 24-h dosing schedule of the buprenorphine naloxone tablet and (2) to allow a period during which early treatment dropouts could be identified and culled from the final target study sample of at least 24 participants as determined by a prior power analysis. On day 2, subjects were told This is your maintenance dose by the dispensing nurse. On all subsequent days, subjects were not instructed regarding what doses they were receiving Medication administration Placebo, buprenorphine-alone and buprenorphine combination tablets were manufactured by Reckitt and Colman Products (Hull, UK) and supplied through the National Institute on Drug Abuse and Research Triangle Institute. Active tablets were flavored, white, flat and oval-shaped with a beveled edge; placebo tablets were matched in flavor, color, shape and size. Dosing conditions were double-blind and doses were masked for taste with a 1-ml sublingual flavor solution of Bitrex granules (6 g/ml; Macfarlan-Smith Ltd., Edinburgh, UK) and peppermint spirits (Amass et al., 1994a, 1998). Subjects swished the flavor solution in their mouth for 1 min and discarded it into a cup before receiving medication each day. The dispensing nurse gave the day s tablet(s) to the subject in a plastic cup and instructed the subject to hold the tablet(s) under the tongue until dissolved Study design Beginning on day 17, subjects received in randomized order each of three, 21-day dosing conditions: 8 mg/24 h,8mg/48 h and 16 mg/48 h. Subjects were instructed before the study that they would receive medication in each of three ways, but would not be told when dosing conditions changed. For 24-h dosing, subjects were told they would receive their daily dose each day. For 48-h single dosing, subjects were told they would receive their daily dose (i.e. a single dose) every other day with inactive placebo (blank) doses on the other days. For 48-h double dosing, subjects were told they would receive twice their daily dose (i.e. a double

4 146 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) dose) every other day with placebo (blank) doses on the other days. Every subject was scheduled to experience each of the three dosing schedules according to one of six possible sequences. Subjects were randomly assigned to one of these dosing schedule sequences, and the order in which the dosing schedules were received was balanced across subjects General procedures Subjects were compensated for their study participation according to a contingent compensation schedule designed to reinforce opioid abstinence and clinic attendance. Subjects received $2 for each opioid-negative sample provided and $2 each day they attended the clinic (defined as taking their scheduled dose of medication and completing any questionnaires). Further, if subjects provided three opioid-negative urine samples and attended all 7 days during any given treatment week, they received a bonus of $5. Thus, subjects could be compensated up to $25 per week and could earn a maximum of $275 for completing the 11-week study. Subjects who did not complete the study for any reason were offered detoxification with buprenorphine, transfer into the methadone or LAAM maintenance programs within our service, or referral to another local treatment facility. Buprenorphine detoxification was accomplished by decreasing the subject s buprenorphine dose by 2 mg a week until a zero dose was reached. Subjects were withdrawn from the study and offered alternative treatment if they failed to take their medication on three consecutive days and/or failed to provide urine samples on five consecutive occasions. Urine samples were collected thrice weekly (Mondays, Wednesdays and Fridays) before medication administration under observation and analyzed for the presence of opioids using the enzyme multiplied immunoassay technique (Behring Corporation, San Jose, CA). Samples were also analyzed for the presence of cocaine metabolites, amphetamines, benzodiazepines, barbiturates and cannabinoids on one randomly chosen day per week. Cutoff calibration concentrations of 300 ng/ml were used for tests of opioid and cocaine metabolites, 200 ng/ml for benzodiazepines and barbiturates, 50 ng/ml for cannabinoids and 1000 ng/ml for amphetamines. Missed urine samples were considered drug-positive for the purposes of data analysis. Breath alcohol samples were collected on urine testing days as part of routine clinical procedure and subjects were not permitted to attend the clinic intoxicated Counseling Subjects received individual, manualized behavioral counseling sessions (L. Amass, unpublished) with a trained therapist every other week for the duration of the study. Additionally, subjects could also participate in weekly group counseling sessions. Therapy sessions focussed primarily on helping subjects make lifestyle changes in the areas of their drug use, employment, family interactions, and social/recreational activities. Subjects also received AIDS education Subject- and obser er-rated measures Subject- and observer-rated measurements were collected every day prior to medication administration using a Macintosh Powerbook 520 computer (Apple Computer, Inc., Cupertino, CA) running custom-designed data acquisition software (BioPsych Consulting, Denver, CO). Subjects completed an adjective rating scale (Bickel et al., 1988a,b), six visual analog scales (VAS), the Addiction Research Center Inventory (ARCI) short form (Martin et al., 1971; Jasinski, 1977) and a dose identification questionnaire (Amass et al., 1994a, 1998). Subjects were instructed to respond to these questions according to their experience over the past 24 h. The adjective rating scale was comprised of 16 signs and symptoms of opioid withdrawal and 16 typical opioid agonist effects. Subjects rated themselves on a scale ranging from 0 (none) to 9 (severe) (maximum cumulative score=144). The items in the opioid withdrawal scale were muscle cramps, depressed or sad, painful joints, excessive yawning, hot or cold flashes, trouble getting to sleep, sick to stomach, irritable, runny nose, poor appetite, weak knees, excessive sneezing, tense and jittery, watery eyes, abdominal cramps and fitful sleep. The items in the opioid agonist effects scale were drug effect, loaded or high, rush, flushing, excessive sweating, nodding, dry mouth, turning of stomach, itchy skin, relaxed, coasting or spaced out, talkative, pleasant sickness, drive, nervousness and drunken. The VAS items were: How HIGH have you been?, Have you felt any DRUG EFFECT at all?, Have you felt any GOOD drug effects?, Have you felt any BAD drug effects?, Have you felt any WITHDRAWAL SICKNESS? and How much did you LIKE the drug effect?. Subjects positioned a cursor on the computer screen and clicked along a 100-unit line, anchored at each end by Not at all and Extremely. The ARCI short form consisted of 49 true/false items and contained five major subscales: MBG, PCAG, LSD, and BG and A, an index in opioid-abusing subjects of euphoria, sedation, dysphoria and stimulation, respectively. For the dose identification questionnaire, subjects responded to the question, What do you think you received for your medication yesterday? by choosing Placebo (no dose), Single dose of buprenorphine or Double dose of buprenorphine. Nursing staff blind to the treatment conditions completed an observer rating inventory on which they rated

5 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) the subjects on a scale of 0 (not at all) to 9 (severe) on seven signs of opioid withdrawal (tearing eyes, runny nose, perspiration, gooseflesh, yawning, restlessness, tremor; maximum cumulative score=63) and five signs of opioid effects (skin itching, vomiting, sedation, nodding, soap-boxing and rapping; maximum cumulative score=45). This observer-rating scale, based on Addiction Research Center agonist and withdrawal scales (Himmelsbach, 1939; Jasinski et al., 1978), has been used previously in similar studies of alternate-day dosing (Amass et al., 1994a, 1998; Bickel et al., 1999) Pupil measurements Pupil diameter was determined daily before medication administration. Photographs were taken of one of the subject s eyes with a Polaroid close-up camera at 2 magnification at 1 foot-candle of ambient illumination (Amass et al., 1994a; Bickel et al., 1999) Data analysis The study sample was classified into three groups for the purposes of data analyses: dropouts (n=21) were defined as those subjects who left treatment sometime during the 16-day baseline period; non-completers (n=12) were defined as those subjects who completed the baseline period but left the study at some point during exposure to the three 21-day treatment conditions; and completers (n=14) were defined as those subjects who completed the entire study. Analyses of variance (ANOVAs) were used to compare dropouts, non-completers and completers on selected intake measures (e.g. ASI composite scores, number of DSM-IV Substance Dependence or Abuse diagnoses, age and years of regular opioid use) to determine if any of these characteristics distinguished these groups from one another. Similarly, repeated measures ANOVAs were used to compare non-completers and completers on average baseline measures of subject- and observer-rated effects to determine if baseline responding could predict early treatment termination. Wilcoxon rank sum tests, appropriate for comparing two groups with non-normally distributed data, compared differences in the mean number of drug-positive urines obtained during baseline for the non-completer and completer groups. Finally, data from the 14 completers were used to compare the efficacy of the three 21-day treatment conditions. Each dependent variable was reduced to an average (e.g. self-reports, pupil diameter) or sum (e.g. positive/missed urines, medication compliance) across each treatment condition. Repeated measures ANOVA were then performed with the subject effect treated as random. Similar analyses were conducted to evaluate day-to-day fluctuations in the dependent variables within each treatment condition. These latter analyses were done to elucidate any potential differences between active drug and placebo days during alternateday dosing (or between odd and even days during daily dosing). Analyses were conducted using SAS (SAS Institute Inc., 1996) statistical software. All tests were two-tailed and statistical significance was specified at = Results 3.1. Buprenorphine induction Seven (24%) of the 29 subjects inducted with combination products complained of withdrawal symptoms sufficient to warrant notation by medical staff on the second day of participation. The symptoms consisted of prototypic signs of opioid withdrawal including sweating, runny nose, chills and vomiting. By comparison, only two (11%) of the 18 subjects inducted with buprenorphine alone products complained of withdrawal symptoms on the second day of treatment. Of the 29 subjects inducted with combination tablets, six subjects (21%) had transferred into the study from methadone-maintenance programs. The average methadone dose at the time of transfer onto buprenorphine was 50 mg (range 35 60). Of the seven subjects who had reactions following combination tablet induction, four (57%) were methadone-maintenance transfers receiving an average methadone maintenance dose of 48 mg (range 35 60) at the time of buprenorphine induction. Of the 18 subjects inducted with buprenorphine alone tablets, three subjects (17%) had transferred into the study from methadone-maintenance programs. The average methadone dose at the time of transfer onto buprenorphine was 39 mg (range 30 44). The two subjects who had reactions following induction with buprenorphine alone products were both illicit users of heroin and did not transfer into the study from a methadone-maintenance program Treatment retention and post-study status Forty-five percent of the subjects (21/47) dropped out during the treatment baseline. Six of these subjects dropped out following the first or second day, six did so following the fourth, sixth or seventh day and the remainder dropped out after 8 13 days. Eight of these subjects dropped out abruptly and did not provide a reason for leaving; two subjects left due to difficulty adjusting to the medication; two subjects left because their friend discontinued the study; one subject left due to administrative problems at the clinic; and two subjects left due to inability to commute to the clinic each

6 148 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) day. Four of these subjects later returned to participate in an efficacy evaluation of buprenorphine naloxone and methadone (Amass et al., 2000a); one transferred to methadone maintenance treatment at another facility; and one who had been in the present study for only a few days later returned to participate in another laboratory study at the center (Amass et al., 2000b). Fifty-five percent of the subjects (26/47) initiated at least one of the three treatment conditions. Of these 26 subjects, 54% (14/26) completed the study. Of the 12 subjects who did not complete the three treatment conditions (i.e. non-completers), five dropped out during the 8 mg/24 h condition, five dropped out during the 8 mg/48 h condition and two dropped out during the 16 mg/48 h condition. The condition under which the non-completer subjects left the study did not vary as a function of the order to which they were exposed to the treatment conditions. Of the 12 non-completers, four left treatment abruptly and did not provide a reason for leaving, seven later returned to participate in an efficacy evaluation of buprenorphine naloxone and methadone (Amass et al., 2000a), and one transferred to methadone maintenance treatment at another facility. Of the 14 completers, 12 subjects transferred directly into another an efficacy evaluation of buprenorphine naloxone and methadone (Amass et al., 2000a) and two requested detoxification with buprenorphine naloxone. One of these two subjects completed detoxification and continued on naltrexone; the other subject left treatment during the detoxification without providing a reason Intake differences amongst dropouts, completers and non-completers Subjects who dropped out of the study during the baseline condition had significantly higher Addiction Severity Index (ASI) Drug Problem composite scores than those who completed the study (t=2.53, P=0.01; data not shown). Dropout s ASI scores did not differ from those obtained from non-completers. No other significant differences were observed on intake variables among these three groups of subjects Baseline differences amongst completers and non-completers Completers differed significantly from non-completers on several baseline measures of self-reported drug effects as well as on the degree of illicit opioid use during baseline. Mean baseline subject-reported opioid withdrawal effect ratings (F=7.87, P=0.01), opioid agonist effect ratings (F=7.84, P=0.01), and visual analog scale ratings of bad drug effects (F=6.90, P=0.01), withdrawal sickness (F=7.90, P=0.01) and drug effect (F=4.57, P=0.04) were significantly lower in completers compared to non-completers (Fig. 1). Moreover, completers submitted significantly fewer opioid-positive urine samples than non-completers during the baseline (z=2.22, P=0.03; Fig. 2) Condition effects: treatment completer sample Medication compliance There were no differences in compliance across the three dosing conditions. Subjects were medicated on 86%, 84% and 88% of days during the 8 mg daily, 8 mg and 16 mg alternate-day conditions, respectively Illicit drug use The percentages of drug-positive urine samples obtained from subjects who completed the study are shown in Table 1. There were no significant differences in the number of drug-positive samples obtained across conditions Subject- and obser er-rated measures Subject- and observer-rated measures did not differ across the three treatment conditions. There were also no significant day-to-day fluctuations (i.e. odd versus even day differences) within each treatment condition on any of these measures Pupil diameter Average pupil diameter differed significantly across each 21-day treatment condition (F=4.02, P=0.03; Fig. 3). Mean pupil diameter was significantly larger during the 8 mg/48 h condition ( ) than it was during the 16 mg/48 h condition ( ; t= 2.79, P=0.01) and there was a trend toward larger pupil diameter during the 8 mg/48 h condition as compared to the 8 mg/24 h condition ( ; t= 1.82, P=0.08). There were no significant day-to-day fluctuations within each treatment condition in pupil diameter Dose identifications There were no significant differences across conditions in the percentage of time subjects identified the medication as a Single dose, a Double dose or a Placebo dose (data not shown). When data were collapsed across all three conditions, subjects identified their dose as a Single dose on 54% of occasions, as a Double dose on 10% of occasions and as a Placebo dose on 36% of occasions. The distribution of dose identifications within each treatment condition and across days (i.e. odd versus even) within each condition were similar.

7 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) Fig. 1. Mean scores obtained during baseline are shown for subject-rated opioid withdrawal (SRWD) and opioid agonist (SRAGO) effects (top) and the visual analog measures of bad, withdrawal sickness and drug effect (bottom) for the completer (shaded, n=14) and non-completer (white, n=12) patient samples. Maximum possible cumulative scale scores for subject-rated measures and maximum possible score for analog measures are shown on the y-axis. Vertical bars indicate +1 S.E.M. Asterisk denotes significant difference between completer and non-completer patient samples. 4. Discussion The combination buprenorphine naloxone tablet was as acceptable and effective when administered on alternate days as when administered every day. There were no reports of any significant opioid agonist or withdrawal effects by subjects or staff during the study, and rates of medication compliance and drug abstinence were roughly equivalent across daily and alternate-day conditions. These results compliment other placebo-controlled studies comparing daily versus alternate-day dosing using the 8 mg buprenorphine-only solution formulation (Fudala et al., 1990; Amass et al., 1994a, 1998; Johnson et al., 1995) and extend these earlier studies by establishing efficacy of alternate-day dosing with the combination buprenorphine naloxone tablet. Further, increasing the daily dose of buprenorphine may not be essential for use with alternate-day combination tablet dosing, although doing so may retain more patients in treatment when dosing every other day since fewer subjects dropped out during the present study s 16-mg (double-dose) alternate-day condition. Overall, alternate-day dosing studies support the notion that slightly better outcomes with alternate-day dosing are likely when higher doses are used (Fudala et al., 1990; Amass et al., 1994a, 1998; Johnson et al., 1995). The current study s results raise five important points. First, procedures for transitioning patients onto the combination tablet should be given careful consideration. Twice as many subjects inducted with the combi- Fig. 2. Mean percentage of opioid-positive urine samples obtained during baseline from the completer (shaded, n=14) and non-completer (white, n=12) patient samples are shown. Vertical bars indicate +1 S.E.M. Asterisk denotes significant difference between completer and non-completer patient samples.

8 150 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) Table 1 Percentage of urine samples positive for drugs of abuse a Drug screened 8mg/24 h 8mg/48 h Opioids Cocaine Amphetamines Cannabinoids Benzodiazepines Barbiturates a N=14, treatment completers. 16 mg/48 h Fig. 3. Mean pupillary diameter (mm) obtained during each 21-day exposure to the three dosing conditions from the 14 patients who completed the study. Vertical bars indicate +1 S.E.M. Asterisk denotes significant difference from 8 mg/24 h and 16 mg/48 h conditions. nation product in this study had reactions sufficient to cause clinical concern than did subjects inducted using buprenorphine only. Subjects experiencing these reactions were those transferring from methadone maintenance as well as street heroin users. While we cannot determine conclusively that the reactions observed during combination tablet induction were due solely to use of this product, circumventing even the potential of precipitating adverse reactions upon initiation of buprenorphine treatment will be important. Hence, our clinical experience recommends using buprenorphine only during the initial dose induction period. Comfort during buprenorphine dose induction will likely be critical to continuation of treatment by patients new to buprenorphine therapy. Second, a number of subjects in this study dropped out during the first 2 weeks of treatment or failed to complete the entire study. One possibility is that the fixed dose protocol led to some candidates not receiving an optimal clinical dose of the combination tablet. This theory is consistent with our observation of increased self-reports of adverse effects and greater illicit opioid use in the non-completer sample. Further, the bioavailability of tablet preparations of buprenorphine may be about 50 60% of the corresponding sublingual solution dose (Mendelson et al., 1996; Schuh and Johanson, 1999) and higher doses of the combination tablet may have reduced the number of drop outs in this study. Third, the results of the present alternate-day dosing evaluation differ from an earlier report with regard to obtained differences in self-report measures across daily and alternate-day dosing where sample sizes and study settings were similar. Pupil diameter was the only dependent measure that distinguished the three dosing conditions in the present study, whereas earlier work (Amass et al. 1998) revealed small but significant differences between daily and alternate-day dosing on several subject-rated measures of opioid effects as well as discriminations of active from inactive medication during alternate-day dosing. Similarly, our results differ from those reported in another placebo-controlled study in which subjects receiving 8 mg of the solution formulation of buprenorphine every other day on a residential research ward reported increased withdrawal scores relative to subjects receiving 8 mg every day (Fudala et al., 1990). However, a significant methodological difference between the present study and these earlier studies was the absence of mandated abstinence and compliance procedures. Those procedures were eliminated in the current study to permit comparison of the efficacy of the dosing schedules on standard measures such as drug use and treatment retention. Although compliance rates were good in the present study, over 50% of urine samples were positive for opiates across the dosing conditions. This supplemental opioid use likely obscured any potential differences in subject ratings across conditions that might have otherwise been observed. Although this rate of supplemental opioid use is not optimal, it is consistent with the pattern of drug use reported in other controlled trials of alternate-day buprenorphine treatment (Johnson et al., 1995), as well as controlled comparisons of buprenorphine to methadone (Strain et al., 1994; Ling et al., 1996). Fourth, the present study attests to the safety of using a combination product for alternate-day dosing when multiples of the daily maintenance dose are administered. Up to 4 mg of sublingual naloxone was administered every other day during the 16 mg/48 h dosing condition. No adverse reactions were observed in response to doubling a subject s maintenance dose in any of the subjects studied. This latter finding is consistent with laboratory studies of sublingual naloxone in opioid dependent subjects (Preston et al., 1990). Even higher levels of sublingual naloxone (i.e. up to 6 mg) are well tolerated with the combination tablet as suggested by studies with 3-day combination tablet dosing (Amass et al., 2000b).

9 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) Fifth, this study s limitations reduce the generality of the findings to most clinical settings. For example, a relatively small number of subjects were studied, the duration of treatment was short, a fixed dose protocol was used, and patients with active psychiatric comorbidity were excluded from participation. Certainly, the fixed dose protocol may have led to some candidates not receiving an optimal clinical dose of the combination tablet and may have affected early subject attrition. The high rate of study drop outs may have also reduced power to detect differences across treatments, although the crossover, counterbalanced design allowed each subject to serve as their own control. Studies that address these limitations are needed. Buprenorphine s use as both a daily and alternateday treatment has practical and therapeutic value. Alternate-day buprenorphine treatment is a clinically viable alternative to daily dosing that does not increase the risk of medication diversion typically associated with take-home agonist therapy (Goldman and Thistel, 1978; Kirn, 1988). Although the combination tablet was developed to allow take-home dosing while mitigating diversion, the abuse liability of the combination tablet awaits further study. There may still be occasions when patient instability may warrant withholding take-home medication for protective reasons. The combination tablet can also be used on a 3-day dosing schedule (e.g. Monday Wednesday Friday) and, like alternate-day dosing (Amass et al., 1998), this thrice-weekly dosing schedule is preferred by subjects to daily dosing (Amass et al., 2000b). When the use of take-home medication is not warranted, alternate-day dosing may also augment patient outcomes during buprenorphine therapy since reducing dosing frequency early in treatment increases retention in opioid dependent individuals (Rhoades et al., 1998). Finally, alternate-day (and thrice-weekly) dosing is a feature of buprenorphine that may promote its use in multiple settings, including primary care and office-based practices. Such use may facilitate expanding models of opioid maintenance therapy and help better address the ever growing problem of heroin addiction. Acknowledgements We thank the staff of the Vine Street Center, especially Dr Robert Willard, Margery Johnson and Janet Robinson, for medical services, Jason Thrun for excellent technical assistance, David Yeats and Butch Rodgers for counseling services, and Connie Miles, for medications preparation. Special thanks to Reckitt and Colman, Drs Richard Hawks and Nora Chiang of the Medications Development Division at the National Institute on Drug Abuse, and Dr George Bigelow for their helpful comments and support of this project. This project was supported by Grant DA11160 from the National Institute on Drug Abuse. Portions of these data were presented to the College on Problems of Drug Dependence, Inc., in Scottsdale, AZ, in June References Amass, L., Bickel, W.K., Higgins, S.T., Hughes, J.R., Peterson, T., Detectability of buprenorphine dose alterations in opioiddependent humans. In: Harris, L.S. (Ed.), Problems of Drug Dependence In: National Institute on Drug Abuse Research Monograph, vol US Government Printing Office, Washington, DC, p Amass, L., Bickel, W.K., Higgins, S.T., Badger, G.J., 1994a. Alternate-day dosing during buprenorphine treatment of opioid dependence. Life Sci. 54, Amass, L., Bickel, W.K., Higgins, S.T., Hughes, J.R., 1994b. A preliminary investigation of outcome following gradual or rapid buprenorphine detoxification. J. Addict. Dis. 13, Amass, L., Bickel, W.K., Crean, J.P., Blake, J., Higgins, S.T., Alternate-day buprenorphine dosing is preferred to daily dosing by opioid-dependent humans. Psychopharmacology 136, Amass, L., Kamien, J.B., Branstetter, S.A., Mikulich, S.K., 2000a. A controlled comparison of the buprenorphine naloxone tablet and methadone for opioid maintenance treatment: interim results. Presented to the 1999 Meeting of the College on Problems of Drug Dependence, Acapulco, Mexico, June. In: Harris, L.S. (Ed.), Problems of Drug Dependence, NIDA Research Monograph. US Government Printing Office, Washington DC (in press). Amass, L., Kamien, J.B., Mikulich, S.K. (2000b) Efficacy of and preference for 3-day vs. daily dosing with the buprenorphinenaloxone combination tablet in opioid dependent outpatients. Psychopharmacology (submitted for publication). Bickel, W.K., Amass, L., Buprenorphine treatment of opioid dependence: a review. Exp. Clin. Psychopharmacol. 3 (4), Bickel, W.K., Stitzer, M.L., Bigelow, G.E., Liebson, I.A., Jasinski, D.R., Johnson, R.E., 1988a. Buprenorphine: dose-related blockade of opioid challenge effects in opioid dependent humans. J. Pharmacol. Exp. Ther. 247, Bickel, W.K., Stitzer, M.L., Bigelow, G.E., Liebson, I.A., Jasinski, D.R., Johnson, R.E., 1988b. A clinical trial of buprenorphine: comparison with methadone in the detoxification of heroin addicts. Clin. Pharmacol. Ther. 43, Bickel, W.K., Amass, L., Higgins, S.T., Improving buprenorphine s outcomes with behavioral treatment. In: Harris, L.S. (Ed.), Problems of Drug Dependence. In: NIDA Research Monograph, vol US Government Printing Office, Washington, DC, pp Bickel, W.K., Amass, L., Higgins, S.T., Badger, G.J., Esch, R.A., Effects of adding behavioral treatment to opioid detoxification with buprenorphine. J. Consult. Clin. Psychol. 65 (5), Bickel, W.K., Amass, L., Crean, J.P., Badger, G.J., A doubleblind cross-over controlled trial of buprenorphine dosing every 72-hours in opioid-dependent humans: agonist and antagonist effects. Psychopharmacology (in press). Cheskin, L.J., Fudala, P.J., Johnson, R.E., A controlled comparison of buprenorphine and clonidine for acute detoxification from opioids. Drug Alcohol Depend. 36 (2), Chiang, C.N., Hawks, R., Development of a buprenorphine naloxone combination drug for the treatment of drug addiction.

10 152 L. Amass et al. / Drug and Alcohol Dependence 58 (2000) In: Harris, L.S. (Ed.), Problems of Drug Dependence. In: NIDA Research Monograph, vol US Government Printing Office, Washington, DC, p Chiang, C.N., Bridge, P., Creedon, K., Hawks, R.L., Herbert, S., Hill, J., Maghrablian, L., Terrill, J., Walsh, R., 1996a. Buprenorphine-naloxone combination product for treating opioid addiction [abstract]. Proceedings of the 58th Annual Scientific Meeting of the College on Problems of Drug Dependence, June, San Juan, Puerto Rico. Chiang, C.N., Bridge, P., Hawks, R.L., Herbert, S., Hill, J., Maghrablian, L., Terrill, J., Walsh, R., 1996b. The development of buprenorphine naloxone products for treating opiate dependence. In: Harris, L.S. (Ed.), Problems of Drug Dependence. In: NIDA Research Monograph, vol US Government Printing Office, Washington, DC, p Chutuape, M.A., Johnson, R.E., Strain, E.C., Walsh, S.L., Stitzer, M.L., Block, D.A., Bigelow, G.E., Controlled clinical trial comparing maintenance treatment efficacy of buprenorphine (bup), levomethadyl acetate (LAAM) and methadone (m). In: Harris, L.S. (Ed.), Problems of Drug Dependence. In: NIDA Research Monograph, vol US Government Printing Office, Washington, DC, p. 74. Fudala, P.J., Jaffe, J.H., Dax, E.M., Johnson, R.E., Use of buprenorphine in the treatment of opioid addiction. II. Physiologic and behavioral effects of daily and alternate-day administration and abrupt withdrawal. Clin. Pharmacol. Ther. 47, Goldman, F.R., Thistel, C.I., Diversion of methadone: illicit methadone use among applicants to two metropolitan drug abuse programs. Int. J. Addict. 13, Himmelsbach, C.K., Studies of certain addiction characteristics of (a) dihydromorphone. J. Pharmacol. Exp. Ther. 67, Hudziak, J., Helzer, J.E., Wetzel, M.W., Kessel, K.B., McGee, B., Janca, A., Przybeck, P., The use of the DSM-III-R checklist for initial diagnostic assessments. Compr. Psychiatry 34 (6), Huestis, M.A., Umbricht, A., Preston, K.L., Cone, E.J., Safety of buprenorphine: no clinically relevant cardiorespiratory depression at high IV doses. In: Harris, L.S. (Ed.), Problems of Drug Dependence. In: NIDA Research Monograph, vol US Government Printing Office, Washington, DC, p. 62. Jasinski, D.R., Assessment of the abuse potentiality of morphine like drugs (methods used in man). In: Martin, W.R. (Ed.), Drug Addiction I. Springer-Verlag, New York, pp Jasinski, D.R., Pevnick, J.S., Griffith, J.D., Human pharmacology and abuse potential of the analgesic buprenorphine. Arch. Gen. Psychiatry 35, Johnson, R.E., Jaffe, J.H., Fudala, P.J., A controlled trial of buprenorphine treatment for opioid dependence. J. Am. Med. Assoc. 267, Johnson, R.E., Eissenberg, T., Stitzer, M.L., Strain, E.C., Liebson, I.A., Bigelow, G.E., Buprenorphine treatment of opioid dependence: clinical trial of daily versus alternate-day dosing. Drug Alcohol Depend. 40, Kirn, T.F., Methadone maintenance treatment remains controversial even after 23 years of experience. J. Am. Med. Assoc. 260, Lange, W.R., Fudala, P.J., Dax, E.M., Johnson, R.E., Safety and side-effects of buprenorphine in the clinical management of heroin addiction. Drug Alcohol Depend. 26, Ling, W., Wesson, D.R., Charuvastra, C., Klett, C.J., A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence. Arch. Gen. Psychiatry 54, Martin, W., Sloan, J.W., Sapiro, J.D., Jasinski, D.R., Physiologic, subjective, and behavioral effects of amphetamine, metamphetamine, ephedrine, phenmetrazine and methylphenidate in man. Clin. Pharmacol. Ther. 12, McLellan, A.T., Luborsky, L., Cacciola, J., Griffith, J., Evans, F., Barr, H.L., O Brien, C.P., New data from the Addiction Severity Index: reliability and validity in three centers. J. Nerv. Ment. Dis. 173, McQuay, H.J., Moore, R.A., Bullingham, R.E.S., Buprenorphine kinetics. Adv. Pain Res. Ther. 8, Mendelson, J., Upton, R., Jones, R.T., Buprenorphine pharmacokinetics: bioavailability of an 8 mg sublingual tablet formulation. In: Harris, L.S. (Ed.), Problems of Drug Dependence. In: NIDA Research Monograph, vol US Government Printing Office, Washington, DC, p Preston, K.L., Bigelow, G.E., Liebson, I.A., Effects of sublingually given naloxone in opioid-dependent human volunteers. Drug Alcohol Depend. 25, Rance, M.J., Dickens, J.N., The influence of drug-receptor kinetics on the pharmacological and pharmaco-kinetic profiles of buprenorphine. In: Van Ree, J.M., Pereniums, L. (Eds.), Characteristics and Function of Opioids. Elsevier/North-Holland Biomedical Press, Amsterdam, pp Rhoades, H.M., Creson, D., Elk, R., Schmitz, J., Grabowski, J., Retention, HIV risk, and illicit drug use during treatment: methadone dose and visit frequency. Am. J. Public Health 88, Rosen, M.I., Wallace, E.A., McMahon, T.J., Pearsall, H.R., Woods, S.W., Price, L.H., Kosten, T.R., Buprenorphine: duration of blockade of effects of intramuscular hydromorphone. Drug Alcohol Depend. 35, SAS Institute, Inc., The MIXED Procedure, SAS/STAT Software Changes and Enhancements through Release SAS Institute Inc, Cary, NC, pp Schuh, K.J., Johanson, C.E., Pharmacokinetic comparison of the buprenorphine sublingual liquid and tablet. Drug Alcohol Depend. 56, Seow, S.S., Quigley, A.J., Ilett, K.F., Dusci, L.J., Swensen, G., Harrison-Stweart, A., Rappeport, L., Buprenorphine: a new maintenance opiate? Med. J. Aust. 144 (8), Strain, E.C., Stitzer, M.L., Liebson, I.A., Bigelow, G.E., Comparison of buprenorphine and methadone in the treatment of opioid dependence. Am. J. Psychiatry 151, Strain, E.C., Stitzer, M.L., Liebson, I.A., Bigelow, G.E., Buprenorphine versus methadone in the treatment of opioid dependence: self-reports, urinalysis, and Addiction Severity Index. J. Clin. Psychopharmacol. 16, Walsh, S.L., Preston, K.L., Stitzer, M.L., Cone, E.J., Bigelow, G.E., Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin. Pharmacol. Ther. 55, Walsh, S.L., Preston, K.L., Bigelow, G.E., Stitzer, M.L., Acute administration of buprenorphine in humans: partial agonist and blockade effects. J. Pharmacol. Exp. Ther. 274,

Treatment of Opioid Dependence with Buprenorphine/Naloxone (Suboxone )

Treatment of Opioid Dependence with Buprenorphine/Naloxone (Suboxone ) Treatment of Opioid Dependence with Buprenorphine/Naloxone (Suboxone ) Elinore F. McCance-Katz, M.D., Ph.D. Professor and Chair, Addiction Psychiatry Virginia Commonwealth University Neurobiology of Opiate

More information

Joanna L. Starrels. 2 ND YEAR RESEARCH ELECTIVE RESIDENT S JOURNAL Volume VIII, 2003-2004. A. Study Purpose and Rationale

Joanna L. Starrels. 2 ND YEAR RESEARCH ELECTIVE RESIDENT S JOURNAL Volume VIII, 2003-2004. A. Study Purpose and Rationale Outpatient Treatment of Opiate Dependence with Sublingual Buprenorphine/Naloxone versus Methadone Maintenance: a Randomized Trial of Alternative Treatments in Real Life Settings Joanna L. Starrels A. Study

More information

Prior Authorization Guideline

Prior Authorization Guideline Prior Authorization Guideline Guideline: CSD - Suboxone Therapeutic Class: Central Nervous System Agents Therapeutic Sub-Class: Analgesics and Antipyretics (Opiate Partial Agonists) Client: County of San

More information

One example: Chapman and Huygens, 1988, British Journal of Addiction

One example: Chapman and Huygens, 1988, British Journal of Addiction This is a fact in the treatment of alcohol and drug abuse: Patients who do well in treatment do well in any treatment and patients who do badly in treatment do badly in any treatment. One example: Chapman

More information

Treatment of Opioid Dependence: A Randomized Controlled Trial. Karen L. Sees, DO, Kevin L. Delucchi, PhD, Carmen Masson, PhD, Amy

Treatment of Opioid Dependence: A Randomized Controlled Trial. Karen L. Sees, DO, Kevin L. Delucchi, PhD, Carmen Masson, PhD, Amy Category: Heroin Title: Methadone Maintenance vs 180-Day psychosocially Enriched Detoxification for Treatment of Opioid Dependence: A Randomized Controlled Trial Authors: Karen L. Sees, DO, Kevin L. Delucchi,

More information

COMMUNITY BUPRENORPHINE PRESCRIBING IN OPIATE DEPENDENCE

COMMUNITY BUPRENORPHINE PRESCRIBING IN OPIATE DEPENDENCE COMMUNITY BUPRENORPHINE PRESCRIBING IN OPIATE DEPENDENCE INTRODUCTION High dose sublingual buprenorphine (Subutex) tablets are available in the following strengths 0.4 mg, 2 mg, and 8 mg. Suboxone tablets,

More information

AMERICAN ACADEMY OF ADDICTION PSYCHIATRY

AMERICAN ACADEMY OF ADDICTION PSYCHIATRY AMERICAN ACADEMY OF ADDICTION PSYCHIATRY BOARD OF DIRECTORS Michael H. Gendel, MD President Elinore F. McCance-Katz, MD, PhD President-Elect Joseph G. Liberto, MD Vice President Laurence M. Westreich,

More information

Update on Buprenorphine: Induction and Ongoing Care

Update on Buprenorphine: Induction and Ongoing Care Update on Buprenorphine: Induction and Ongoing Care Elizabeth F. Howell, M.D., DFAPA, FASAM Department of Psychiatry, University of Utah School of Medicine North Carolina Addiction Medicine Conference

More information

A HISTORICAL PERSPECTIVE ON HUMAN ABUSE LIABILITY STUDIES. Donald R Jasinski, MD

A HISTORICAL PERSPECTIVE ON HUMAN ABUSE LIABILITY STUDIES. Donald R Jasinski, MD A HISTORICAL PERSPECTIVE ON HUMAN ABUSE LIABILITY STUDIES Donald R Jasinski, MD Origin of methods Modify morphine molecule Develop a selective analgesic lacking abuse potential Reduce public health and

More information

Treatment of opioid use disorders

Treatment of opioid use disorders Treatment of opioid use disorders Gerardo Gonzalez, MD Associate Professor of Psychiatry Director, Division of Addiction Psychiatry Disclosures I have no financial conflicts to disclose I will review evidence

More information

Considerations in Medication Assisted Treatment of Opiate Dependence. Stephen A. Wyatt, D.O. Dept. of Psychiatry Middlesex Hospital Middletown, CT

Considerations in Medication Assisted Treatment of Opiate Dependence. Stephen A. Wyatt, D.O. Dept. of Psychiatry Middlesex Hospital Middletown, CT Considerations in Medication Assisted Treatment of Opiate Dependence Stephen A. Wyatt, D.O. Dept. of Psychiatry Middlesex Hospital Middletown, CT Disclosures Speaker Panels- None Grant recipient - SAMHSA

More information

Opioids Research to Practice

Opioids Research to Practice Opioids Research to Practice CRIT Program May 2011 Daniel P. Alford, MD, MPH Associate Professor of Medicine Boston University School of Medicine Boston Medical Center 32 yo female brought in after heroin

More information

Minimum Insurance Benefits for Patients with Opioid Use Disorder The Opioid Use Disorder Epidemic: The Evidence for Opioid Treatment:

Minimum Insurance Benefits for Patients with Opioid Use Disorder The Opioid Use Disorder Epidemic: The Evidence for Opioid Treatment: Minimum Insurance Benefits for Patients with Opioid Use Disorder By David Kan, MD and Tauheed Zaman, MD Adopted by the California Society of Addiction Medicine Committee on Opioids and the California Society

More information

Heroin. How Is Heroin Abused? How Does Heroin Affect the Brain? What Other Adverse Effects Does Heroin Have on Health?

Heroin. How Is Heroin Abused? How Does Heroin Affect the Brain? What Other Adverse Effects Does Heroin Have on Health? Heroin Heroin is an opiate drug that is synthesized from morphine, a naturally occurring substance extracted from the seed pod of the Asian opium poppy plant. Heroin usually appears as a white or brown

More information

Integrating Medication- Assisted Treatment (MAT) for Opioid Use Disorders into Behavioral and Physical Healthcare Settings

Integrating Medication- Assisted Treatment (MAT) for Opioid Use Disorders into Behavioral and Physical Healthcare Settings Integrating Medication- Assisted Treatment (MAT) for Opioid Use Disorders into Behavioral and Physical Healthcare Settings All-Ohio Conference 3/27/2015 Christina M. Delos Reyes, MD Medical Consultant,

More information

Buprenorphine dosing regime in the management of out-patient heroin withdrawal

Buprenorphine dosing regime in the management of out-patient heroin withdrawal Drug and Alcohol Review (2002) 21, 39 45 Buprenorphine dosing regime in the management of out-patient heroin withdrawal NICHOLAS LINTZERIS Turning Point Alcohol and Drug Centre and Australian National

More information

Program Assistance Letter

Program Assistance Letter Program Assistance Letter DOCUMENT NUMBER: 2004-01 DATE: December 5, 2003 DOCUMENT TITLE: Use of Buprenorphine in Health Center Substance Abuse Treatment Programs TO: All Bureau of Primary Health Care

More information

Care Management Council submission date: August 2013. Contact Information

Care Management Council submission date: August 2013. Contact Information Clinical Practice Approval Form Clinical Practice Title: Acute use of Buprenorphine for the Treatment of Opioid Dependence and Detoxification Type of Review: New Clinical Practice Revisions of Existing

More information

Using Buprenorphine in an Opioid Treatment Program

Using Buprenorphine in an Opioid Treatment Program Using Buprenorphine in an Opioid Treatment Program Thomas E. Freese, PhD Director of Training, UCLA Integrated Substance Abuse Programs Director, Pacific Southwest Addiction Technology Transfer Center

More information

Heroin. How Is Heroin Abused? How Does Heroin Affect the Brain? What Other Adverse Effects Does Heroin Have on Health?

Heroin. How Is Heroin Abused? How Does Heroin Affect the Brain? What Other Adverse Effects Does Heroin Have on Health? Heroin Heroin is an opiate drug that is synthesized from morphine, a naturally occurring substance extracted from the seed pod of the Asian opium poppy plant. Heroin usually appears as a white or brown

More information

Cessation of methadone maintenance treatment using buprenorphine: transfer from methadone to buprenorphine and subsequent buprenorphine reductions

Cessation of methadone maintenance treatment using buprenorphine: transfer from methadone to buprenorphine and subsequent buprenorphine reductions Drug and Alcohol Dependence 71 (2003) 49/55 www.elsevier.com/locate/drugalcdep Cessation of methadone maintenance treatment using buprenorphine: transfer from methadone to buprenorphine and subsequent

More information

CONTINGENCY MANAGEMENT AND ANTISOCIAL PERSONALITY DISORDER

CONTINGENCY MANAGEMENT AND ANTISOCIAL PERSONALITY DISORDER CONTINGENCY MANAGEMENT AND ANTISOCIAL PERSONALITY DISORDER Karen K. Chan 1,3, Alice Huber 1,2,3, John M. Roll 1,3, and Vikas Gulati 1,3 Friends Research Institute, Inc. 1 Long Beach Research Foundation:

More information

Office-based Treatment of Opioid Dependence with Buprenorphine

Office-based Treatment of Opioid Dependence with Buprenorphine Office-based Treatment of Opioid Dependence with Buprenorphine David A. Fiellin, M.D Professor of Medicine, Investigative Medicine and Public Health Yale University School of Medicine Dr. Fiellin s Disclosures

More information

New York State Office of Alcoholism & Substance Abuse Services Addiction Services for Prevention, Treatment, Recovery

New York State Office of Alcoholism & Substance Abuse Services Addiction Services for Prevention, Treatment, Recovery New York State Office of Alcoholism & Substance Abuse Services Addiction Services for Prevention, Treatment, Recovery USING THE 48 HOUR OBSERVATION BED USING THE 48 HOUR OBSERVATION BED Detoxification

More information

Medication-Assisted Treatment (MAT) & What It Means Long-Term Gary K. Byrd., M.Ed., MAC, CCS, CAMS Methadone is the Gold Standard for treatment of chronic heroin addiction Gary Byrd 2015 1 Gary Byrd 2015

More information

Heroin. How is Heroin Abused? What Other Adverse Effects Does Heroin Have on Health? How Does Heroin Affect the Brain?

Heroin. How is Heroin Abused? What Other Adverse Effects Does Heroin Have on Health? How Does Heroin Affect the Brain? Heroin Heroin is a synthetic opiate drug that is highly addictive. It is made from morphine, a naturally occurring substance extracted from the seed pod of the Asian opium poppy plant. Heroin usually appears

More information

BUPRENORPHINE THERAPIES FOR THE TREATMENT OF OPIOID DEPENDENCE - SUBUTEX AND SUBOXONE*

BUPRENORPHINE THERAPIES FOR THE TREATMENT OF OPIOID DEPENDENCE - SUBUTEX AND SUBOXONE* BUPRENORPHINE THERAPIES FOR THE TREATMENT OF OPIOID DEPENDENCE - SUBUTEX AND SUBOXONE* Chris B Chapleo Director of Buprenorphine Business Reckitt Benckiser Healthcare (UK) Limited Introduction Drug addiction

More information

Depot Naltrexone Appears Safe and Effective for Heroin Addiction

Depot Naltrexone Appears Safe and Effective for Heroin Addiction of 2 http://www.drugabuse.gov/nida_notes/nnvol21n3/depot.html 10/20/2011 11:23 AM NIDA NEWS NIDA Home > Publications > NIDA Notes > Vol. 21, No. 3 > Research Findings Depot Naltrexone Appears Safe and

More information

Use of Buprenorphine in the Treatment of Opioid Addiction

Use of Buprenorphine in the Treatment of Opioid Addiction Use of Buprenorphine in the Treatment of Opioid Addiction Multiple Choice Identify the choice that best completes the statement or answers the question. 1. Executive Summary Which of the following is an

More information

Methadone. Buprenorphine 10/9/2015

Methadone. Buprenorphine 10/9/2015 Medication Assisted Treatment for Opioid Addiction Tanya Hiser, MS, LPC Premier Care of Wisconsin, LLC October 21, 2015 How Did We Get Here? Civil War veterans and women 19th Century physicians cautious

More information

Opioids Research to Practice

Opioids Research to Practice Opioids Research to Practice CRIT/FIT 2015 May 2015 Daniel P. Alford, MD, MPH, FACP, FASAM Associate Professor of Medicine Assistant Dean, Continuing Medical Education Director, Clinical Addiction Research

More information

Prior Authorization Guideline

Prior Authorization Guideline Prior Authorization Guideline Guideline: PDP IBT Inj - Vivitrol Therapeutic Class: Central Nervous System Agents Therapeutic Sub-Class: Opiate Antagonist Client: 2007 PDP IBT Inj Approval Date: 2/20/2007

More information

In 2010, approximately 8 million Americans 18 years and older were dependent on alcohol.

In 2010, approximately 8 million Americans 18 years and older were dependent on alcohol. Vivitrol Pilot Study: SEMCA/Treatment Providers Collaborative Efforts with the treatment of Opioid Dependent Clients Hakeem Lumumba, PhD, CAADC SEMCA Scott Schadel, MSW, LMSW, CAADC HEGIRA PROGRAMS, INC.

More information

Substitution Therapy for Opioid Dependence The Role of Suboxone. Mandy Manak, MD, ABAM, CCSAM Methadone 101-Hospitalist Workshop, October 3, 2015

Substitution Therapy for Opioid Dependence The Role of Suboxone. Mandy Manak, MD, ABAM, CCSAM Methadone 101-Hospitalist Workshop, October 3, 2015 Substitution Therapy for Opioid Dependence The Role of Suboxone Mandy Manak, MD, ABAM, CCSAM Methadone 101-Hospitalist Workshop, October 3, 2015 Objectives Recognize the options available in treating opioid

More information

Treatment of Prescription Opioid Dependence

Treatment of Prescription Opioid Dependence Treatment of Prescription Opioid Dependence Roger D. Weiss, MD Chief, Division of Alcohol and Drug Abuse McLean Hospital, Belmont, MA Professor of Psychiatry, Harvard Medical School, Boston, MA Prescription

More information

MEDICALLY SUPERVISED OPIATE WITHDRAWAL FOR THE DEPENDENT PATIENT. An Outpatient Model

MEDICALLY SUPERVISED OPIATE WITHDRAWAL FOR THE DEPENDENT PATIENT. An Outpatient Model MEDICALLY SUPERVISED OPIATE WITHDRAWAL FOR THE DEPENDENT PATIENT An Outpatient Model OBJECTIVE TO PRESENT A PROTOCOL FOR THE EVALUATION AND TREATMENT OF PATIENTS WHO ARE CHEMICALLY DEPENDENT ON OR SEVERLY

More information

A dose effect study of repeated administration of buprenorphine/naloxone on performance in opioid-dependent volunteers

A dose effect study of repeated administration of buprenorphine/naloxone on performance in opioid-dependent volunteers Drug and Alcohol Dependence 74 (2004) 205 209 Short communication A dose effect study of repeated administration of buprenorphine/naloxone on performance in opioid-dependent volunteers Miriam Z. Mintzer

More information

State Issue Brief on the Use of Buprenorphine and Implications for State AOD Systems

State Issue Brief on the Use of Buprenorphine and Implications for State AOD Systems National Association of State Alcohol and Drug Abuse Directors, Inc. State Issue Brief State Issue Brief on the Use of Buprenorphine and Implications for State AOD Systems INTRODUCTION This State Issue

More information

Buprenorphine: blending practice and research

Buprenorphine: blending practice and research Journal of Substance Abuse Treatment 23 (2002) 87 92 Regular article Buprenorphine: blending practice and research Walter Ling, M.D. a, *, David Smith, M.D. b a Integrated Substance Abuse Programs, University

More information

BUPRENORPHINE TREATMENT: A TRAINING FOR MULTIDISCIPLINARY ADDICTION PROFESSIONALS

BUPRENORPHINE TREATMENT: A TRAINING FOR MULTIDISCIPLINARY ADDICTION PROFESSIONALS BUPRENORPHINE TREATMENT: A TRAINING FOR MULTIDISCIPLINARY ADDICTION PROFESSIONALS NIDA/SAMHSA Blending Initiative According to the Webster Dictionary definition To Blend means: a. combine into an integrated

More information

KAP Keys. For Physicians. Based on TIP 40 Clinical Guidelines for the Use of Buprenorphine in the Treatment. of Opioid Addiction

KAP Keys. For Physicians. Based on TIP 40 Clinical Guidelines for the Use of Buprenorphine in the Treatment. of Opioid Addiction Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction Knowledge Application Program KAP Keys For Physicians Based on TIP 40 Clinical Guidelines for the Use of Buprenorphine

More information

The feasibility of abrupt methadone-buprenorphine transfer in British opiate addicts in an outpatient setting

The feasibility of abrupt methadone-buprenorphine transfer in British opiate addicts in an outpatient setting The feasibility of abrupt methadone-buprenorphine transfer in British opiate addicts in an outpatient setting F. D. LAW, J. E. BAILEY, D. S. ALLEN, J. K. MELICHAR, J. S. MYLES, 1 M. C. MITCHESON, 1 J.

More information

Update and Review of Medication Assisted Treatments

Update and Review of Medication Assisted Treatments Update and Review of Medication Assisted Treatments for Opiate and Alcohol Use Disorders Richard N. Whitney, MD Medical Director Addiction Services Shepherd Hill Newark, Ohio Medication Assisted Treatment

More information

Death in the Suburbs: How Prescription Painkillers and Heroin Have Changed Treatment and Recovery

Death in the Suburbs: How Prescription Painkillers and Heroin Have Changed Treatment and Recovery Death in the Suburbs: How Prescription Painkillers and Heroin Have Changed Treatment and Recovery Marvin D. Seppala, MD Chief Medical Officer Hazelden Betty Ford Foundation This product is supported by

More information

Sublingual buprenorphine/naloxone precipitated withdrawal in subjects maintained on 100 mg of daily methadone

Sublingual buprenorphine/naloxone precipitated withdrawal in subjects maintained on 100 mg of daily methadone Drug and Alcohol Dependence 90 (2007) 261 269 Sublingual buprenorphine/naloxone precipitated withdrawal in subjects maintained on 100 mg of daily methadone James Rosado a,b, Sharon L. Walsh a,c, George

More information

Like cocaine, heroin is a drug that is illegal in some areas of the world. Heroin is highly addictive.

Like cocaine, heroin is a drug that is illegal in some areas of the world. Heroin is highly addictive. Heroin Introduction Heroin is a powerful drug that affects the brain. People who use it can form a strong addiction. Addiction is when a drug user can t stop taking a drug, even when he or she wants to.

More information

Dosing Guide. For Optimal Management of Opioid Dependence

Dosing Guide. For Optimal Management of Opioid Dependence Dosing Guide For Optimal Management of Opioid Dependence KEY POINTS The goal of induction is to safely suppress opioid withdrawal as rapidly as possible with adequate doses of Suboxone (buprenorphine HCl/naloxone

More information

Treatment of Heroin Dependence

Treatment of Heroin Dependence Reprinted from the German Journal of Psychiatry http://www.gjpsy.uni-goettingen.de ISSN 1433-1055 Treatment of Heroin Dependence Jamshid Ahmadi, Hassan Farrashbandi, Masoud Moosavinasab, Mohammadali Babaee,

More information

Guidelines for Titration onto Buprenorphine in Opioid Dependence

Guidelines for Titration onto Buprenorphine in Opioid Dependence NHS Fife Community Health Partnership Addiction Services Guidelines for Titration onto Buprenorphine in Opioid Dependence Intranet Procedure No. A7 Author Dr L. Cockayne Copy No 1 Reviewer Lead Clinician

More information

BUPRENORPHINE TREATMENT

BUPRENORPHINE TREATMENT BUPRENORPHINE TREATMENT Curriculum Infusion Package (CIP) Based on the Work of Dr. Thomas Freese of the Pacific Southwest ATTC Drug Addiction Treatment Act of 2000 (DATA 2000) Developed by Mountain West

More information

Opioid Treatment Services, Office-Based Opioid Treatment

Opioid Treatment Services, Office-Based Opioid Treatment Optum 1 By United Behavioral Health U.S. Behavioral Health Plan, California Doing Business as OptumHealth Behavioral Solutions of California ( OHBS-CA ) 2015 Level of Care Guidelines Opioid Treatment Services,

More information

Buprenorphine: what is it & why use it?

Buprenorphine: what is it & why use it? Buprenorphine: what is it & why use it? Dr Nicholas Lintzeris, MBBS, PhD, FAChAM Locum Consultant, Oaks Resource Centre, SLAM National Addiction Centre, Institute of Psychiatry Overview of presentation

More information

Disulfiram versus Placebo for Cocaine Dependence in Buprenorphine-Maintained Subjects: A Preliminary Trial

Disulfiram versus Placebo for Cocaine Dependence in Buprenorphine-Maintained Subjects: A Preliminary Trial Disulfiram versus Placebo for Cocaine Dependence in Buprenorphine-Maintained Subjects: A Preliminary Trial Tony P. George, Marek C. Chawarski, Juliana Pakes, Kathleen M. Carroll, Thomas R. Kosten, and

More information

Guidelines for the Prescribing, Supply and Administration of Methadone and Buprenorphine on Transfer of Care

Guidelines for the Prescribing, Supply and Administration of Methadone and Buprenorphine on Transfer of Care Hull & East Riding Prescribing Committee Guidelines for the Prescribing, Supply and Administration of Methadone and Buprenorphine on Transfer of Care 1. BACKGROUND Patients who are physically dependent

More information

Effects of Adding Behavioral Treatment to Opioid Detoxification With Buprenorphine

Effects of Adding Behavioral Treatment to Opioid Detoxification With Buprenorphine Journal of Consulting and Clinical Psychology Copyright 1997 by the American Psychological Association, Inc. 1997, Vol. 65, No. 5, 803-810 0022-006X/97/$3.00 Effects of Adding Behavioral Treatment to Opioid

More information

Medications for Alcohol and Opioid Use Disorders

Medications for Alcohol and Opioid Use Disorders Medications for Alcohol and Opioid Use Disorders Andrew J. Saxon, M.D. Center of Excellence in Substance Abuse Treatment and Education (CESATE) VA Puget Sound Health Care System Alcohol Pharmacotherapy

More information

Information for Pharmacists

Information for Pharmacists Page 43 by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose. Information for Pharmacists SUBOXONE (buprenorphine HCl/naloxone HCl

More information

Medication-Assisted Treatment for Opioid Addiction

Medication-Assisted Treatment for Opioid Addiction Medication-Assisted Treatment for Opioid Addiction This document contains a general discussion of medications approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of opioid

More information

Best Practices in Opioid Dependence Treatment

Best Practices in Opioid Dependence Treatment Best Practices in Opioid Dependence Treatment Anthony L. Jordan Health Center Linda Clark, MD, MS Medical Director Alana Ramos, BS Suboxone Clinic Manager Case Studies Nicole White female 27 years of age

More information

Adjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour.

Adjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour. Shared Care Guideline for Prescription and monitoring of Naltrexone Hydrochloride in alcohol dependence Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist,

More information

Naltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance

Naltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance Naltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance Introduction Indication/Licensing information: Naltrexone is licensed for use as an additional therapy, within

More information

This module reviews the following: Opioid addiction and the brain Descriptions and definitions of opioid agonists,

This module reviews the following: Opioid addiction and the brain Descriptions and definitions of opioid agonists, BUPRENORPHINE TREATMENT: A Training For Multidisciplinary Addiction Professionals Module II Opioids 101 Goals for Module II This module reviews the following: Opioid addiction and the brain Descriptions

More information

The Federation of State Medical Boards 2013 Model Guidelines for Opioid Addiction Treatment in the Medical Office

The Federation of State Medical Boards 2013 Model Guidelines for Opioid Addiction Treatment in the Medical Office The Federation of State Medical Boards 2013 Model Guidelines for Opioid Addiction Treatment in the Medical Office Adopted April 2013 for Consideration by State Medical Boards 2002 FSMB Model Guidelines

More information

Opioid Dependence Treatment with Buprenorphine/Naloxone: An Overview for Pharmacists and Physicians

Opioid Dependence Treatment with Buprenorphine/Naloxone: An Overview for Pharmacists and Physicians Opioid Dependence Treatment with Buprenorphine/Naloxone: An Overview for Pharmacists and Physicians Phyllis A. Grauer, PharmD, CGP, CPE Clinical Pharmacist Legislation Passed Enabling Office Based Treatment

More information

Hulpverleningsmodellen bij opiaatverslaving. Frieda Matthys 6 juni 2013

Hulpverleningsmodellen bij opiaatverslaving. Frieda Matthys 6 juni 2013 Hulpverleningsmodellen bij opiaatverslaving Frieda Matthys 6 juni 2013 Prevalence The average prevalence of problem opioid use among adults (15 64) is estimated at 0.41%, the equivalent of 1.4 million

More information

Community reinforcement approach for combined opioid and cocaine dependence Patterns of engagement in alternate activities

Community reinforcement approach for combined opioid and cocaine dependence Patterns of engagement in alternate activities Journal of Substance Abuse Treatment 18 (2000) 255 261 Article Community reinforcement approach for combined opioid and cocaine dependence Patterns of engagement in alternate activities Richard S. Schottenfeld,

More information

TENNESSEE BOARD OF MEDICAL EXAMINERS POLICY STATEMENT OFFICE-BASED TREATMENT OF OPIOID ADDICTION

TENNESSEE BOARD OF MEDICAL EXAMINERS POLICY STATEMENT OFFICE-BASED TREATMENT OF OPIOID ADDICTION TENNESSEE BOARD OF MEDICAL EXAMINERS POLICY STATEMENT OFFICE-BASED TREATMENT OF OPIOID ADDICTION The Tennessee Board of Medical Examiners has reviewed the Model Policy Guidelines for Opioid Addiction Treatment

More information

Effects of LAAM and Methadone Utilization in an Opiate Agonist Treatment Program

Effects of LAAM and Methadone Utilization in an Opiate Agonist Treatment Program Effects of LAAM and Methadone Utilization in an Opiate Agonist Treatment Program JUAN F. VALDIVIA, M.D. 1 AND SAMINA KHATTAK, M.D. 2 Abstract The development and approval of levo-alpha-acetylmethadol (LAAM)

More information

1. According to recent US national estimates, which of the following substances is associated

1. According to recent US national estimates, which of the following substances is associated 1 Chapter 36. Substance-Related, Self-Assessment Questions 1. According to recent US national estimates, which of the following substances is associated with the highest incidence of new drug initiates

More information

Pharmacotherapy for Opioid Addiction: Drugs in Development

Pharmacotherapy for Opioid Addiction: Drugs in Development Pharmacotherapy for Opioid Addiction: Drugs in Development Walter Ling MD UCLA/ISAP Pharmacotherapy for Prescription Opioid Addiction: Implications for Pain Management June 9-10, 2011 Boston, Mass. lwalter@ucla.edu

More information

EPIDEMIOLOGY OF OPIATE USE

EPIDEMIOLOGY OF OPIATE USE Opiate Dependence EPIDEMIOLOGY OF OPIATE USE Difficult to estimate true extent of opiate dependence Based on National Survey of Health and Mental Well Being: 1.2% sample used opiates in last 12 months

More information

Acute & Chronic Pain Management (requiring opioid analgesics) in Patients Receiving Pharmacotherapy for Opioid Addiction

Acute & Chronic Pain Management (requiring opioid analgesics) in Patients Receiving Pharmacotherapy for Opioid Addiction Acute & Chronic Pain Management (requiring opioid analgesics) in Patients Receiving Pharmacotherapy for Opioid Addiction June 9, 2011 Tufts Health Care Institute Program on Opioid Risk Management Daniel

More information

Patients are still addicted Buprenorphine is simply a substitute for heroin or

Patients are still addicted Buprenorphine is simply a substitute for heroin or BUPRENORPHINE TREATMENT: A Training For Multidisciplinary Addiction Professionals Module VI: Myths About the Use of Medication in Recovery Patients are still addicted Buprenorphine is simply a substitute

More information

Using Buprenorphine to Treat Acute Opioid Withdrawal in the ED

Using Buprenorphine to Treat Acute Opioid Withdrawal in the ED Using Buprenorphine to Treat Acute Opioid Withdrawal in the ED Dr. Karine Meador MD CCFP DABAM Assistant Director Inner City Health and Wellness Team Physician Addiction Recovery and Community Health (ARCH)

More information

Attending Physicians and Residents Attitudes and Beliefs About Prescribing Buprenorphine at an Urban Teaching Hospital

Attending Physicians and Residents Attitudes and Beliefs About Prescribing Buprenorphine at an Urban Teaching Hospital 336 May 2006 Family Medicine Clinical Research and Methods Attending Physicians and Residents Attitudes and Beliefs About Prescribing Buprenorphine at an Urban Teaching Hospital Chinazo O. Cunningham,

More information

MEDICAL ASSISTANCE BULLETIN

MEDICAL ASSISTANCE BULLETIN ISSUE DATE September 4, 2015 SUBJECT EFFECTIVE DATE September 9, 2015 MEDICAL ASSISTANCE BULLETIN NUMBER *See below BY Prior Authorization of Opiate Dependence Treatments, Oral Buprenorphine Agents - Pharmacy

More information

DEVELOPING MANUFACTURING SUPPLYING. Naltrexone Implants. Manufactured by NalPharm Ltd WWW.NALPHARM.COM

DEVELOPING MANUFACTURING SUPPLYING. Naltrexone Implants. Manufactured by NalPharm Ltd WWW.NALPHARM.COM DEVELOPING MANUFACTURING SUPPLYING Naltrexone Implants Background to Nalpharm NalPharm is a specialist pharmaceutical company supplying proprietary branded medications and generic drugs in the area of

More information

Medications for Alcohol and Drug Dependence Treatment

Medications for Alcohol and Drug Dependence Treatment Medications for Alcohol and Drug Dependence Treatment Robert P. Schwartz, M.D. Medical Director Rschwartz@friendsresearch.org Friends Research Institute Medications for Alcohol Dependence Treatment Disulfiram

More information

Developing Medications to Treat Addiction: Implications for Policy and Practice. Nora D. Volkow, M.D. Director National Institute on Drug Abuse

Developing Medications to Treat Addiction: Implications for Policy and Practice. Nora D. Volkow, M.D. Director National Institute on Drug Abuse Developing Medications to Treat Addiction: Implications for Policy and Practice Nora D. Volkow, M.D. Director National Institute on Drug Abuse Medications Currently Available For Nicotine Addiction Nicotine

More information

Course outline. Acupuncture in Mental Health. History of Acupuncture and Psychiatry in HK

Course outline. Acupuncture in Mental Health. History of Acupuncture and Psychiatry in HK Course outline Acupuncture in Mental Health Simon HUI Senior Physiotherapist Kwai Chung Hospital Updated evidences for using acupuncture in Mental health A literature review Local experience for using

More information

Medication treatments for opioid use disorders

Medication treatments for opioid use disorders Medication treatments for opioid use disorders Summary for counties JUDITH MARTIN, Medical Director of Substance Use Services, San Francisco Department of Public Health Brief history of Methadone and Buprenorphine

More information

Buprenorphine/Naloxone Maintenance Treatment for Opioid Dependence

Buprenorphine/Naloxone Maintenance Treatment for Opioid Dependence Buprenorphine/Naloxone Maintenance Treatment for Opioid Dependence Information for Family Members Family members of patients who have been prescribed buprenorphine/naloxone for treatment of opioid addiction

More information

Neurobiology and Treatment of Opioid Dependence. Nebraska MAT Training September 29, 2011

Neurobiology and Treatment of Opioid Dependence. Nebraska MAT Training September 29, 2011 Neurobiology and Treatment of Opioid Dependence Nebraska MAT Training September 29, 2011 Top 5 primary illegal drugs for persons age 18 29 entering treatment, % 30 25 20 15 10 Heroin or Prescription Opioids

More information

ST. CLAIR COUNTY COMMUNITY MENTAL HEALTH Date Issued: 07/09 Date Revised: 09/11;03/13;06/14;07/15

ST. CLAIR COUNTY COMMUNITY MENTAL HEALTH Date Issued: 07/09 Date Revised: 09/11;03/13;06/14;07/15 ST. CLAIR COUNTY COMMUNITY MENTAL HEALTH Date Issued: 07/09 Date Revised: 09/11;/13;06/14;07/15 WRITTEN BY Jim Johnson Page 1 REVISED BY AUTHORIZED BY Jessica Moeller Debra Johnson I. APPLICATION: THUMB

More information

Using Drugs to Treat Drug Addiction How it works and why it makes sense

Using Drugs to Treat Drug Addiction How it works and why it makes sense Using Drugs to Treat Drug Addiction How it works and why it makes sense Jeff Baxter, MD University of Massachusetts Medical School May 17, 2011 Objectives Biological basis of addiction Is addiction a chronic

More information

Methadone treatment Information for service users Page

Methadone treatment Information for service users Page South London and Maudsley NHS Foundation Trust Methadone treatment Information for service users Page What can happen if I stop using heroin? If you are addicted to or dependent on heroin, you develop

More information

METHADONE SUBSTITUTION THERAPY PROGRAM AND TOXICOLOGICAL STUDIES

METHADONE SUBSTITUTION THERAPY PROGRAM AND TOXICOLOGICAL STUDIES METHADONE SUBSTITUTION THERAPY PROGRAM AND TOXICOLOGICAL STUDIES Halina MATSUMOTO, El bieta WO NY, Anna DZIKLIÑSKA, Ma³gorzata ABRAMOWSKA Laboratory of Psychopharmacology, 1st Department of Psychiatry,

More information

American Society of Addiction Medicine

American Society of Addiction Medicine American Society of Addiction Medicine Public Policy Statement on Office-based Opioid Agonist Treatment (OBOT) BACKGROUND Methadone maintenance treatment of opioid addiction was developed in 1965 and implemented

More information

Buprenorphine and Naloxone Combination for Opioid Dependence

Buprenorphine and Naloxone Combination for Opioid Dependence DELHI PSYCHIATRY JOURNAL Vol. 13 No.1 APRIL 2010 Drug Review Buprenorphine and Naloxone Combination for Opioid Dependence M.S. Bhatia*, S. Srivastava*, G. Rajender*, S. Malhotra**, D. Chaudhary*** *Department

More information

MEDICATIONS USED IN THE MANAGEMENT OF SUBSTANCE USE DISORDERS

MEDICATIONS USED IN THE MANAGEMENT OF SUBSTANCE USE DISORDERS MEDIATIONS USED IN THE MANAGEMENT OF SUBSTANE USE DISORDERS Opioid Agonist Therapy (OAT) for Opioid Dependence Methadone (Dolophine, Methadose) Specialty consultation advised. Titrate carefully, consider

More information

Assessment and Management of Opioid, Benzodiazepine, and Sedative-Hypnotic Withdrawal

Assessment and Management of Opioid, Benzodiazepine, and Sedative-Hypnotic Withdrawal Assessment and Management of Opioid, Benzodiazepine, and Sedative-Hypnotic Withdrawal Roger Cicala, M. D. Assistant Medical Director Tennessee Physician s Wellness Program Step 1 Don t 1 It is legal in

More information

Policy #: 457 Latest Review Date: December 2010

Policy #: 457 Latest Review Date: December 2010 Effective for dates of service on or after January 1, 2015 refer to: https://www.bcbsal.org/providers/drugpolicies/index.cfm Name of Policy: Naltrexone (Vivitrol ) Injections Policy #: 457 Latest Review

More information

Objectives. Dosing Methadone and Suboxone 2016. Methadone. Methadone

Objectives. Dosing Methadone and Suboxone 2016. Methadone. Methadone Objectives The Pharmacokinetics and Pharmacodynamics of methadone and buprenorphine Therapeutic implications Why we dose the way we do Dosing and Suboxone 2016 Does Not Have a Sense of Humor A long acting,

More information

Jennifer Sharpe Potter, PhD, MPH Associate Professor Division of Alcohol and Drug Addiction Department of Psychiatry

Jennifer Sharpe Potter, PhD, MPH Associate Professor Division of Alcohol and Drug Addiction Department of Psychiatry Buprenorphine/Naloxone and Methadone Maintenance Treatment Outcomes for Opioid Analgesic, Heroin, and Combined Users: Findings From Starting Treatment With Agonist Replacement Therapies (START) Jennifer

More information

The Results of a Pilot of Vivitrol: A Medication Assisted Treatment for Alcohol and Opioid Addiction

The Results of a Pilot of Vivitrol: A Medication Assisted Treatment for Alcohol and Opioid Addiction The Results of a Pilot of Vivitrol: A Medication Assisted Treatment for Alcohol and Opioid Addiction James H. Barger, MD SAPC Medical Director and Science Officer Desiree A. Crevecoeur-MacPhail, Ph.D.

More information

Appendix to Tennessee Department of Health: Tennessee Clinical Practice Guidelines for Outpatient Management of Chronic Non- Malignant Pain

Appendix to Tennessee Department of Health: Tennessee Clinical Practice Guidelines for Outpatient Management of Chronic Non- Malignant Pain Appendix to Tennessee Department of Health: Tennessee Clinical Practice Guidelines for Outpatient Management of Chronic Non- Malignant Pain Division of Workers Compensation 04.01.2015 Background Opioids

More information

SROM (oral morphine) an add on medication for the treatment of opioid dependence: risks & benefits. Gabriele Fischer. Medical University Vienna

SROM (oral morphine) an add on medication for the treatment of opioid dependence: risks & benefits. Gabriele Fischer. Medical University Vienna ATHS Biarritz oct 1 th, 2015 SROM (oral morphine) an add on medication for the treatment of opioid dependence: risks & benefits Gabriele Fischer gabriele.fischer@meduniwien.ac.at Medical University Vienna

More information

SCOTTISH PRISON SERVICE DRUG MISUSE AND DEPENDENCE OPERATIONAL GUIDANCE

SCOTTISH PRISON SERVICE DRUG MISUSE AND DEPENDENCE OPERATIONAL GUIDANCE SCOTTISH PRISON SERVICE DRUG MISUSE AND DEPENDENCE OPERATIONAL GUIDANCE 1 P a g e The following Operational Guidance Manual has been prepared with input from both community and prison addictions specialists

More information

Beyond SBIRT: Integrating Addiction Medicine into Primary Care

Beyond SBIRT: Integrating Addiction Medicine into Primary Care Beyond SBIRT: Integrating Addiction Medicine into Primary Care Community Clinic Association of Los Angeles County 14 th Annual Health Care Symposium March 6, 2015 Keith Heinzerling MD, Karen Lamp MD; Allison

More information