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

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1 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. Research Psychologist, UCLA ISAP

2 How Do Drugs Act on the Brain?

3 Changes in Brain Chemistry Drugs of abuse produce their effects by altering brain chemistry. Neurotransmitters and associated receptors responsible for everyday functions are altered by the consumption of drugs. Some of the changes in neurotransmitter activity have a clear relationship to the desired effects of using.

4 Natural Reward vs. Substance-Induced Reward Dopamine transmission: Natural reinforcer People seek out experiences that feel good. These experiences are natural reinforcers. Natural reinforcers stimulate release of dopamine. Dopamine transmission: Substance-induced Nearly all drugs of abuse also increase dopamine availability. 1-2 Dopamine release in the nucleus accumbens is 3-5 times greater for substances than natural reinforcers. 3

5 Addiction as a Brain Disease Many drugs of abuse can cause lasting changes to brain chemistry, particularly the dopamine reward pathway. Limited availability of dopamine in key regions of the brain may desensitize the reward circuit to natural reinforcers. Clients may choose continued substance use to overcome a deficit in dopamine availability.

6 Naltrexone and Other Medications

7 Medications for Alcohol Use Disorders Antabuse (Disulfiram) Interrupts the metabolism of alcohol Creates an unpleasant physical reaction Acamprosate (Campral) Glutamate excitability associated with physiological craving Believed to decrease cravings by normalizing GABA and glutamate

8 Medications for Opiate Use Disorders Methadone High doses of methadone alleviate patient cravings for opioids. Daily dosing required due to risk of withdrawal when time between dosing exceeds 36 hours. Suboxone= Buprenorphine + Naloxone Naloxone combined with Buprenorphine to reduce potential for abuse Naloxone is a powerful opioid receptor antagonist that will displace other opioids and precipitate withdrawal.

9 Oral Naltrexone (Revia) Approved by the FDA for alcohol dependence in 1984 Naltrexone is an opiate receptor antagonist that dampens the perceived reward or pleasure of drinking. Naltrexone interferes with dopamine transmission and diminishes the perceived reinforcing effects of alcohol.

10 What is Vivitrol? Injectable extended release naltrexone was FDA approved in 2006, for the treatment of alcoholism In 2011, the FDA approved Vivitrol for the treatment of opiate addiction. An opioid receptor antagonist, that blocks the mu-opioid receptors in the brain Mu-opioid receptors are responsible for the high or buzz individuals feel when alcohol is consumed or opiates are used.

11 Partial/Full Agonist, Antagonist, What s the Difference?

12 Agonist Medications Have similar structure and bind to same receptor sites as drug of abuse Provide full activation at receptor site where it binds Example: Methadone is a full agonist a synthetic opioid that binds to the receptors activated by heroin and other opioids Occupies mu opioid receptor Provides relief from craving and withdrawal If taken as prescribed, user does not experience euphoria or intoxication

13 Partial Agonist Medications Similar structure and bind to same receptor sites as drug of abuse Provide partial activation at receptor site Provide relief from craving and withdrawal Degree of activation less than a full agonist Block full agonists from binding at receptor sites Limit drug s effect if substance is subsequently used Example: Buprenorphine is a partial agonist at the mu opioid receptor

14 Antagonist Medications Decrease pleasure and reward from drug use Have similar structure and bind to same receptor sites as drug of abuse Provide no activation at receptor site where it binds Block full and partial agonists from binding at receptor sites May induce withdrawal symptoms when full agonist drugs are displaced by antagonist medication

15 Vivitrol is a Mu Opioid Receptor Antagonist

16 Precautions with Vivitrol Client must be abstinent from all opiates for at least 10 days. Ideally, client must be abstinent from alcohol for at least 7 days. Not approved for anyone under 18 or pregnant or nursing women Not approved for anyone with active hepatitis or elevated liver enzymes

17 Benefits of Vivitrol Reduces the number of risky and heavy drinking days (Garbutt et al., 2005; Lee et al., 2010; Manelli, 2007) Effective in relapse prevention for heroin users (Krupitsky, & Blokhina, 2010). Improves individuals quality of life (Pettinati et al., 2009; Schmitz et al., 2001).

18 Combining Counseling with Medication Medications enhance the effectiveness of counseling Improved compliance in methadone maintenance Augmenting cognitive behavioral therapy with naltrexone increases periods of abstinence and decreases rates of heavy drinking Ease discomfort of withdrawal symptoms in early recovery associated with improved retention

19 Resistance to Medications Common reasons given for client resistance to medication 1.Anticipated unpleasant side effects 2.Cost of medication 3.Burden of taking daily medication 4.Denial about condition or disease 5.Influence of others 6.Negative perception of addiction medications

20 Los Angeles County Vivitrol Pilot Project

21 Evaluation Questions Do LA County SAPC clients remain on Vivitrol beyond the 1st dose? Does medication affect client outcomes? Length of stay, reported use of alcohol, retention and engagement Does staff knowledge and attitudes toward medication assisted treatment improve at 4 month follow-up compared to baseline, as a result of trainings?

22 Evaluation Design The three medication hubs: Tarzana Treatment Center (main hub) Behavioral Health Services Prototypes. Selection criteria: Infrastructure (staff, examination room, refrigerated and locked location for medication storage) to administer medications Long-standing histories of providing quality substance abuse treatment to a broad range of clients

23 Treatment Outcome Data Methods Los Angeles County Participant Reporting System (LACPRS) Patient Response to Vivitrol Medically Assisted Treatment Survey (MATS) Urge to Drink Scale (UDS) Counselors Attitude Counselor Attitude Survey Staff at treatment sites would gather the required data and submit to UCLA for analysis

24 Results and Conclusions All Results Significant at p<.05 or better

25 Participant Characteristics Overall N (%) Detoxification Participants n (%) Treatment Participants n (%) Total 387 (100%) 96 (24.8%) 233 (60.2%) Male 195 (50.4%) 65 (67.7%) 101 (43.3%) Female 192 (49.6%) 31 (32.3% 132 (56.7%) Race/Ethnicity White 205 (53%) 65 (67.7%) 103 (44.2%) Hispanic/Latino 124 (32%) 22 (22.9%) 90 (38.6%) African American 38 (9.8%) 2 (2.1%) 30 (12.9%) Asian American/Pacific Islander 5 (1.3%) 4 (2.0%) 0 (0.0% American Indian/Alaskan Native 3 (0.8%) 1 (1.0%) 2 (0.9%) Other 12 (3.1%) 2 (2.1%) 8 (3.4%) Mean Age 38.0 years 39.8 years 27.9 years

26 Vivitrol Doses by Site Total (N=399) Tarzana (n=290) Prototypes (n=39) BHS (n=70) Average # of Doses Mode Minimum # of Doses Maximum # of Doses Injections Received One Dose Only, % (n) 41.1% (164) 45.5% (132) 28.2% (11) 30.0% (21) Two Doses Only, % (n) 22.6% (90) 22.1% (64) 30.8% (12) 20.0% (14) Three Doses Only, % (n) 12.3% (49) 11.4% (33) 15.4% (6) 13.3% (10) Four or More Doses, % (n) 24.0% (96) 21.0% (61) 25.6% (10) 36.7% (26)

27 Reduced Urge to Drink Based on the Urge to Drink Scale, which is scored from 0 to 30.

28 Limited Side Effects Proportion Reporting Side Effect for Weeks 1 4 After First Dose

29 Treatment Clients Reduced Primary Drug Use Reduction in Primary Drug Use Days for Treatment (In Past 30 Days) Mean Days in Past All Treatment Clients Outpatient Clients Residential Clients Admission Discharge

30 Higher Abstinence Rates among Vivitrol Treatment Clients Reduction in Primary Drug Use Days for Treatment (In Past 30 Days) % Abstinent at Discharge % 83.1% 81.6% 90.3% 0 Outpatient County Average Residential Vivitrol Treatment Clients

31 Higher Engagement Rates among Vivitrol Treatment Clients Engagement Rates of L.A. County Clients vs. Vivitrol Treatment Clients % 88.2% 79.6% 94.3% % Engagement % 64.2% 25 0 Overall Outpatient Residential County Average Vivitrol Treatment Clients

32 Higher Completion Rates among Vivitrol Treatment Clients 100 Completion Rates of L.A. County Clients vs. Vivitrol Treatment Clients % Completed % 33.6% 32.9% 46.6% 39.2% 64.1% 25 0 Overall Outpatient Residential County Average Vivitrol Treatment Clients

33 Improved Counselor Attitudes Counselor attitudes improved over the course of the project and many who initially reported neutral or negative attitudes towards medication-assisted treatment in general or Vivitrol in particular, reported positive attitudes on the follow-up survey.

34 Take Away Points Good medication adherence: 68% Few side effects: Less than 25% reported any single side effect. Decrease Use: Clients reported significant decreases in alcohol use reducing their use from 17 days to less than 2 days per month in the past 30 days.

35 Success Stories

36 45-year-old, Latina female who has been trying to stop drinking for 15 years. She has been in over 20 detoxes and this is her fifth time in residential treatment. This is the first time, thanks to Vivitrol, that she has lost the craving for alcohol since she began drinking as an adolescent.

37 52-year-old, Caucasian male who has been drinking since 14 years of age. He tried to stop drinking for 25 years on his own or through 12-step programs. He never achieved more than 3-4 months of sobriety at a time. This is his 2 nd Tx program; in his first program he lasted two months thinking about drinking every single day. I couldn t get it out of my head, so I left. Currently, he has received 2 Vivitrol injections and has been able to concentrate on the counseling work since the third day after his first injection. He was on a pass last week and passed the liquor store where he has been keeping a tab for 15 years and didn t even realize I went by it until I was three blocks away. Vivitrol is fantastic!

38 36-year-old, American Indian male with a 20-year history of alcohol and methamphetamine abuse and a co occurring diagnosis of bipolar disorder. He has been in treatment 4 times since he began trying to stop using 8 years ago. While he did manage to stop using meth 4 years ago, his daily drinking has been steadily getting worse over the last two years, most often leading to blackouts. He has received 4 Vivitrol injections so far and says he has not had any urges to drink since a couple of days after the first shot.

39 In this pilot, Vivitrol Conclusions Increased the number of clients who complete treatment in detoxification, outpatient counseling and residential treatment programs. Decreasing substance use in outpatient counseling and residential treatment Increasing treatment engagement (outpatient and residential) and treatment continuance for residential treatment.

40 Next Steps Write up results for presentations at conferences and meetings as well as for journal publications Assess urges once Vivitrol is no longer being taken short-term follow-up Address Board Amendments

41 Current Study: Follow-Up Collect UDS and MATs on new clients Conduct 30 and 60 day post final dose followups to examine Pattern in urges to drink/use Do urges return at same level, lower level or higher Examine reported patterns of use Is sobriety that is earned in treatment maintained after treatment ends Interviews and drug tests

42 Los Angeles County Board of Supervisors Amendments SAPC to report in 90 days on: 1. Policy changes needed to expand the availability of Vivitrol (Medi-Cal) 2. Recommendations on how Vivitrol can be purchased at the most affordable price SAPC to report in 12 Months on: 1. The efficacy of Vivitrol and MAT as cost effective measures to improve outcomes 2. Recommendations for use in high risk, high consequence populations

43 Acknowledgements For allowing the use of their slides, thanks to Eric Devine, Ph.D. is and Assistant Professor of Psychiatry at the Boston University School of Medicine and training Faculty for the Boston Center for Treatment Development and Training (BCTDT). Join Together is a program of the Boston University School of Public Health.

44 Questions?

45 Thank You! James H. Barger, MD (626) Desiree A. Crevecoeur-MacPhail, Ph.D. (310)

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