Medication Assisted Treatment of Substance Use Disorders

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1 Medication Assisted Treatment of Substance Use Disorders April 8, 2015

2 We Want To Hear From You! Type questions into the Questions Pane at any time during this presentation

3 Patient-Centered Primary Care Institute Online Modules Webinars Website Learning Collaboratives Trainings TA Network

4 PCPCH Model of Care Oregon s PCPCH Model is defined by six core attributes, each with specific standards and measures Access to Care Health care team, be there when we need you Accountability Take responsibility for making sure we receive the best possible health care Comprehensive Whole Person Care Provide or help us get the health care, information and services we need Continuity Be our partner over time in caring for us Coordination and Integration Help us navigate the health care system to get the care we need in a safe and timely way Person and Family Centered Care Recognize that we are the most important part of the care team - and that we are ultimately responsible for our overall health and wellness Learn more:

5 Introduce Presenter Ron Jackson, M.S.W., L.I.C.S.W. Affiliate Professor School of Social Work University of Washington

6 Learning Objectives To understand the various FDA-approved medications currently available to assist in the treatment of Substance Use Disorders To understand the interaction between MAT and addiction recovery To understand implementation barriers and strategies

7 Substance Use Disorder DSM 5 Tolerance* Withdrawal* More use than intended Craving for the substance Unsuccessful efforts to cut down Spends excessive time in acquisition Activities given up because of use Uses despite negative effects Failure to fulfill major role obligations Recurrent use in hazardous situations Continued use despite consistent social or interpersonal problems *not counted if prescribed by a physician Severity measured by number of symptoms: 2-3 mild 4-6 moderate 7-11 severe

8 Terminology Dependence versus Addiction Addiction may occur with or without the presence of physical dependence. Physical dependence results from the body s adaptation to a drug or medication and is defined by the presence of Tolerance and/or Withdrawal

9 Addiction Involves Multiple Factors Biology/Genes Environment DRUG Brain Mechanisms Addiction

10 Drug Dependence: A Chronic Medical Illness Genetic Heritability twin studies Hypertension 25-50% Diabetes Type 1: 30-55%; Type 2: 80% Asthma 36-70% Nicotine 61% (both sexes) Alcohol 55% (males) Marijuana 52% (females) Heroin 34% (males) Voluntary Choice shaped by personality and environment Pathophysiology neurochemical adaptations Treatment Response Medications effectiveness and compliance Behavioral interventions McLellan, A.T., et.al., Drug Dependence, a Chronic Medical Illness Journal of the American Medical Association 284: , 2000.

11 If Addiction is a Chronic Disease: Addiction treatment doesn t cure the disease. The goal of treatment is to: Provide patients the tools to help them manage their addiction and medications are among those tools Teach them how to use those tools to achieve and maintain recovery

12 Psychological and Social Problems X Counseling & social supports Addiction Opioid addiction treatment medicines X Brain changes and Dependence

13 Medications Available Opiates Methadone Agonist Buprenorphine Partial Agonist Naltrexone - Antagonist Alcohol Disulfiram (Antabuse ) Naltrexone (Revia, Vivitrol ) Acamprosate (Campral )

14 Addiction Treatment Medications The Evidence Base Medication Cochrane Review # of scientific papers in PubMed Disulfiram No 3,640 Naltrexone Yes 7,215 Acamprosate Yes 552 Methadone Yes 11,784 Buprenorphine Yes 3,869

15 Medications Available Cocaine Two Vaccines under trials Nicotine Gum, patches, nasal sprays Buproprion (Zyban, Wellbutrin ) Varenicline (Chantix ) Vaccine under trials Other (Amphetamine, Marijuana) Nothing Yet

16 Medications for Alcohol Addiction

17 How Can We Treat Alcohol Addiction? Medications for alcoholism can: Reduce post-acute withdrawal Block or ease euphoria from alcohol Discourage drinking by creating an unpleasant association with alcohol

18 Disulfiram Antabuse

19 Disulfiram Marketed as Antabuse FDA Approved in 1951 Indication: An aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disfulfiram discourages drinking by making the patient physically sick when alcohol is consumed. Has not been found to be addictive and no reports of misuse

20 Additional Disulfiram Information Cost: Prices vary by pharmacy $26 83 for 30 tabs Third-Party Payer Acceptance: Covered by most major insurance carriers, Medicare, Medicaid, and the VA Dosing: One 250mg tablet, once a day Can be crushed, diluted or mixed with food Abstinence Requirements: Must be taken at least 12 hours after last alcohol use

21 How Does Disulfiram Work? Alcohol Dehydrogenase Acetaldehyde Dehydrogenase Disulfiram works by blocking the enzyme acetaldehyde dehydrogenase. This causes acetaldehyde to accumulate in the blood at 5 to 10 times higher than what would normally occur with alcohol alone.

22 How Does Disulfiram Work? Since acetaldehyde is poisonous, a buildup of it produces a highly unpleasant series of symptoms, which is commonly referred to as the disulfiramalcohol reaction. throbbing in head/neck brief loss of consciousness throbbing headache lowered blood pressure difficulty breathing marked uneasiness copious vomiting nausea flushing sweating thirst weakness chest pain dizziness palpitation hyperventilation rapid heartbeat blurred vision confusion respiratory depression cardiovascular collapse myocardial infarction congestive heart failure unconsciousness convulsions death

23 Disulfiram Contraindications The disulfiram-alcohol reaction usually lasts for 30 to 60 minutes, but can continue for several hours depending on the amount of alcohol consumed Should never be administered to a patient when he or she has consumed alcohol recently or is currently intoxicated from alcohol Should never be administered to a patient that has consumed alcohol-containing preparations such as cough syrup, tonics, etc.

24 Acamprosate Campral

25 Acamprosate Calcium Marketed as Campral FDA Approved in 2004 Indication: For the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation by reducing post-acute withdrawal symptoms. Has not been found to be addictive and no reports of misuse

26 Additional Information Cost: $ per month, which is around $4.53 a day 46 Third-Party Payer Acceptance: Patient Assistance Program (Forest Laboratories, Inc.) Covered by most major insurance carriers Covered by Medicare, Medicaid, and the VA (if naltrexone is contraindicated) Dosing: Two 333mg tablets, three times a day Cannot be crushed, halved or diluted, but can be mixed with food

27 Features of Alcohol Dependence Normal Acute Alcohol Intake Tolerance Alcohol Alcohol Adaptation Inhibition (GABA) Excitation (Glutamate) Acute Withdrawal Adaptation Post-Acute Withdrawal Adaptation Source: De Witte. Addict Behav. 2004;29(7): Extended symptoms (eg, sleep/mood disturbances)

28 How Does Acamprosate Work? Even after acute withdrawal, the glutamate system continues to be overactive as it readjusts by down regulating the glutamate receptors During this time, the client continues to feel anxiety and agitation that can lead to relapse Glutamate excitability associated with physiological craving Believed to decrease cravings by normalizing GABA and glutamate

29 Naltrexone Revia or Depade

30 Naltrexone Hydrocholoride Marketed As: ReVia and Depade Indication Used in the treatment of alcohol or opioid dependence and for the blockade of the effects of exogenous administered opioids and/or decreasing the pleasurable effects experienced by consuming alcohol Has not been found to be addictive or produce withdrawal symptoms when the medication is ceased. Administering naltrexone will invoke opioid withdrawal symptoms in patients who are physically dependent on opioids.

31 Additional Information Cost: $40-60 per month Third-Party Payer Acceptance: Covered by most major insurance carriers, Medicare, Medicaid, and the VA Dosing: One 50mg tablet, once a day Can be crushed, diluted or mixed with food Abstinence requirements: must be taken at least 7-10 days after last consumption of opioids; abstinence from alcohol is not required

32 How Does Naltrexone Work? Naltrexone is an opioid receptor antagonist and blocks opioid receptors. This prevents the effects of selfadministered opioids. It also diminishes release dopamine when alcohol is consumed, reducing the pleasurable effects. Naltrexone

33 Naltrexone for Extended-Release Injectable Suspension Vivitrol

34 Extended-Release Naltrexone Dosing: One 380mg injection deep muscle in the buttock every 4 weeks Must be administered by a healthcare professional and should alternate buttocks each month. Blocks opioid receptors for one entire month compared to approximately 28 doses of oral naltrexone. It is not possible to remove it from the body once extended-release naltrexone has been injected. Pricing: $ per month (one injection)

35 Special Precautions for Extended-Release Naltrexone During clinical trials, there was an increase in adverse events of a suicidal nature in patients taking extendedrelease naltrexone. Counselors should continue to closely monitor and record all suicidal events for patients, including those taking extended-release naltrexone. If opioid analgesia is required, it should be noted that the patient may necessitate greater than usual amounts of opioids to achieve desired effect, and the resulting respiratory depression may be deeper and more prolonged.

36 Medications for Opioid Addiction

37 How do Medications for Opioid Addiction Work? There are three types of medications that can block the high : Agonists produce opioid effects Partial Agonists produce moderate opioid effects Antagonists block opioid effects

38 How do Medications for Opioid Addiction Work? Opioid Effect Full Agonist (e.g., methadone) Dose of Opioid Partial Agonist (e.g. buprenorphine) Antagonist (e.g. Naloxone)

39 The Research Research clearly and consistently shows that medication assisted treatment for opioid use disorder saves lives and money mortality rates were 75 percent higher among those receiving drug-free treatment compared to those receiving buprenorphine (or methadone) Health Affairs, August 2011 vol. 30 no

40 How does Methadone Work? Methadone binds to the same receptor sites as other opioids Orally effective Slow onset of action Long duration of action Slow offset of action

41 Treatment Outcome Data: Methadone 8-10 fold reduction in death rate Reduction of drug use Reduction of criminal activity Engagement in socially productive roles; improved family and social function Increased employment Improved physical and mental health Reduced spread of HIV Excellent retention

42 Methadone & Pregnancy Fetal outcomes better on MMT than heroin Detoxification from opiates risky for fetus Methadone dose adjustments during pregnancy May need split dosing to improve serum stability Attention to prenatal care during pregnancy Some infants have abstinence syndrome within 72 hrs. of birth; may require pharmacotherapy NAS may be associated with mothers level of smoking during pregnancy (Choo, et.al., 2004) Breastfeeding OK with MMT unless otherwise contraindicated, e.g., blood-borne infections For further information see TIP 43, Chapter 13

43 Methadone Maintenance vs. 180 Day Detoxification 12 month study of 179 opioid dependent patients randomly assigned to: Methadone Maintenance mean dose=85.3mg for 14 months 180 Day Methadone Detoxification mean dose=86.3 mg prior to taper at 120 days followed by psychosocial Tx for 8 months Methadone maintenance therapy resulted in greater treatment retention and lower heroin use rates than did detoxification. K.L. Sees et al., JAMA 2000

44 But Aren t they Still Addicted? What is the definition of addiction? Is it simply physical dependence? How does the change of lifestyle and psychosocial stability associated with long-term methadone treatment fit with that definition?

45 Buprenorphine Buprenorphine/ Naloxone

46 Formulations of Buprenorphine Buprenorphine is currently marketed for opioid treatment under the trade names: Subutex (buprenorphine) Zubsolv Suboxone (buprenorphine/naloxone) Suboxone Sublingual Film (buprenorphine/naloxone) (buprenorphine/naloxone) 5.7 mg. bup./1.4 mg. nalox. 1.4 mg. bup./0.36 mg. nalox. 46

47 Drug Addiction Treatment Act of 2000 (DATA 2000) Expands treatment options to include both the general health care system and opioid treatment programs Expands number of available treatment slots Allows opioid treatment in office settings Sets physician qualifications for prescribing the medication

48 DATA 2000: Physician Qualifications Physicians must: Be licensed to practice by his/her state Have the capacity to refer patients for psychosocial treatment Originally limited to 30 patients later expanded to allow for 100 patients after the first year of experience Be qualified to provide buprenorphine and receive a license waiver

49 Physician-Based vs. Clinic-Based Treatment In clinic-based treatment there are many rules (observed dosing, counseling, urinalysis), imposed by regulatory authorities (federal & state) Physician-based treatment has no such rules, only guidelines Physician-based perhaps more geographically available and certainly more private

50 Specific Research on Buprenorphine and Pregnancy MOTHER Study, Jones, et.al., 2010 Randomized double blind, double dummy comparison between methadone and buprenorphine (Subutex ) in pregnant women in a large multi-site trial Women dosed daily under observation 7 days per week No difference in NAS frequency in babies born to mothers on either medication Two statistically significant findings: shorter hospital stay for buprenorphine, less NAS medication used No data available to inform determination of patients who should be maintained on methadone rather than buprenorphine Comprehensive integrated services and daily observation (methadone clinic) vs. office based medication

51 The Prescription Opioid Addiction Treatment Study (POATS) Largest study ever conducted for prescription opioid dependence 653 participants enrolled Compared treatments for prescription opioid dependence, using buprenorphine-naloxone and counseling Conducted as part of NIDA Clinical Trials Network (CTN) at 10 participating sites across U.S. Examined detoxification as initial treatment strategy, and for those who were unsuccessful, how well buprenorphine stabilization worked 51

52 Take Home Messages Tapering from buprenorphine-naloxone, whether initially or after a period of substantial improvement, led to nearly universal relapse Medication Management (MM) produced outcomes equal to MM+ individual opioid drug counseling Patients with chronic pain had outcomes equal to those without chronic pain 52

53 Opioid Antagonists Naltrexone Naltrexone for Extended-Release Injectable Suspension Revia or Depade Vivitrol

54 Heroin Overdose Prevention Studies have shown that heroin overdose is a preventable manner of death Methods for overdose prevent include the following: Education of heroin users about dangerous drug interactions Education about rescue breathing and Good Samaritan laws Naloxone (Narcan ) distribution and education about its use CSAT has published its Overdose Prevention Kit

55 Nicotine Treatment Medications Nicotine replacement Gum, patches, nasal sprays, lozenges Bupropion (Zyban, Wellbutrin ) Varenicline (Chantix ) Approved in 2006 Nicotinic receptor partial agonist Vaccine under trials

56 Resistance to Medications Many reasons for resistance to medication Anticipated unpleasant side effects Cost of medication Burden of taking daily medication Denial about condition or disease Influence of others Negative perception of addiction medications

57 What Questions Do You Have? Type questions into the Questions Pane at any time during this presentation

58 Resources Buprenorphine SAMHSA - Reckitt Benckiser Zubsolv - Extended-Release Injectable Naltrexone Clinical Use of Extended-Release Injectable Naltrexone in the Treatment of Opioid Use Disorders: A Brief Guide

59 More Resources TIP 40: Clinical Guidelines for the Use of Buprenorphine for the Treatment of Opioid Dependence (SAMHSA-CSAT) TIP 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs (SAMHSA-CSAT) Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends (SAMHSA-CSAT) Please complete post-webinar survey

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