Medications for Alcohol and Opioid Use Disorders

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1 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

2 Alcohol Pharmacotherapy in VA Harris et al., 2010

3 Medications for Alcohol Use Disorders Disulfiram (Antabuse) Naltrexone (ReVia, Vivitrol) FDA Approved Acamprosate (Campral) Topiramate Under investigation

4 Disulfiram H 5 C 2 C 2 H 5 N C S S C N H 5 C 2 S S C 2 H 5 Tetraethylthiuram - Synthesized by Danish scientists in the 1930 s as an antihelminthic; a non-specific inhibitor of sulfhydryl-containing enzymes

5 Disulfiram

6 Disulfiram-Alcohol Reaction Related to acetaldehyde buildup Flushing Sweating Nausea and Vomiting Headache Tachycardia Sometimes hypotension Sometimes dyspnea

7 Disulfiram Treatment Effects Fuller et al., 1986 Partially blinded, controlled, randomized trial in 9 VA s

8

9 Disulfiram Treatment Effects Fuller et al., 1986 Alcohol Consumption During the Study Drinking Days Reported by Subjects Drinking Days Reported by SO's 250 mg 1 mg None 49.0± ± ± ± ± ±16.3

10 Disulfiram Pharmacokinetics Rapidly absorbed and Dosing Peak Plasma levels 9 hrs t 1/2 =7.3 hrs Metabolized to diethyldithiocarbamate, diethyldithiocarbamate-methyl ester, diethylamine, and carbon disulfide Usual dose=250 mg q d. Patient should be alcohol abstinent for a minimum of 48 hours before starting disulfiram

11 Disulfiram Side Effects Hepatotoxicity Occurs 1/25,000 patient-years of tx Mechanism unknown Potentially fatal

12

13

14 Effects of Naltrexone on Relapse Rates among Alcohol Dependent Outpatients Proportion Not Relapsing Naltrexone Placebo Number of Weeks Receiving Medications Volpicelli, et al., 1992

15 Naltrexone Oral Pharmacokinetics and dosing Rapidly absorbed Rapidly transformed to an active metabolite, 6-β-Naltrexol Peak Plasma levels in 1 hr. 10:1 ratio of metabolite:parent t 1/2 =4 hrs for naltrexone =12 hrs for 6-β-Naltrexol Usual dose=50 mg q d (?optimum dose)

16 Long-Acting Injectable Naltrexone Clinical Trial 24-week multicenter, randomized, double-blind, placebo-controlled study 624 alcohol-dependent patients (DSM-IV) Subgroup abstinent prior to treatment initiation 82 patients (13.1%) abstinent for 4 days 53 patients (8.5%) abstinent for 7 days Patients who were abstinent for 7 days were stratified for equal distribution across treatment groups Treatment consisted of 12 sessions of low-intensity psychosocial intervention (BRENDA) plus 6 monthly IM injections of either: Placebo, XR-NTX 190 mg, or XR-NTX 380 mg

17 Reduction in Heavy Drinking Days Median number heavy drinking days/month *P<0.05 vs placebo Baseline Placebo XR-NTX 190 mg All patients (N=624) 3.1* XR-NTX 380 mg 48%

18 Monthly Rate of Self-Help Meeting Attendance Mean % subjects All patients (N=624) PBO XR-NTX 190 mg XR-NTX 380 mg Month

19 Acamprosate

20

21 Acamprosate Treatment Effects Continuous Abstinence 48-Week Study 100 ACAMP, 1332/1998 mg/d (n=136) Placebo (n=136) P=.005 P=.003 Percentage of Patients Abstinent Treatment Period Days Follow-up Period Source: Sass H, et al. Arch Gen Psychiatry. 1996;53:

22 Acamprosate Pharmacokinetics and Dosing Poorly absorbed (bioavailability~50%) Peak Plasma Levels 1 hr. Eliminated by renal excretion (not metabolized by liver) t 1/2 =17 hrs Clinical dosing 666 mg (two 333 mg tabs) three times daily

23 Johnson et al., 2007 Topiramate for Alcohol Use Disorder Dose titrated to 300 mg/d by week 5 Minimum dose=50mg/d, Mean=171.4 (SD=107.6)

24 Pettinati et al., 2009 Combining Sertaline (200 mg/d) and Naltrexone (100 mg/d) for Co-occuring Depression and Alcohol Dependence p=.01

25 Naltrexone for Opioid Use Disorder Most ideal pharmacologic treatment Requires medically supervised withdrawal before initiation or severe withdrawal will be precipitated Requires Naloxone challenge test Risk of OD if medication stopped In general poor patient compliance but superb treatment for selected patients

26 Depot Naltrexone to Block Heroin Effect Comer et al., 2002

27 Injectable Extended Release Naltrexone for Opioid Use Disorder Krupitsky, et al., 2011

28 Experimental Group (Methadone) Swedish Methadone Study Before Control Group (No Methadone) Gunne & Gronbladh, 1981

29 Swedish Methadone Study Experimental Group (Methadone) After 2 Years Control Group (No Methadone) a b c d d d Gunne & Gronbladh, 1981 a Sepsis b Sepsis and Endocarditis c Leg Amputation d In Prison

30 Properties of Buprenorphine (a Partial µ-opioid Agonist) Ceiling effect on respiratory depression Less physical dependence capacity Relieves withdrawal in patients already in withdrawal Precipitates withdrawal in patients with other opioids on board

31 Efficacy: Full Agonist (Methadone) Partial Agonist (Buprenorphine), Antagonist (Naloxone) Full Agonist (Methadone) % Maximal Effect Partial Agonist (Buprenorphine) Antagonist (Naloxone) Log Dose of Opioid

32 Buprenorphine Pharmacology Extensive first pass metabolism given Sub-Lingual or buccal Slow onset, long duration (24-48 hours) Slow offset Half life > 24 hours Once a day or every other day dosing

33 Buprenorphine vs. Placebo for Heroin Dependence Kakko, Lancet 2003 Remaining in treatment (nr) Subjects in Control Group Died Detoxification Maintenance Treatment duration (days)

34 Medications for AUD and OUD Summary We have medications for alcohol use disorder that are helpful adjuncts to behavioral interventions Medications for opioid use disorder are essential

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