Overview of Medications to Treat Addiction in Primary Care

1. OVERVIEW OF MEDICATIONS TO TREAT ADDICTION IN PRIMARY CARE Prepared by CASAColumbia® February 2014

2. Outline • Introduction • Addiction Involving: − Tobacco/Nicotine − Alcohol − Opioids − Other Drugs • Further Considerations © CASAColumbia 2014 2

3. INTRODUCTION © CASAColumbia 2014 3

4. Addiction For background information on addiction Addiction Medicine: Closing the Gap between Science and Practice1 © CASAColumbia 2014 4

5. Addiction For information on screening, diagnosis, treatment planning & management Overview of Addiction Medicine for Primary Care2 (62 Slides) Overview of Addiction Medicine for Primary Care: Supplement3 (30 Pages) © CASAColumbia 2014 5

6. Stabilization • Withdrawal in some cases can be lifethreatening • Medical management for stabilization/detoxification may be required • Details for these topics can be found on Pages 88-92 of the CASAColumbia® report Addiction Medicine: Closing the Gap between Science and Practice1 © CASAColumbia 2014 6

7. Addiction Treatment • Treat addiction as a primary disease • Address tobacco/nicotine, alcohol & other drugs • Manage co-occurring disorders dopamine transporters © CASAColumbia 2014 7

8. Combined Treatment • Medications & psychosocial therapies • Can increase retention in treatment • Can decrease relapse rates © CASAColumbia 2014 8

9. Combined Treatment • To achieve the best results medications should be combined with psychosocial therapies • Research studies illustrate the effectiveness of various combinations of treatment4-6 • Details for psychosocial therapies can be found on Pages 102-106 of the CASAColumbia® report Addiction Medicine: Closing the Gap between Science and Practice1 © CASAColumbia 2014 9

10. Specialist Referral Consider for Complex Cases • Addiction medicine physicians find a doctor near you • Addiction psychiatrists find a doctor near you Addiction medicine physician: http://www.abam.net/find-a-doctor Addiction psychiatrist: https://application.abpn.com/verifycert/verifyCert.asp?a=4 © CASAColumbia 2014 10

11. ADDICTION INVOLVING TOBACCO/NICOTINE © CASAColumbia 2014 11

12. FDA-Approved Meds Tobacco/Nicotine • varenicline (Chantix) • bupropion (Zyban, Wellbutrin) • nicotine replacement therapy (e.g., patch, gum, lozenge, inhaler, nasal spray) • combinations • combine with psychosocial therapies © CASAColumbia 2014 12

13. varenicline (Chantix) • 3X higher odds of smoking cessation7 • Nicotinic acetylcholine receptor partial agonist8 • Superior to bupropion & single-form nicotine replacement therapy9 © CASAColumbia 2014 13

14. varenicline (Chantix) • Begin 1wk prior to target quit date • Starting dose 0.5mg QD x 3dy • Up to 1mg BID x 12wk extension of 12wk © CASAColumbia 2014 14

15. varenicline (Chantix) • Black Box Warning: neuropsychiatric events • Common Side Effects: headache, insomnia, nausea, abnormal dreams • FDA Warning: increased risk of CV events in patients with known CVD • Meta-analyses show no increased risk of neuropsychiatric events9 or cardiac events9-10 © CASAColumbia 2014 15

16. bupropion (Zyban, Wellbutrin) • 2X higher odds of smoking cessation11 • Inhibits norepinephrine & dopamine uptake12 © CASAColumbia 2014 16

17. bupropion (Zyban, Wellbutrin) • Begin 1wk prior to target quit date • Starting dose 150mg QD x 3dy • Up to 150mg BID x 7-12wk extension of 12wk © CASAColumbia 2014 17

18. bupropion (Zyban, Wellbutrin) • Black Box Warning: neuropsychiatric events • Contraindications: seizure disorder / predisposition; abrupt cessation of alcohol / sedatives; risky use / addiction involving alcohol • Common Side Effects: insomnia, tachycardia, weight loss, headache, lower seizure threshold • Meta-analysis shows no increased risk of neuropsychiatric events9 © CASAColumbia 2014 18

19. nicotine replacement (Nicoderm, Nicorette, Commit, Nicotrol) • 1.5X to 2X higher odds of smoking cessation13 • Nicotine without exposure to other toxins © CASAColumbia 2014 19

20. nicotine replacement (Nicoderm, Nicorette, Commit, Nicotrol) • Contraindications: severe angina, postmyocardial infarction, pregnancy, hypersensitivity • Side Effects: minimal except nasal spray (local irritation, cough, headache, dyspepsia) • Combination long-acting (e.g., patch) & shortacting (e.g., gum) better than single form13 © CASAColumbia 2014 20

21. nicotine replacement (Nicoderm, Nicorette, Commit, Nicotrol) Dosing for 1 cigarette 1mg of nicotine • Patch (OTC): 7/14/21mg, q12-24hr, 8wk taper • Gum (OTC): 2/4mg, q1-2hr, 3mo taper • Lozenge (OTC): 2/4mg, q1-2hr, 3mo taper • Inhaler (Rx): 6-16 cartridges, q24hr, 3-6mo taper • Nasal Spray (Rx): 1-2 sprays, q1hr, 3-6mo taper © CASAColumbia 2014 21

22. nicotine replacement (Nicoderm, Nicorette, Commit, Nicotrol) Delivery method characteristics • Patch (OTC): only long-acting method • Gum (OTC): “chew & park” technique crucial; should not be used with acidic food or liquids • Inhaler (Rx): beneficial for behavioral rituals • Nasal Spray (Rx): fastest absorption, most side effects © CASAColumbia 2014 22

23. ADDICTION INVOLVING ALCOHOL © CASAColumbia 2014 23

24. FDA-Approved Meds Alcohol • acamprosate (Campral) • disulfiram (Antabuse) • naltrexone (ReVia, Depade, Vivitrol) • combine with psychosocial therapies © CASAColumbia 2014 24

25. acamprosate (Campral) • Improves abstinence & treatment retention14 • May modulate glutamate & GABA15 © CASAColumbia 2014 25

26. acamprosate (Campral) • Begin once abstinent for >24hr if possible • Dose at 666mg TID x 6mo • Safe even with severe hepatic disease • Contraindication: severe renal disease • Common Side Effects: diarrhea, fatigue © CASAColumbia 2014 26

27. disulfiram (Antabuse) • Best efficacy with routine use in monitored systems given high rates of noncompliance16 • Aldehyde dehydrogenase inhibitor © CASAColumbia 2014 27

28. disulfiram (Antabuse) • Causes diaphoresis, headache, dyspnea, hypotension, palpitations, nausea, vomiting (when using alcohol) • Monitoring by spouse, supervisor, etc. is highly recommended © CASAColumbia 2014 28

29. disulfiram (Antabuse) • Starting dose: 250-500mg QD x 1-2wk • Maintenance dose: 125-500mg QD x 6mo • Clinicians often start & maintain at 250mg QD • Remains active 14 days after discontinuation • Contraindications: severe myocardial occlusive disease, psychosis, hypersensitivity • Side Effects: hepatitis, psychosis © CASAColumbia 2014 29

30. naltrexone (ReVia, Depade, Vivitrol) • Decreases drinking by 83% over placebo17 • FDA-approved for alcohol or opioids • Mu opioid receptor inhibitor • Genetic factors affect efficacy © CASAColumbia 2014 30

31. naltrexone (ReVia, Depade, Vivitrol) • Only begin after abstinence from opioids >7dy • Starting oral dose 25mg QD (Day 1), 50mg QD (Day 2) • Maintenance oral dose 50mg QD x 6mo • Depot dose 380mg IM q4wk: better compliance • Trial of at least 3mo recommended © CASAColumbia 2014 31

32. naltrexone (ReVia, Depade, Vivitrol) • Black Box Warning: hepatotoxicity • Contraindications: acute hepatitis, liver failure, prescribed opioids • Side Effects: headache, GI distress, syncope, LFT elevation • Literature review suggests no increased risk for causing or worsening hepatic disease18-19 © CASAColumbia 2014 32

33. ADDICTION INVOLVING OPIOIDS © CASAColumbia 2014 33

34. FDA-Approved Meds Opioids • buprenorphine/naloxone (Subutex, Suboxone, Zubsolv) • methadone (Methadose) • naltrexone (ReVia, Depade, Vivitrol)* • combine with psychosocial therapies * details for naltrexone included on previous slides for addiction involving alcohol © CASAColumbia 2014 34

35. buprenorphine/naloxone (Subutex, Suboxone, Zubsolv) • Reduced use & better treatment retention20 • Partial opioid agonist + opioid antagonist • Exercise caution in quantities prescribed per visit due to potential for misuse • Special training required in order to prescribe • See details under section “For Physicians” at buprenorphine.samhsa.gov © CASAColumbia 2014 35

36. buprenorphine/naloxone (Subutex, Suboxone, Zubsolv) • Starting dose 8mg QD (Day 1) 16mg QD (Day 2-3) • Maintenance dose 12-16mg QD • Contraindication: hypersensitivity • Side Effects: respiratory depression, headache, pain, insomnia, GI symptoms © CASAColumbia 2014 36

37. methadone (Methadose) • Reduced use & better treatment retention21 • Long-acting opioid agonist • Distributed only by licensed facilities © CASAColumbia 2014 37

38. methadone (Methadose) • Starting dose 20-40mg QD • Maintenance dose 80-120mg QD • Dose may be less depending on baseline opioid use • Must follow licensed facility protocol, e.g., EKGs © CASAColumbia 2014 38

39. methadone (Methadose) • Contraindications: respiratory depression, severe asthma, ileus, hypersensitivity • Side Effects: QT prolongation, respiratory depression © CASAColumbia 2014 39

41. FDA-Approved Meds Other Drugs • Currently no FDA-approved medications for addiction involving other drugs • Research & development ongoing for marijuana, cocaine, others • Combine with psychosocial therapies © CASAColumbia 2014 41

43. For Prescription Drugs Always consider risks of addiction if prescribing • Opioids • Benzodiazepines • Stimulants • Other addictive prescription drugs © CASAColumbia 2014 43

44. For Adolescent Patients • Only buprenorphine/naloxone is FDA-approved for 16 years & older • All other medications are FDA-approved for 18 years & older • Adolescent treatment should focus more on psychosocial therapies © CASAColumbia 2014 44

45. For Elderly Patients • Monitor for drug-drug interactions • For renal insufficiency adjust dosing of varenicline, bupropion, acamprosate, methadone • For hepatic insufficiency adjust dosing of bupropion, buprenorphine/naloxone, methadone, naltrexone (contraindication if severe) © CASAColumbia 2014 45

46. References 1. CASAColumbia. Addiction medicine: closing the gap between science and practice. 2012 Jun. http://www.casacolumbia.org/addiction-research/reports/addiction-medicine 2. CASAColumbia. Addiction medicine: primary care clinical guide. 2013 Aug. http://www.casacolumbia.org/health-careproviders/guide 3. CASAColumbia. Addiction medicine: primary care clinical guide supplement. 2013 Aug. http://www.casacolumbia.org/health-careproviders/guide-supplement 4. Amato L, et al. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD005031. 5. Anton RF, et al. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005 Aug;25(4):349-57. 6. Feeney GF, et al. Cognitive behavioural therapy combined with the relapse-prevention medication acamprosate: are short-term treatment outcomes for alcohol dependence improved? Aust N Z J Psychiatry. 2002 Oct;36(5):622-8. 7. Fiore MC, et al. Clinical practice guideline. Treating tobacco use and dependence: 2008 update. U.S. Department of Health and Human Services, 2008 May. 8. U.S. Food and Drug Administration. Highlights of prescribing information for Chantix (varenicline). 2013 Feb. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021928s030lbl.pdf 9. Cahill K, et al. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2013 May 31;5:CD009329. 10. Prochaska JJ, et al. Risk of cardiovascular serious adverse events associated with varenicline use for tobacco cessation: systematic review and meta-analysis. BMJ 2012; 344:e2856. © CASAColumbia 2014 46

47. References 11. Hughes JR, et al. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD000031. 12. U.S. Food and Drug Administration. Prescribing information: Zyban (bupropion hydrochloride). 2012 Jan. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020711s036lbl.pdf 13. Stead LF, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2012 Nov 14;11:CD000146. 14. Rösner S, et al. Acamprosate for alcohol dependence. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD004332. 15. U.S. Food and Drug Administration. Highlights of prescribing information for Campral (acamprosate calcium). 2012 Jan. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021431s015lbl.pdf 16. Laaksonen E, et al. A randomized, multicentre, open-label, comparative trial of disulfiram, naltrexone and acamprosate in the treatment of alcohol dependence. Alcohol Alcohol. 2008 Jan-Feb;43(1):53-61. 17. Rösner S, et al. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD001867. 18. Brewer C, et al. Naltrexone: report of lack of hepatotoxicity in acute viral hepatitis, with a review of the literature. Addict Biol. 2004 Mar;9(1):81-7. 19. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. Naltrexone: LiverTox Clinical and Research Information on Drug-Induced Liver Injury. http://livertox.nih.gov/Naltrexone.htm 20. Mattick RP, et al. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD002207. 21. Mattick RP, et al. Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD002209. © CASAColumbia 2014 47

48. Acknowledgements • Margot Cohen contributed much of the research and writing for these materials. • The following subject-matter experts served as external reviewers for these materials: Kevin Kunz, M.D., M.P.H., Frances Levin, M.D., Charles O’Brien, M.D., Ph.D. • Funding was provided by The Joseph A. Califano, Jr. Institute for Applied Policy. © CASAColumbia 2014 48

49. Ending Addiction Changes Everything www.casacolumbia.org

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