Medication Assisted Treatment of Opioid Use Disorders

1. Medication Assisted Treatment of Opioid Use Disorders Perspectives, Pearls & Pitfalls Kent L. Davis MD 12/13/2018

2. “Deaths from opioid drug overdoses have hit an all-time record in the U.S.” Centers for Disease Control and Prevention Press Release 12/18/2015

3. Drug overdoses are now the leading cause of death among Americans under 50. New York Times 6/5/2017

5. 1565 deaths from drug overdoses, compared to 782 motor vehicle fatalities, were reported in Kentucky in 2017

6. Kentucky Overdose Death Rates 1999---8.3/100,000 2002---20.8/100,000 2010---22.9/100,000 2016---33.0/100,000

7. Kochanek KD, et al. National Vital Statistics Report 2011;60:1-117. CDC Vital Signs. Prescription Painkiller Overdoses. Use and abuse of methadone as a painkiller. 2012. Warner M, et al. Drug poisoning deaths in the United States, 1980-2008. NCHS data brief, no 81. Hyattsville, MD: National Center for Health Statistics. 2011. National Center for Injury Prevention and Control. Division of Unintentional Injury Prevention. Policy Impact. Prescription PainkillerOverdoses. Nov 2011.

8. Rate of Unintentional Drug Overdose Deaths: United States 1970-2015

9. Opioids • Americans constitute 4.6% of the world’s population but consume 80% of world’s opioid supply • Americans consume 99% of the world’s hydrocodone • In 2016, U.S. healthcare providers wrote 236 million prescriptions for opioid painkillers.

11. Morphine Heroin

13. Circuits Involved In Drug Abuse and Addiction All of these brain regions must be considered in developing strategies to effectively treat addiction

14. Opioid Use Disorder per DSM 5 1. Impaired control: (1) taking more or for longer than intended, (2) unsuccessful efforts to stop or cut down use, (3) spending a great deal of time obtaining, using, or recovering from use, (4) craving for substance.
2. Social impairment: (5) failure to fulfill major obligations due to use, (6) continued use despite problems caused or exacerbated by use, (7) important activities given up or reduced because of substance use. 
3. Risky use: (8) recurrent use in hazardous situations, (9) continued use despite physical or psychological problems that are caused or exacerbated by substance use.
4. Pharmacologic dependence: (10) tolerance to effects of the substance, (11) withdrawal symptoms when not using or using less.*

15. “All treatments work for Some people/patients” “No one treatment works for All people/patients” Alan I. Leshner, Ph.D (Former Director NIDA)

16. Extended Abstinence is Predictive of Sustained Recovery After 5 years – if you are sober, you probably will stay that way. It takes a year of abstinence before less than half relapse Dennis et al, Eval Rev, 2007

17. “Essential Ingredients”to Long Term Recovery Maintenance • Contingency management-provide positive and negative consequences regarding compliance with treatment • Frequent random drug testing-accountability • Tight linkage with the 12-step programs and the complete abstinence defined by them • Active management of relapses by intensified treatment and monitoring • Continued care approach • Focus on lifelong recovery

18. Essential Services

19. Medications

20. Mu Opioid Receptor

21. Methadone -Developed in Germany (1937) then introduced into the United States (1947) as an analgesic --FDA approved in 1972 for treatment of opioid “addiction” --Studies confirm that when used as a treatment • Health and productivity improve • Decrease criminal activity • Decrease needle sharing • Decrease risky sexual behavior

22. Naltrexone 1984-Approved by FDA for opioid dependence Complete antagonist ReVia (oral tablet) Vivitrol (sustained released injection approved by FDA in 2010)

23. Drug Addiction Treatment ActDATA-2000 Sponsored by Senators Biden, Hatch And Levin Signed into law by President Clinton October, 2000 Cleared the way for FDA approval of Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) in October, 2002 “Qualified” physicians allowed to prescribe 30 patients in the first year then 100 patients thereafter Comprehensive Addiction and Recovery Act (CARA) was signed into law 7/22/2016 and raised the limit to 275 patients for qualified prescribers

24. Buprenorphine • Partial opioid agonist approved in 2002 by FDA specifically for the treatment of opioid dependence • Number of buprenorphine prescriptions dispensed through retail pharmacies reached 12.5 million in the twelve months ending June 30, 2016 • Studies show significant improvement from baseline in --Illicit drug use --Criminal activity --Employment --Personal relationships

25. Buprenorphine • Partial agonist/low intrinsic activity • High affinity for mu and kappa receptor • Slow dissociation (prolonged half life of 24-60 hours)

26. Buprenorphine • Advantages • Prescriptions provided in the privacy of a physician’s office • Less risk of respiratory depression/overdose • Less sense of euphoria • Less cognitive deficits

27. Buprenorphine • Disadvantages • “Partial agonist” is not suitable for more severe disease • Poor oral absorption • Can & will be diverted • Removes the “incentive” to engage in the process of moving from “addictive thinking/behavior” to “recovery thinking/behavior”

29. Hazelden Betty Ford Foundation • Hazelden was founded in 1949 • Developed the Minnesota Model of abstinence treatment of substance use disorders based on Alcoholic’s Anonymous 12 steps • Merged with Betty Ford Foundation (founded in 1982) in 2014

30. COR-12 Pathways

31. COR-12: Center City Patient Participation

32. COR-12 Results Atypical Discharges (Center City)

33. Naloxone • Community-base overdose education and naloxone distribution (OEND programs) • As of July 2014, at least 644 sites were in existence in the U.S. • Project Lazarus • Kentucky SB 192 • Routes of administration: IV, IM, SC, Intranasal

34. What is Recovery

35. 10 Guiding Principles of Recovery

36. We will not reduce the unacceptable numbers of overdose deaths from prescription opioids and, increasingly, heroin, without realizing that addiction—and failure to treat it—lies at the heart of the problem. Nora Volkow, M.D. NIDA Director March 2015