2. MEDICATION ASSISTED TREATMENT for OPIATE DEPENDENCY WHAT WORKS? SHELLEY ASKEW FLOYD, MS DIRECTOR OF PHARMACOTHERAPY SERVICES PYRAMID HEALTHCARE, INC. 1

3. OBJECTIVES: 1. Understanding the importance of medication assistance treatment(MAT) in a LICENSED, CERTIFIED opioid treatment program as a viable strategy to overdose prevention 2. Provide current listing of opioid treatment options available 3. Present challenges and benefits of each 2

4. Pharmacotherapy~ The combined use of medication and psychotherapy in a treatment facility. Why is this important?- medication complements psychosocial supports/therapy by quieting the brain so counseling can work without the need of the dependent drug… 3

5. Who regulates methadone treatment facilities:  Substance Abuse and Mental Health Services Administration (SAMHSA)  Drug Enforcement Agency  Department of Drug & Alcohol Programs -PA Chapter 715  Accreditation Entities (i.e.CARF, JCAHO) 4

6. History of MAT  Late 19 th - Early 20 th Century  Public perceptions was that Addiction WAS NOT A DISEASE  Saw increased use in 1950’s and 1960’s (morphine/heroin)  Early 1970’s Addiction IS A DISEASE  Methadone treatment in OTP begins 5

7. SO WHAT DO WE WANT? 6

8. Effective medication assisted treatment has the following desired outcomes: ~ Prevention of the onset of subjective/objective signs of opioid abstinence syndrome for at least 24 hours (post acute withdrawal) ~Reduction or elimination of drug craving routinely experienced by the patient ~Blockage of the euphoric effects of any illicitly acquired self administered drug without the patient experiencing or observers noticing undesirable effects 7

9. WHAT ARE THE CHOICES? Traditional agonist therapy medications Methadone & Buprenorphine AND Naltrexone Antagonist therapy medication 8

10. WHAT IS THE DIFFERENCE? 9

11. Agonist-a chemical that binds to a receptor and activates the receptor in the same way as opioid drugs. Partial Agonist-activate receptors by stimulating the dopamine reward pathway. Antagonist-binds to opioid receptors but rather than producing an effect, they block the effects of opioids. 10

12. Methadone (Full opioid agonist)-never formally approved by the FDA but most commonly used for treatment Buprenorphine (Partial agonist)- Two formulas containing buprenorphine were approved by the FDA for use in the US in Oct 2000. Subutex® (buprenorphine only) and buprenorphine w/naloxone (Suboxone®). Both can be prescribed in a certified physician’s office and now in a LICENSED, CERTIFIED ClINIC Naltrexone(Antagonist)- Revia® approved in 1984. Vivitrol® was first approved by the FDA for the treatment of alcohol dependence 2006. It received subsequent approval by the FDA for the use of opioid treatment in Oct 2010. 11

13. HOW DO YOU CHOOSE? H 12

14. The first couple of weeks after opioid detox is the most vulnerable period for relapse and overdose. No 1 shop fits all in the treatment of opioid dependence. The intervention must fit individual need based on: -Symptoms -Length of dependence -Medical History & complexities -Setting/location of the program -Individual ability & desire to change 13

15. GUIDELINES FOR CONSIDERATION 14

16. Consider Methadone first when: History of addiction is severe to moderate > 18-24 months ~Current physiologically dependence and at least one year prior physiologically dependent ~2 documented attempts at short term treatment within 12 months prior to seeking admission ~Pregnant (physiologic dependency requirement waived)- current standard of care ~Inadequate psychosocial or recovery supports, e.g. safe and stable housing, supportive family, employed/in school, etc. 15

17. Methadone Continued: ~Recent documented overdose ~Recently released from prison/jail environment with history of MAT treatment prior to incarceration ~Not successful in adhering to Buprenorphine treatment program requirements ~Age 18 years and above 16

18. Methadone continued: Benefits: ~ Used for the treatment of pain ~Highly regulated in OTP’s ~Daily monitoring with gradual “freedom” (take homes) Drawbacks: ~Narcotic ~Can be addictive physiologically and/or physically ~Precipitated withdrawal if discontinued abruptly ~Drug interactions 17

19. Consider Buprenorphine first History of addiction moderate to mild > 12-18 months ~Unable to access a methadone treatment clinic or difficulty adhering to scheduled hours for dosing ~Documented severe, uncontrollable adverse effect or true hypersensitivity to methadone ~Not dependent or abusing Central Nervous System (CNS) depressants, including benzodiazepines and alcohol 18

20. Buprenorphine continued: ~Does not have a history of multiple treatment attempts and relapses, except those with multiple detox attempts and relapses ~Mental health disorder, if present, is stable, e.g.” no emotional, behavioral or cognitive conditions that would complicate treatment ~ 19

21. Buprenorphine continued: ~No prior adverse reactions to buprenorphine or naloxone or taking medications that might adversely interact ~Pregnant women may be good candidates (not label indicated) ~Age 16 years and above 20

22. Buprenorphine continued: Benefits: - More conducive to an engaged lifestyle -Most insurances cover medication and counseling -Counseling requirements Drawbacks: -Diversion issues -Multiple doses -Minimum oversight -Counseling requirements -Payer requirements 21

23. Consider Vivitrol® when: History of addiction mild or special populations < 12-18 months ~Not interested in methadone or buprenorphine ~Abstinent from opioids 7-10 days prior ~Recovery environment/psychosocial circumstances sufficiently supportive and stable ~ Mental health disorder, if present, is stable, e.g.” no emotional, behavioral or cognitive conditions that would complicate treatment 22

24. Vivitrol® continued: ~Exclude acute hepatitis or liver failure ~Not dependent on or abusing Central Nervous System (CNS) depressants, including benzodiazepines and alcohol ~Easier to use in residential settings after detox from opioid Benefits: ~Monthly injection ~Non-addictive ~Not a narcotic ~Will not precipitate withdrawal when discontinued 23

25. Vivitrol® continued: Draw backs: ~Strongest effects are in the first three weeks ~Must be opioid free for 7-10 days ~Individuals transitioning from buprenorphine or methadone may be vulnerable to precipitated withdrawal up to two weeks ~Cost $800-$1000 per monthly injection 24

26. As cute as he may be….he is still there 25

27. Benzodiazepine use in MAT If an individual is benzodiazepine dependent, consider detoxification first and/or work with prescriber for consideration of alternative medications/ approaches. 26

28. Challenges to MAT: ~Profit motives ~ Harm Reduction vs. Drug Free models ~Diversion issues ~Individual not consistently taking medication ~Individual not participating in therapy ~Medical complications ~Stigma- “drug replacement therapy” ~LIFE-no treatment option is guaranteed! 27

29. MAT should continue as long as the patient desires and derives benefit from treatment. There should be no fixed length of time in treatment. 28

30. …resolution with a final result. Webster dictionary defines that as completion or in the world of addiction a CURE. We haven’t gotten there yet! Therefore, an individual may need multiple attempts to get it right as different stressors (or even the same stressors as before treatment) may return. 29

31. WITHOUT TREATMENT WE HAVE ZERO CHANCE AT RECOVERY & PREVENTION!!! I BELIEVE IT IS SAFE TO SAY-WE HAVE WITNESSED THE ALTERNATIVE! 30

32. PYRAMID HEALTHCARE, INC. offers MAT in the following locations: Pyramid Pittsburgh Outpatient (Suboxone®/Methadone), Pyramid Pittsburgh Inpatient/Detox (Suboxone®/Methadone) Pyramid Southside Outpatient (Suboxone®/Vivitrol) Foundations Medical Services, LLC (Methadone/Suboxone®*) Pyramid Dolminis (Methadone) Altoona Outpatient (Suboxone®/Vivitrol®**) Duncansville Inpatient/Detox(Suboxone®/Vivitrol®/Methadone) Chambersburg Outpatient (Suboxone®) York Pharmacotherapy Services (Suboxone®/Methadone) Today Inc. Inpatient (Vivitrol®) *-Self pay only **-Must be started in inpatient first 31

33. Coming Soon: Allentown Outpatient (Suboxone®/Vivitrol®) Hillside (Vivitrol®) Call 1-888-694-9996 FOR MORE INFORMATION & REFFERAL 32

34. References: Substance Abuse and Mental Health Services Administration (SAMHSA) website, about medication assisted treatment http://www.dpt.samsha./gov SAMHSA Treatment Improvement Protocol #43 & #40 Community Care Behavioral Health decision tool algorithm on the use of medication assisted treatment Alkermes prescribing information packet for Vivitrol® Federal Guidelines for Opioid Treatment Programs http://www.dpt.samsha./gov 33

35. THANK YOU & QUESTIONS 34