Opioids & Buprenorphine

1. Opioids & Buprenorphine Barbara J. McGuire MD, FACP, MMM NM ACP Annual Scientific Meeting October 2010

2. Learning Objectives • To obtain a better understanding of the pathophysiology and pharmacology of opiates and opioids • To obtain a better understanding of substance abuse and dependence in NM and the US. • To understand the intent of the US Drug Abuse Treatment Act (DATA) of 2000 • To understand the therapeutic differences between methadone and buprenorphine in the treatment of opiate dependence • To learn about the pharmacology of buprenorphine as an opiate abstinence medication Barbara McGuire MD, FACP, MMM

3. Topics • The Pathophysiology of Opiate Dependence • The Scope of the Problem • Treatment Options & Trends Barbara McGuire MD, FACP, MMM

4. Definitions • Opiate = compound containing the fundamental morphine or thebaine structure possessing some affinity to any, or all, of the opioid receptor subtypes. Examples are heroin, codeine, buprenorphine and naltrexone. • Opioid = any compound, peptide or otherwise, which, while not containing the fundamental morphine or thebaine structure, possesses some affinity for any, or all, of the opioid receptor subtypes. Common opioids are endorphin, meperidine, fentanyl and methadone. Barbara McGuire MD, FACP, MMM

5. Addiction • …a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Barbara McGuire MD, FACP, MMM

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8. Substance Abuse • Any drug use that is outside of accepted medical, societal and cultural standards. Barbara McGuire MD, FACP, MMM

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16. NormalMethamphetamine Barbara McGuire MD, FACP, MMM

17. Normal Cocaine SPECT Barbara McGuire MD, FACP, MMM

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19. Normal Methadone SPECT Barbara McGuire MD, FACP, MMM

20. Physical Dependence • …a state of adaptation that often includes tolerance and is manifested by a drug class-specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Barbara McGuire MD, FACP, MMM

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22. Opioid Addiction-U.S. • Approximately 1 million+ - heroin users • Approximately 4 million+ - opioid pill users • Heroin – snort, sniff, smoking, injection • Heroin is purer and cheaper than ever • Fastest growing grp of opioid users is 15-20 year olds, many progress to heroin use • High risk for Hep B & C, HIV, TB & MRSA with injection drug use Barbara McGuire MD, FACP, MMM

23. New users of Non-Rx drugs National Survey of Drug Use and Health, 2002 Barbara McGuire MD, FACP, MMM

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26. Untreated Heroin Dependency has the highest Recidivism rate at NM Women’s Correctional Facility in Grants, NM Senate Joint Memorial 29 study from 1997-2000 Barbara McGuire MD, FACP, MMM

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30. Opiate Abstinence • Monitor Outpatient or occasionally Inpatient. Detox is less risky than EtOH • Hypertension – Rx Clonidine • Anxiety/Tremor – Rx Phenobarbital • Abdominal Pain/Cramps – Rx Bentyl • Muscle Spasm – Rx Quinine Sulfate • Pain – Rx Darvon (short acting) • Insomnia – Rx Short-acting Benzos Barbara McGuire MD, FACP, MMM

31. Treatment Options for Opiate Dependence • Abstinence - going “cold turkey” with medications to ease withdrawal symptoms • hypertension, nausea, vomiting, sweating, abdominal pain, diarrhea, tremor, lacrimation, salivation, “goose flesh”-piloerection • Methadone Treatment Program • federally regulated – liquid formulation • Buprenorphine Treatment Program • CSAT waivered physicians/programs Barbara McGuire MD, FACP, MMM

32. DATA 2000 • The Drug Addiction Treatment Act of 2000 (DATA 2000) enables qualifying physicians to receive a waiver from the special registration requirements in the Controlled Substances Act for the provision of medication-assisted opioid therapy. This waiver allows qualifying physicians to practice medication-assisted opioid addiction therapy with Schedule III, IV, or V narcotic medications specifically approved by the Food and Drug Administration (FDA). On October 8, 2002 Subutex® (buprenorphine hydrochloride) and Suboxone® tablets (buprenorphine hydrochloride and naloxone hydrochloride) received FDA approval for the treatment of opioid addiction. Barbara McGuire MD, FACP, MMM

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34. Opioid Receptors • Mu Receptors • Mu-1 – Reward & Analgesia Pathways • Mu-2 - Respiratory Suppression • Kappa Receptors • Dysphoria (Addiction & Withdrawal) • Kappa – 1, 2, 3 • Delta Receptors • Anti-depressant properties • Delta – 1, 2 Barbara McGuire MD, FACP, MMM

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38. Methadone • Schedule II narcotic • Highly addictive & Highly regulated • Easily titrated doses • Excellent pain reliever – hospice/palliative • Delivery forms– po or pr, pill-liquid-supp • Has a 24-36 hour half-life • Wholesale cost is $0.21 per 85 mg dose Barbara McGuire MD, FACP, MMM

39. Methadone vs. Buprenorphine • Methadone for the treatment of opiate dependence must be administered through a federally supervised program. • Buprenorphine may be prescribed in an office-based setting by “CSAT-waived” physicians who have completed an 8 hour training course and have received a special DEA number. Barbara McGuire MD, FACP, MMM

40. Buprenorphine • Marketed as “Subutex” (mono-drug) or “Suboxone” (bupren + naloxone), Sch III • Sublingual formulation • Binds tighter and longer to “mu” receptors in brain. Excludes other opiates. • Ideal for office-based setting, rural area • Easy to taper down over 3-6 months • Cost is about $5.50 for 8/2 mg SL pill Barbara McGuire MD, FACP, MMM

41. Buprenorphine Effect • Buprenorphine - a partial mu agonist/kappa antagonist (buprenorphine, 4 mg, sublingual) with a mu antagonist (naltrexone, 50 mg by mouth), theoretically leaves kappa antagonism as the major medication effect. • Previous studies have shown 8 mg sublingual buprenorphine to be equivalent to 60 mg oral methadone in terms of retention rate and opioid-negative urine levels. Barbara McGuire MD, FACP, MMM

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43. Scope of the Problem • NIDA-48 million (20%) of US pop has used prescription drugs for non medical reasons in their lifetime • 2004 NIDA survey of 8th, 10th, 12th graders found that 9.3% of 12th graders reported using Vicodin without a prescription in the past year & 5% reported using OxyContin in the past yr Barbara McGuire MD, FACP, MMM

44. Regulations • Drug Addiction Trtmnt Act (DATA) 2000 allows for office-based prescribing • Only physicians may prescribe - no midlevel providers allowed to Rx • Limit of 30 patients for individual docs • Large institutions-allowance is unlimited • Special DEA waiver number needed Barbara McGuire MD, FACP, MMM

45. Training Process • Physicians (only) may qualify to prescribe • Attend training course in person OR • Complete online education CD-ROM • Fill out paperwork for DEA waiver • Pay $200 to DEA for waiver registration • May prescribe immediately - if urgent • Wait for waiver number – “X-” number Barbara McGuire MD, FACP, MMM

46. Planning to Start • Design and structure your program • Educate your staff – ‘buy-in’ is essential • Create your forms: Reckitt-Ben. CD Rom • CSAT/SAMSHA website resources http://buprenorphine.samhsa.gov/ • Assistance from TIP 40 booklet http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat5.chapter.72248 Barbara McGuire MD, FACP, MMM

47. Planning to Start • Websites = suboxone.com opioiddependence.com • PCSS mentoring network • Providers in community that are willing to help new prescribing docs get started Barbara McGuire MD, FACP, MMM

48. Forms & Paperwork • Essentials • List of available pharmacies carrying buprenorphine in your area • Appropriate space & furniture for induction • Fee schedule information (? Insurance?) • Psychological services - Alternative programs • Urine testing supplies • Sign on to SAMHSA “Clinical Discussion WebBoard” for ongoing information Barbara McGuire MD, FACP, MMM

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