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Buprenorphine: An Introduction

Buprenorphine: An Introduction. Walter Ling MD Integrated Substance Abuse Programs UCLA Los Angeles, CA April 21 st 2006 lwalter@ucla.edu www.uclaisap.org. Buprenorphine in the Treatment of Opioid Addiction. Buprenorphine as a medication Development: Historical perspective

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Buprenorphine: An Introduction

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  1. Buprenorphine: An Introduction Walter Ling MD Integrated Substance Abuse Programs UCLA Los Angeles, CA April 21st 2006 lwalter@ucla.edu www.uclaisap.org

  2. Buprenorphine in the Treatment ofOpioid Addiction • Buprenorphine as a medication • Development: Historical perspective • Pharmacology: Safety and efficacy • Buprenorphine as a Treatment • Philosophical, societal and policy implications • The role of the clinicians

  3. Types of Addicts Correctional cases Mental defectives (degenerates) Social misfits Otherwise normal Treatment Internment camps Sterilization Vocational guidance Psychoanalysis Classification of Addicts and Recommended Treatment

  4. Forty years later :Methadone • Long acting • Orally active opiate agonist capable of reducing or eliminating withdrawal signs and symptoms • Reducing drug craving • Normalizing physiological function

  5. Not in Tx 50% 47% 40% Currently in Tx 30% No needle use since admission to Tx In Tx 5 years 23% 20% 17% 12.5% 10% 6% 0% A B C D C&D The Effect of Methadone Treatments on HIV Seropositivity Rates All subjects were male, heterosexual IV drug users in NYC. Treatment provided was methadone maintenance. Novick et al., Presented at CPDD, 1985

  6. Naltrexone

  7. Naltrexone: The Perfect Drug • Orally Effective • Rapid onset of action • Long duration of action • Safe • Few side effects • Completely blocks effects of heroin • Non-addicting • No tolerance • No dependence • No withdrawal

  8. One reason not to take naltrexone: Can’t get high!

  9. Naltrexone:The Perfect Drug “victimless cure” It’s like taking nothing.

  10. The Opioid Receptor Family

  11. Full agonist - Superagonist - fentanyl morphine/heroin hydromorphone Positive effect Potentiallylethal dose Agonist+partial agonist Partialagonist = - buprenorphine addictive potential Antagonist - naltrexone dose Negative Antagonist + agonist/partial agonist effect Mu efficacy and opiate addiction

  12. Buprenorphine as a Medication: Pharmacological Characteristics Partial Agonist • high safety profile/ceiling effect • low dependence Tight Receptor Binding • long duration of action • slow onset mild abstinence

  13. Good Effect

  14. Respiration

  15. 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Intensity of abstinence Buprenorphine Morphine 60 50 40 30 20 10 0 Himmelsbach scores Days after drug withdrawal

  16. Study # 999A: Buprenorphine’sEffect on Opiate Use Ling et al Addiction 93:475-86, 1998

  17. Buprenorphine Maintenance Treatment of Opiate Dependence: A Multicenter Randomized Clinical Trial

  18. Mean Heroin Craving: 16 week completers

  19. N remaining in treatment X N giving drug free urines Total N of subjects N remaining in treatment Joint Probability

  20. Figure A: A Comparison of Buprenorphine doses from four studies using Joint Probability

  21. A Comparison of Methadone from Four Studies Using Joint Probability

  22. Buprenorphine Made Safer:Addition of Naloxone Reduces Abuse • Naloxone will block buprenorphine’s effects by the IV but not the sublingual route • Sublingual absorption of buprenorphine @ 70%; naloxone @ 10% • If injected, BUP/NX will precipitate withdrawal in a moderately to severely dependent addict

  23. Buprenorphine made Safer:Buprenorphine/Naloxone Combination 4 part buprenorphine: 1 part naloxone Sublingual: Opiate agonist effect from buprenorphine Intravenous: Opiate antagonist effect from naloxone Discourage IV use Diminish street value Diminish diversion Allow for flexible dosing

  24. Buprenorphine as Treatment strategy:The First CTN Protocols • Inpatient detoxification: • Buprenorphine/naloxone vs clonidine • (CTN 0001) • Outpatient detoxification: • Buprenorphine/naloxone vs clonidine • (CTN 0002)

  25. Study Design Open Randomized Study Bup/Nx:Clonidine = 2:1 Buprenorphine/Naloxone 13 days detoxification Clonidine 13 days detoxification

  26. N remaining in treatment X N giving drug free urines Total N of subjects N remaining in treatment Joint Probability

  27. Percent Present and Clean0001 (Inpatient)

  28. Percent Present and Clean0002 (Outpatient)

  29. NNT: Number Needed to Treat CTN 0001 (Inpatient) • NNT for Bup/Nx 77/59 = 1.31 • NNT for Clonidine 36/8 = 4.5 NNT Clonidine : BupNx = 3.44 CTN 0002 (Outpatient) • NNT for Bup/Nx: 157/46 = 3.4 • NNT for Clonidine: 74/4 = 18.5 NNT Clonidine : Bup/Nx = 5.44 NNT= Number of patients needed to treat to achieve 1 treatment success

  30. Drug Addiction Treatment Act of 2000 An Amendment to the Controlled Substances Act(October, 2000) • Subutex and Suboxone approved October 8, 2002 and marketed in January 2003 • Qualified physicians can treat up to 30 patients with the Buprenorphine products ( sublingual tablets) • Physicians become qualified by training in sessions from designated organizations- APA, ASAM, AAAP, or over the internet; or if otherwise qualified • Physicians can treat patients in their usual medical practice setting; able to provide or refer for psychosocial treatment.

  31. Our Treatment Philosophy Addicts are sick; they need help They also sin; don’t treat them too well

  32. Treatment of Opiate Dependence • Detoxification • Maintenance

  33. Detoxification Detoxification is good for a lot of things; staying off drugs is not one of them.

  34. Pharmacotherapy and Recovery • “Medication is not recovery”? • Addiction is chemistry went wrong • You can change the brain with experience or with medication; they are the same thing

  35. How People Change • “You can change the brain with biological treatment or with behavioral treatment” • Alan Leshner, Former head NIDA • “You can change someone’s life by altering his genes; but you also do that by paying off his credit card” • James Watson

  36. Summary: Will Buprenorphine be a Success? • Not a new medication but a vehicle for a new treatment philosophy • Not just to change patients but to change us • New attitude from community leaders like us should lead to new societal attitude towards addiction and change the way we treat and view those afflicted

  37. Thanks to National Institute on Drug Abuse NIDA Clinical Trials Network Staff CTN Publications Committee Participating CTN Nodes and CTPs Reckitt Benckiser Participating Patients You the audience

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