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Buprenorphine: A Slide Set With Teaching Notes

Buprenorphine: A Slide Set With Teaching Notes. Sharon Stancliff, MD New York State Department of Health AIDS Institute A Local Performance Site of the New York/New Jersey AETC February 2004. Heroin Use: 2000.

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Buprenorphine: A Slide Set With Teaching Notes

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  1. Buprenorphine:A Slide Set With Teaching Notes Sharon Stancliff, MD New York State Department of Health AIDS Institute A Local Performance Site of the New York/New Jersey AETC February 2004

  2. Heroin Use: 2000 • 160,000 injection drug users in New York; 200,000 heroin users (estimates)- believed to be increasing in 2003 • Among those admitted into treatment over half are sniffing but transition to injection occurs for some • Transition to injection: one study found 12% over 18 months Frank MSJM 2000, Neaigus

  3. Opioids: Heroin • Use: nasal, injected, smoked and oral • Why: Euphoria, sedation, reduce pain • Negative: Dependence, overdose, injection related illnesses • Withdrawal: severe, not life threatening • Pregnancy: Withdrawal dangerous to fetus, maintain on methadone

  4. Comments • Overdose: most common when mixing drugs or after period of abstinence • Interactions with HAART • In theory ritonavir may increase potency • Analgesics are mixed with HAART Sporer 1999, Farragon, in press

  5. History of Maintenance • Prior to 1914 opiates freely available • 1914 Harrison Act: led to the end of physician ability to maintain an addiction • 1960s: redevelopment of maintenance model • 1972: FDA approval and strict regulation of methadone Joseph, 2000

  6. 2000: Drug Addiction Treatment Act • Allows for office based maintenance with schedule III, IV or V medications • Buprenorphine is the only approved medication

  7. Why was this legislation passed? • Methadone maintenance has been shown to be highly effective in reducing heroin use and the incidence of co-morbidities such as HIV • Access to methadone is limited by regulation and stigma

  8. HIV Prevention • Methadone patients are 3-6 times less likely to become HIV positive when compared to out-of-treatment heroin users, including the population that continues to use drugs. Drucker, 1998

  9. Methadone and HIV Prevention • Methadone patients report less needle and syringe sharing • Methadone patients are 3-6 times less likely to become HIV positive when compared to out-of-treatment heroin users, including the population who continues to use drugs • Buprenorphine maintenance is hoped to have a similar impact • De Castro S, 2003, Drucker 1998

  10. Methadone and the HIV+ User • Among HIV+ patients maintenance is associated with more consistent use of antiretrovirals and less hospitalizations Sambamoorthi 2000, Weber 1990, Laine 1998

  11. Further Benefits • Reductions in lethal overdose- decrease use and high tolerance • Reductions in sex work • Reductions in crime and presumably in incarceration • Sporer 1999, Metzger 1993, Drucker 1998, NIH Consensus Panel 1998

  12. Goals of Maintenance • Prevent drug withdrawal • Block the effects of heroin if taken • Prevent the powerful craving that characterizes protracted withdrawal Joseph, 2000

  13. Protracted Abstinence Syndrome • Heroin craving persists long after withdrawal is over • 80-90% of serious heroin users relapse after detox Hypothesis: opioid addiction is a metabolic illness Joseph 2000

  14. Development of Protracted Abstinence Syndrome • Genetic predisposition • Environmental factors may bring it out: use of the drug, perhaps stress or other influences • Physiological changes possibly in the receptors for endogenous opiates which are long term and probably permanent Nestler 1998

  15. Maintenance Treatment Substitution therapy: may be compared to the treatment of diabetes with insulin

  16. How Can Methadone Help? • Abstinence: given a sufficient dose virtually all heroin users will stop using heroin • Harm reduction: at lesser doses heroin use is under more control

  17. Side Effects • No known long term detrimental effects • Side effects: constipation, sweating • Longer acute withdrawal than heroin • Safe during pregnancy • Novick, Kandell

  18. Methadone Dose • Usual effective dose: 80-120 mg is required to prevent craving • Range: 5mg- >1000mg • Affected by individual differences in metabolism and by medication interactions Leavitt, MSJM 2000

  19. Length of Treatment • 80-90% of those stopping MMT will return to heroin use - a treatment, not a cure • Not predictable by life stability Magura MSJM 2000

  20. Methadone: Restricted Access • Available only in methadone clinics • Many areas lack sufficient methadone treatment slots • Many users do not enter methadone programs, probably because of the restrictions Government Accounting Office 1990, NIH Consensus Statement 1998, Institute of Medicine 1995

  21. New Federal Regulations For those who meet strict criteria • 1st 3 months: 5 days a week • 2nd 3 months: 4 days a week • 3rd 3 months: 3 days a week • 4th 3 months: 1 day a week • After 1 year: Every 2 weeks • 2 years: monthly

  22. Buprenorphine • Will be available by prescription from qualified physician offices • higher safety profile • lower anticipated street value

  23. Higher Safety Profile Difficult to overdose on buprenorphine alone • “Partial agonist”- a ceiling effect above which higher doses do not increase activity- respiratory depression unlikely • Sublingual medication- low activity if swallowed, therefore safer around children Ling 2002

  24. From Danyalearningcenter.com

  25. Lower Street Value • If used when “high” or “straight” on heroin or methadone=severe withdrawal • Mixed with naloxone (full antagonist) which is activated if injected so there is a reduced reward to opioid naïve mis-user Ling 2002

  26. Lower Street Value Effects on a person who is: • Dependent on opioid: “high” or “straight” -severe withdrawal whether taken under tongue or injected • Dependent on opioid: in withdrawal- relief • An occasional user- gets high especially if injecting but mixed with naloxone (full antagonist) which is activated if injected so reduced high Ling 2002

  27. To Prescribe Buprenorphine: • Be a qualified physician • Complete an 8 hour training Or have • Certifications: • Boarded in addiction psychiatry • ASAM certified • Boarded in addiction medicine by AOA (Or participation in buprenorphine trials)

  28. Other Physician Requirements • Register with the DEA • Register with NYS DOH (NY only) • Required to have access to appropriate psychosocial services • Limited to 30 patients per doctor (or tax ID)

  29. Induction • Patient presents in mild to moderate withdrawal • Test dose • Follow up q1-3 days to titrate up to maintenance • In-person is recommended but circumstances may vary, telephone or e-mail contact may be sufficient

  30. Maintenance • Most patients can be stabilized on 12-24mg. Because of a ceiling effect few will be on >32mg. • Some patients can dose q 2-3 days • Frequency of visits determined by MD/patient • Training encourages urine testing but it is not required by law

  31. Detoxification • 4-8 days • 4- 16mg/day: example 6-8-10-8-4 • Additional medications are usually not necessary • No particular detoxification regime has been shown to be more likely to lead to long term abstinence

  32. Side effects • Similar to other opioids: constipation, nausea, vomiting • Precipitated withdrawal in agonist dependent patient • Pregnancy category C- studies are in progress

  33. Potential medication interactions between buprenorphine and other medications • Cytochrome P450 3A4 inhibitors include: Azoles, Macrolides, Nonnucleosides and protease inhibitors • Cytochrome P450 3A4 inducers include: Phenobarbital, carbemazepine, phenytoin, rifampicin

  34. Drug Interactions • Chronic pain management : Chronic opiate agonists contraindicated- may necessitate transfer to methadone • Benzodiazepines: Increase potential for fatal overdose

  35. Which Patients? • Those in areas with limited or no access to methadone • May draw in users earlier in drug use career • Some studies suggest that buprenorphine is most useful in those who are comfortable on lower doses of methadone Barnett 2001

  36. 40 heroin users: 20 buprenophine, 20 placebo Study: Buprenorphine vs. Placebo Kakko, 2003

  37. Study: Buprenorphine vs. Methadone • 400 Pts. Randomized to flexible dose of buprenorphine (2-32 mg) or methadone(10-150mg) • Morphine positive urine: no difference • Self reported drug use: no difference • Retention: methadone somewhat greater Mattick 2003

  38. The French Experience • Licensed in 1995 by 2000 ~ 80,000 patients receiving in primary care • Dramatic decrease in heroin overdose • Physicians report significant improvement in health and social function • Misuse- some injected but double enrollment for prescription appears rare Deveaux 2002, Vignau 1998

  39. HAART-Buprenorphine Interactions • Few formal studies to date • No effect of buprenorphine on zidovudine • CYP450 3A4 Metabolism of buprenorphine would suggest possible interactions with PIs and non-nucleosides • In vitro ritonavir is potent inhibitor of BUP metabolism (ritonavir > indinavir > saquinavir). • Clinicians need to be alert for potential interactions McCance-Katz AmJ Addic 2001; Iribarne DrugMetDisp 1998;Faragon AIDS Reader 2003

  40. Buprenorphine use in HIV-infected persons: additional considerations • One study found increases in AST, ALT among pts. with hepatitis(Medians:ALT: 8.5 (-12 to 54)AST: 9.5 (-8 to 32) • 4 cases of severe hepatitis reported after injection of Buprenorphine • Possible relationship of buprenorphine to hyperlactatemia in HIV-infected persons on HAART- but small study, did not control for HCV • Petry 2000, Berson 2001, Marceau 2003

  41. Summary Buprenorphine • Moves addiction treatment into primary care • May bring patients into care before various co-morbidities have an impact • May increase use of and response to HIV treatment

  42. On-line Resources • http://www.dhs.vic.gov.au/phd/buprenorphine/ • http://www.samhsa.gov/news/click_bupe.html

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