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Addiction Pharmacotherapies in Integrated Systems OPIOIDS

Addiction Pharmacotherapies in Integrated Systems OPIOIDS. Univ. Prof. Dr. Gabriele Fischer Department of Psychiatry Addiction clinic Medical University Vienna DELIVERY SYSTEMS FOR SUBSTANCE ABUSE TREATMENT Istanbul September 5th-7th, 2005. Morphine dependence (DSM IV 304.0).

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Addiction Pharmacotherapies in Integrated Systems OPIOIDS

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  1. Addiction Pharmacotherapies in Integrated SystemsOPIOIDS Univ. Prof. Dr. Gabriele Fischer Department of Psychiatry Addiction clinic Medical University Vienna DELIVERY SYSTEMS FOR SUBSTANCE ABUSE TREATMENT Istanbul September 5th-7th, 2005

  2. Morphine dependence(DSM IV 304.0) Prevalence: 0.6-0.9% in Europe (UNODC; 2004) 13 times higher mortality compared to a matched age-group (predominantly young men) 75% Hepatitis C High comorbidity with affective disorders (> 50%) 25% are in a treatment system Women have a lower retention rate: Higher psychiatric comorbidity - mood disorders, PTSD Higher amount of opoid receptors Higher stigma Fluctuation of the staff Decision making: male system

  3. Science „Addiction is a brain disease and it matters“ .......The most effective treatment approach, as in many psychiatric diseases, includes biological, behavioral and social-context treatment approaches .... ......Addiction is a chronic relapsing disorder.........

  4. Relapse Rates following treatment O’Brien & McLellan, 1996, The Lancet

  5. Relapse Rates Are Similar for Drug Dependence andOther Chronic Illnesses 50 to 70% 50 to 70% 30 to 50% 100 90 80 70 60 Percent of Patients Who Relapse 50 40 to 60% 40 30 20 10 0 Drug Dependence Type I Diabetes Hypertension Asthma Source: McLellan, A.T. et al., JAMA, Vol 284(13), October 4, 2000.

  6. Structure Office based prescription versus specialized clinics Why Maintenance in opioid dependence ? Why detoxification ? Why Methadone ? Why some other opioid medication ? Buprenorphine, LAAM, SR-morphine

  7. Advantages: multidisciplinary Psychiatrist Pharmacist Nurses Psychologist Social worker Disadvantages High treshold - selected group Centralized in large cities Limited capacity Expensive Stigma-“addiction“ clinic Specialist clinic • Adolescents • Pregnancy

  8. Advantages „family doctor“- prevention & early treatment initiation Low treshold More capacity Decentralized Cost effective Integration into mainstream Drug-drug interaction Disadvantages Limited psychiatric education - comorbidity Time for education Lack of support through specialised clinics General practitioner

  9. Modell: Vienna University/General Hospital Vienna SPECIAL PROGRAMME: PREGNANCY, Adolecents Hepatitis, HIV Prison Local pharmacy ADDICTION CLINIC visits: 1-7 times a week Clinical pharmacist psychiatrists socialworkers psychologists nurses AKH: All inpatient with addiction GP`S

  10. Information about Austria(8 MIO inhabitants) 50 000 opioid dependent subjects 6 400 are in opioid maintenance treatment Vienna Vienna: 1.8 mio inhabitants Around 25 000 opioid dependent subjects > 4000 in opioid maintenance: 2/3 in GP`s offices All GP`s can prescribe opioids, who are registered for treatment 239 community pharmacies provide maintenance treatment Majority of opioid narcotic prescriptions are placed in pharmacies HIV/AIDS: around 9000 infected; total 2418 Aids pat. - died: 1394

  11. How many GP`s treat opiate addicts in Vienna • Around 200 GP`s • Per visit around 20 EURO • Continious education - 4 times a year • Few 2 - 3 • Majority 30 - 40 • Some 100 • Few > 250

  12. Ortner et al; EAR 2004; 10: 105-111; Buprenorphine maintenance: office - based treatment with Addiction support Addiction Clinic GPs 100% 80% 60% 40% 20% 0% Week 15 Week 03 Week 01 Week 05 Week 07 Week 11 Week 13 Week 02 Week 09 Induction

  13. Urinetoxicology Addiction Clinic GPs % positive urinetoxicology

  14. Mean Dose of Buprenorphine Addiction Clinic GPs 20 18 16 14 12 Buprenorphine (mg) 10 8 6 4 2 0 Week Week Week Week Week Week Week Week 01/d1 01/d3 02/d1 03/d1 05 07 11 13

  15. Organisation of maintenance treatment in the European Union • General practitioner’s: • Austria, Belgium, France (buprenorphine), Germany, Ireland, Luxembourg, UK • Specialised centres: • Denmark, France (methadone), Italy, the Netherlands, Portugal, Spain • Specialised centre - limited number: • Finland, Greece, Sweden, Norway • “New member states” • Specialised clinics - still in some countries “monopol”

  16. Opiate detoxification: What are the goals ?Charles O`Brian, Addiction 100:1035; 2005 Ultra-rapid, rapid, intermediate and long-term detoxification Different medication methadone, clonidine, lofexidine, morphine, neuroleptics, buprenorphine, buprenorphine/naloxone “psychosocial support ?”

  17. Sees at al; 2000 Methadone maintenance therapy vs 180-day psychsocially enriched methadone detoxification for treatment of opioid dependence

  18. 1-year retention & social function after buprenorphine-assisted relapse prevention...: randomised, placebo-controlled trial Kakoo, et al, The Lancet, 2003 4 people died in placebo controll Group (with psychosocial support)

  19. Relapse and mortality after opioid detoxificationStrang et al., BMJ 2003 High Mortality: • Patients, who finished successfully 28 day detoxification • Patients, who remained longer in-patient • High comorbidity • After prison discharge Who survived ? Patients who discontinued detoxification treatment

  20. State-of-the-art: Maintenance therapy with opioids • Naltrexone • Methadone • Buprenorphine • Buprenorphine/Naloxone • Buprenorphine - Depot • LAAM • Oral slow-release Morphine • Codeine • Heroin

  21. Treatment works Vincent Dole, 1965 • Methadone: • Mu-agonist • Plasma half-life: 24 hours • BUT: poor metabolizers • fast metabolizers • concomitant medication • racemic version • Solutions for daily supervised • intake

  22. Molecule

  23. Buprenorphine: will it succeed? • Pharmacological advantages • Safety, efficacy and long duration of action - up to 72 hours • Clinical advantages • High patients acceptance, low abuse potential • Logistic advantages • Multiple settings of delivery • Political and social congruence

  24. A contolled trial of daily versus thrice-weekly buprenorphine admnistration for the treatment of opiate dependencePerez de los Cobos J et.al., SpainDrug and Alcohol Dependence (2000) 59(3):223-33 • Design: double-blind, double- dummy, parallel 12 week-trial (n = 60) daily n=30, thrice-weekly n=30) • Retention: daily dosing 88 % thrice-weekly 82 % • Final doses: 8 mg/ daily 16-16-24 mg/ thrice-weekly buprenorpine • Opioid urinalysis: pos. 58,5 % thrice-weekly vs. 46,6 % daily administration • Result: Both design are equivalent in retention, but significant lower opioid pos. urinetoxicology in daily intake of buprenorphine.

  25. PET

  26. Buprenorphine literature searchUS/Europe/Australia There are differences: Up 2001 all US publications refer to buprenorphine applied in a solution - the registered substance is - a sublingual tablet - different bioavailability

  27. Therapy of opioid dependence in GP`s offices NEJM, 2002: Fiellin et al: Office - based treatment with buprenorphine NEJM, 2003: Fudala et al, 2003: Office based treatment of opiate addiction with buprenorphine-naloxone

  28. BUPRENORPHINE/ NALOXONE FOR MAINTENANCE & DETOXIFICATION THERAPY SUBOXONE®: Sublingualtablets Buprenorphine : Naloxone: Ratio 2 mg: 0.5 mg Ratio 8 mg: 2 mg Ling W., et al: National Institute on Drug Abuse Clinical Trial Network Addiction 100: 1090-1110, 2005

  29. Buprenorphine-Depot Evaluation of an injecting depot formulation of buprenorphine: placebo comparison; Sigmon et al., 2004 Addiction Depot formulations: will pharmacological advances improve treatment options and outcomes for substance abusers? Petry, Addiction 2004 Controversial discussion

  30. Cochrane reviews on opioid maintenance therapy (RCT) • Clark et al: 2003, Faggiano et al: 2003, Ferri et al: 2003 Mattick et al: 2003, Mattick et al: 2004 Out come parameter • Retentionrate • Concomitant consumption (heroin, cocaine, benzodiazepine)

  31. Results: Cochrane review on opioid maintenance therapy (RCT) • 12 075 Participants, mean length: 32 weeks; Meth & Bup & LAAM • 32 USA, 13 Europe, 5 Australia, 2 Asia • Methadone • Is the most effective substance in regard to retention and reduced concomitant consumption of heroin • Higher dosing provides better outcome

  32. Retention: LAAM/METHADONE/BUPRENORPHINE

  33. Retention: LAAM/METHADON/BUPRENORPHIN - Naltrexon

  34. LAAM

  35. Levo-alpha-acethylmethadol (LAAM) versus methdone: treatment retention and opiate useLongshore D, Annon J, Anglin MD, Rawson RAddiction 100: 1131-1139 • No difference in treatment retention (75,5% vs 77%) after 26 weeks (mean dosing: LAAM: 77.5 mg, M: 67,4 mg • LAAM patients tested less likley positive for opiates in urinalysis • No adverse events • No cardiological SAE were observed with LAAM

  36. Capsules with small pellets Tablets Duration of action: 24 hours onset of action: after 1,5 hours Peak: after 6 hours Registered medication in Austria since 1999 Oral-slow releasemorphine

  37. Oral slow-release Morphine Mitchell et al, DAD, 2003; ....... Oral slow-release for maintenance .... Fischer et al. Oral slow release morphine in pregnant opioid addicts; Addiction 1999; 94: 231-239 Kraigher et al; Slow release morphine for the treatment of opioid dependence; EAR 2005; 11:145-151 Eder et al. Double-blind, double-dummy comparison of slow-release morphine and methadone, Addiction 2005; 100:1101-1109 Is there a place ? ..... yes

  38. Heroin: yes or no? Rehm et al., The Lancet 2001: Feasibility, safety and efficacy of injectable heroin prescription for refratory opioid addicts: Van den Brink et al., BMJ 2003: Medical prescription of heroin to chronic, treatment resistent heroin dependent patients: two randomized trials. Yes, treatment shows safety & efficacy for a defined group of patients

  39. Clinical Expertise and Policy Context Patient Preference Research Evidence A model for evidence-based clinical decisions (from Haynes et al, 1996)

  40. ...and evidence-based medicine

  41. CONCLUSION • Individual needs in different countries: • legislation • education • financial support • Research-treatment • Ideal dosing • Comorbidity • Expand treatment • To establish a way between „laissez-faire“ and „overregulation“

  42. No, Doc - this time I don`t want to have a prescription, I want to talk !

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