Maintenance treatment for opioid dependence with slow-release oral morphine: A randomized cross-over, non-inferiority study versus methadone

Addiction

Volumn 109, Issue 4, 2014, Pages 617-626

  Beck, Thilo ^a   Haasen, Christian ^b   Verthein, Uwe ^b   Walcher, Stephan ^c   Schuler, Christoph ^d   Backmund, Markus ^e,f   Ruckes, Christian ^g   Reimer, Jens ^b  

^a Arud Centres for Addiction Medicine   (Switzerland)

^b UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^c Concept Schwerpunktpraxis Sucht ^*  (Germany)

^d Praxis Turmstrasse   (Germany)

^e Praxiszentrum im Tal   (Germany)

^f UNIVERSITY OF MUNICH   (Germany)

^g UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

Author keywords

Dose response; Maintenance treatment; Methadone; Opioid addiction; Retention rate; Slow release oral morphine

Indexed keywords

6-O-MONOACETYLMORPHINE; ACETYLCODEINE; CODEINE; DELAYED RELEASE FORMULATION; METHADONE; MORPHINE; MORPHINE DERIVATIVE; NARCOTIC AGENT;

ADULT; ANALOGS AND DERIVATIVES; CONTROLLED STUDY; CROSSOVER PROCEDURE; DELAYED RELEASE FORMULATION; FEMALE; HUMAN; MAINTENANCE CHEMOTHERAPY; MALE; MEDICATION COMPLIANCE; MIDDLE AGED; OPIATE SUBSTITUTION TREATMENT; OPIOID-RELATED DISORDERS; ORAL DRUG ADMINISTRATION; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; URINE;

ADMINISTRATION, ORAL; ADULT; CODEINE; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; FEMALE; HUMANS; MAINTENANCE CHEMOTHERAPY; MALE; MEDICATION ADHERENCE; METHADONE; MIDDLE AGED; MORPHINE; MORPHINE DERIVATIVES; NARCOTICS; OPIATE SUBSTITUTION TREATMENT; OPIOID-RELATED DISORDERS; TREATMENT OUTCOME;

EID: 84896695750     PISSN: 09652140     EISSN: 13600443     Source Type: Journal    
DOI: 10.1111/add.12440     Document Type: Article

References (47)

1. World Health Organization/United Nations Office on Drugs and Crime/Joint United Nations Programme on HIV/AIDS (WHO/UNDOC/UNAIDS). WHO/UNDOC/UNAIDS position paper. 2004. Available at: http://www.who.int/substance_abuse/publications/en/PositionPaper_flyer_English.pdf (accessed 7 February 2012) (archived at http://www.webcitation.org/6M6jvn6pt on 24 December 2013).
2. Amato L., Minozzi S., Davoli M., Vecchi S. Psychosocial combined with agonist maintenance treatments versus agonist maintenance treatments alone for treatment of opioid dependence. Cochrane Database Syst Rev 2011; 10: CD004147.
3. Kreek M. J. Neurobiological basis for use of opioid agonist maintenance in the treatment of heroin addiction. In: Waal H., Haga E., editors. Maintenance Treatment of Heroin Addiction. Oslo: Cappelen Akademisk Forlag; 2003, pp. 10-39.
4. Amato L., Davoli M., Perucci C. A., Ferri M., Faggiano F., Mattick R. P. An overview of systematic reviews of the effectiveness of opiate maintenance therapies: available evidence to inform clinical practice and research. J Subst Abuse Treat 2005; 28: 321-329.
5. Dyer K. R., White J. M. Patterns of symptom complaints in methadone maintenance patients. Addiction 1997; 92: 1445-1455.
6. Brown R., Kraus C., Flemming M., Reddy S. Methadone: applied pharmacology and use as adjunctive treatment in chronic pain. Postgrad Med J 2004; 80: 654-659.
7. Woody G. E. New horizons: sustained release morphine as agonist treatment. Addiction 2005; 100: 1758-1759.
8. Haasen C., van den Brink W. Innovations in agonist maintenance treatment of opioid-dependent patients. Curr Opin Psychiatry 2006; 19: 631-636.
9. White J. M., Lopatko O. V. Opioid maintenance: a comparative review of pharmacological strategies. Expert Opin Pharmacother 2007; 8: 1-11.
10. Trescot A. M., Datta S., Lee M., Hansen H. Opioid pharmacology. Pain Physician 2008; 11: 133-153.
11. Borg L., Kravets I., Kreek M. J. The pharmacology of long-acting as contrasted with short-acting opioids. In: Ries R. K., Fiellin D. A., Miller S. C., Saitz R., editors. Principles of Addiction Medicine, 4th edn. Philadelphia: Lipincott Williams & Wilkins; 2009, pp. 117-131.
12. Dole V. P., Nyswander M. A medical treatment for diacetylmorphine (heroin) addiction. A clinical trial with methadone hydrochloride. JAMA 1965; 193: 646-650.
13. Broomhead A., West R., Eglinton L., Jones M., Bubner R., Sienko D. etal. Comparative single-dose pharmacokinetics of sustained-release and modified-release morphine sulfate capsules under fed and fasting conditions. Clin Drug Invest 1997; 13: 162-170.
14. Hagen N. A., Thirlwell M., Eisenhoffer J., Quigley P., Harsanyi Z., Darke A. Efficacy, safety, and steady-state pharmacokinetics of once-a-day controlled-release morphine (MS Contin XL) in cancer pain. J Pain Symptom Manage 2005; 29: 80-90.
15. Fischer G., Presslich O., Diamant K., Schneider C., Pezawas L., Kasper S. Oral morphine-sulphate in the treatment of opiate dependent patients. Alcoholism 1996; 32: 35-43.
16. Mitchell T. B., White J. M., Somogyi A. A., Bochner F. Slow-release morphine versus methadone: a crossover comparison of patient outcomes and acceptability as maintenance pharmacotherapies for opioid dependence. Addiction 2004; 99: 940-945.
17. Kraigher D., Jagsch R., Gombas W., Ortner R., Eder H., Primorac A. etal. Use of slow-release oral morphine for the treatment of opioid dependence. Eur Addict Res 2005; 11: 145-151.
18. Eder H., Jagsch R., Kraigher D., Primorac A., Ebner N., Fischer G. Comparative study of the effectiveness of slow-release morphine and methadone for opioid maintenance therapy. Addiction 2005; 100: 1101-1109.
19. Hermann P., Wagner W., Lindenbauer B. Safety and efficacy of oral prolonged release morphine for the maintenance therapy for opioid dependence-results of a pilot study in outpatients. Suchtmed Forsch Praxis 2005; 7: 215-220.
20. Vasilev G. N., Alexieva D. Z., Pavlova R. Z. Safety and efficacy of oral slow release morphine for maintenance treatment in heroin addicts: a 6-month open non comparative study. Eur Addict Res 2006; 12: 53-60.
21. Kastelic A., Dubajic G., Strbad E. Slow-release oral morphine for maintenance treatment of opioid addicts intolerant to methadone or with inadequate withdrawal suppression. Addiction 2008; 103: 1837-1846.
22. Bond A. J., Reed K. D., Beavan P., Strang J. After the randomized injectable opiate treatment trial: post-trial investigation of slow-release oral morphine as an alternative opiate maintenance medication. Drug Alcohol Rev 2012; 31: 492-498.
23. Giacomuzzi S., Kemmler G., Ertl M., Riemer Y. Opioid addicts at admission vs. slow-release oral morphine, methadone, and sublingual buprenorphine maintenance treatment participants. Subst Use Misuse 2006; 41: 223-244.
24. Jegu J., Gallini A., Soler P. Slow-release oral morphine for opioid maintenance treatment: a systematic review. Br J Clin Pharmacol 2011; 71: 832-843.
25. Mattick R. P., Kimber J., Breen C., Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev 2008; (2): CD002207. doi: 10.1002/14651858.CD002207.pub3
26. Senn S. Cross-over trial in drug development: theory and practice. J Stat Plan Inference 2001; 96: 29-40.
27. D'Agostino R. B. Sr, Massaro J. M., Sullivan L. M. Non-inferiority trials: design concepts and issues-the encounters of academic consultants in statistics. Stat Med 2003; 22: 169-186.
28. Matsumoto M., Nishimura T. Mersenne twister: a 623-dimensionally equidistributed uniform pseudo-random number generator. ACM Trans Model Comput Simul 1998; 8: 3-30.
29. Sturm S., Hammann F., Drew J., Maurer H. H., Scholer A. An automated screening method for drugs and toxic compounds in human serum and urine using liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2010; 878: 2726-2732.
30. Scott I. A. Non-inferiority trials: determining whether alternative treatments are good enough. Med J Aust 2009; 190: 326-330.
31. Donovan D. M., Bigelow G. E., Brigham G. S., Carroll K. M., Cohen A. J., Gardin J. G. etal. Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials. Addiction 2012; 107: 694-708.
32. Reisfield G. M., Goldberger B. A., Bertholf R. L. 'False-positive' and 'false-negative' test results in clinical urine drug testing. Bioanalysis 2009; 1: 937-952.
33. Stefanidou M., Athanaselis S., Spiliopoulou C., Dona A., Maravelias C. Biomarkers of opiate use. Int J Clin Pract 2010; 64: 1712-1718.
34. Jones B., Jarvis P., Lewis J. A., Ebbutt A. F. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996; 313: 36-39.
35. Lange S., Freitag G. Choice of delta: requirements and reality-results of a systematic review. Biomed J 2005; 47: 12-27.
36. European Medicines Agency (EMEA). Guideline on the choice of the non-inferiority margin. Doc.Ref.: EMEA/CPMP/EWP/2158/99, 27 July 2005, pp. 1-11. (Accessed 14 February 2012) (archived at http://www.webcitation.org/6M6j4VSRJ on 24 December 2013).
37. Hung H. M., Wang S. J., O'Neill R. A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials. Biomed J 2005; 47: 28-36.
38. Food and Drug Administration (FDA). Guidance for industry non-inferiority clinical trials. March 2010. Washington, DC: US Department of Health and Human Services.
39. Strain E. C., Stitzer M. L., Liebson I., Bigelow G. E. Dose-response effects of methadone in the treatment of opioid dependence. Ann Intern Med 1993; 119: 23-27.
40. Bammer G., Dobler-Mikola A., Fleming P. M., Strang J., Uchtenhagen A. The heroin prescribing debate: integrating science and politics. Science 1999; 284: 1277-1278.
41. Gossop M. Randomised and controlled, but irrelevant? In: Waal H., Haga E., editors. Maintenance Treatment of Heroin Addiction-Evidence at the Crossroads. Oslo: Cappelen Akademisk Forlag; 2003, pp. 91-105.
42. Freemantle N., Blonde L., Bolinder B., Gerber R. A., Hobbs F. D., Martinez L. etal. Real-world trials to answer real-world questions. Pharmacoeconomics 2005; 23: 747-754.
43. Kane J. M. Issues in clinical trial designs. In: Davis K. L., Charney D., Coyle J. T., Nemeroff C. H., editors. Neuropharmacology: The Fifth Generation of Progress. Brentwood, TN: American College of Neuropsychopharmacology; 2002, pp. 537-546.
44. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Reviewing current practice in drug-substitution treatment in the European Union. Insights Series, number 3. Lisbon: EMCDDA; 2000.
45. Casati A., Sedefov R., Pfeiffer-Gerchel T. Misuse of medicines in the European Union: a systematic review of the literature. Eur Addict Res 2012; 18: 228-245.
46. Dale-Perera A., Goulão J., Stöver H. Quality of care provided to patients receiving opioid maintenance treatment in Europe: results from the EQUATOR analysis. Heroin Addict Relat Clin Probl 2012; 14: 23-38.
47. Beer B., Rabl W., Libiseller K., Giacomuzzi S., Riemer Y., Pavlic M. Impact of slow-release oral morphine on drug abusing habits in Austria. Neuropsychiatr 2010; 24: 108-117.