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Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients

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Abstract Aims 

To assess the efficacy of buprenorphine compared with methadone maintenance therapy for opioid dependence in a large sample using a flexible dosing regime and the marketed buprenorphine tablet. Design 

Patients were randomized to receive buprenorphine or methadone over a 13-week treatment period in a double-blind, double-dummy trial. Setting 

Three methadone clinics in Australia. Participants 

Four hundred and five opioid-dependent patients seeking treatment. Intervention 

Patients received buprenorphine or methadone as indicated clinically using a flexible dosage regime. During weeks 1–6, patients were dosed daily. From weeks 7–13, buprenorphine patients received double their week 6 dose on alternate days. Measurements 

Retention in treatment, and illicit opioid use as determined by urinalysis. Self-reported drug use, psychological functioning, HIV-risk behaviour, general health and subjective ratings were secondary outcomes. Findings 

Intention-to-treat analyses revealed no significant difference in completion rates at 13 weeks. Methadone was superior to buprenorphine in time to termination over the 13-week period (Wald 2 = 4.371, df = 1, P = 0.037), but not separately for the single-day or alternate-day dosing phases. There were no significant between-group differences in morphine-positive urines, or in self-reported heroin or other illicit drug use. The majority (85%) of the buprenorphine patients transferred to alternate-day dosing were maintained in alternate-day dosing. Conclusions 

Buprenorphine did not differ from methadone in its ability to suppress heroin use, but retained approximately 10% fewer patients. This poorer retention was due possibly to too-slow induction onto buprenorphine. For the majority of patients, buprenorphine can be administered on alternate days.

Keywords: Buprenorphine; methadone; opioid dependence; randomized trial; treatment outcome

Document Type: Research Article


Affiliations: 1: Drug and Alcohol Services Council of South Australia, Adelaide 2: National Drug and Alcohol Research Centre (NDARC), University of New South Wales, Sydney, 3: and Department of Clinical and Experimental Pharmacology, Adelaide University, Adelaide, Australia

Publication date: April 1, 2003


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