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


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


METHODS
Three methadone clinics in Australia.


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


METHODS
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.


METHODS
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.


RESULTS
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 chi 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.
Mattick
Richard P
RP
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia. r.mattick@unsw.edu.au
Ali
Robert
R
White
Jason M
JM
O'Brien
Susannah
S
Wolk
Seija
S
Danz
Cath
C
D000328:Adult; D002047:Buprenorphine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008691:Methadone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D016896:Treatment Outcome
D009292:Narcotic Antagonists; D002047:Buprenorphine; D008691:Methadone