A CONTROLLED TRIAL COMPARING BUPRENORPHINE AND METHADONE-MAINTENANCE IN OPIOID DEPENDENCE

Background: Buprenorphine is a partial agonist at the mu-opioid recept or that has been proposed as an alternative to traditional full agonis t maintenance therapy for the treatment of opioid addiction. We report on a clinical trial in which the relative safety and efficacy of long -term fixed-dose buprenorphine maintenance was examined in comparison to low- and high-dose methadone maintenance. Methods: Two hundred twen ty-five treatment-seeking opioid addicts (46 women, 179 men) were rand omly assigned to receive, in a double-blind manner, either 8 mg/d of b uprenorphine, 30 mg/d of methadone, or 80 mg/d of methadone maintenanc e over a 1-year period. Objective and subjective measures of efficacy (urine toxicology, retention, craving, and withdrawal symptoms) were e xamined at the study midpoint and at termination, and safety data were tabulated over the entire 52-week study period. Results: Patients ass igned to high-dose methadone maintenance performed significantly bette r on measures of retention, opioid use, and opioid craving than either the low-dose methadone or the buprenorphine group at both 26-week and 52-week time points. Performance on these measures was virtually iden tical between the latter two groups. No serious adverse health effects attributable to buprenorphine were noted. Conclusions: Buprenorphine maintenance at 8 mg/d appears to be less than optimally efficacious un der the conditions of the present study. Continued research is needed to reconcile these findings with the more positive results reported by other investigative groups. There are no apparent health risks associ ated with long-term buprenorphine maintenance at this dosage.