BUPRENORPHINE TREATMENT OF OPIOID DEPENDENCE - CLINICAL-TRIAL OF DAILY VERSUS ALTERNATE-DAY DOSING

Buprenorphine, a mu-opioid partial agonist, has demonstrated efficacy for the treatment of opioid dependence comparable to that of methadone . The clinical utility of buprenorphine would be enhanced if it could be dosed on a less than daily basis. The current study is a parallel-g roup outpatient clinical trial of daily versus alternate-dal dosing wi th 8 mg sublingual (s.l.) buprenorphine. Participants were randomly as signed to daily (n = 51) or alternate-day (n = 48) schedules of active medication administration for an 11-week double-blind trial. Patients assigned to alternate-day buprenorphine received placebo every other day. Primary outcome measures were retention in treatment and urine sp ecimens positive for opiates. Clinic attendance, dose adequacy ratings , withdrawal symptomatology, and urine specimens positive for cocaine were secondary outcome measures. Neither endpoint analysis with the in tent-to-treat sample nor time course analysis with treatment completer s revealed any statistically significant differences between the dosin g schedules on any outcome measure. Examination of 95% confidence inte rvals suggested a non-significant trend for the daily dosing schedule to have superior clinical efficacy at the dose tested. Nevertheless, t hese results are generally consistent with previous studies of less th an daily dosing with buprenorphine and support the conclusion that an alternate-day dosing schedule can be effective in and acceptable to a substantial portion of patients.