A pilot study for a randomized controlled and patient preference trial of buprenorphine versus methadone maintenance treatment in the management of opiate dependent patients

Aims: To assess the feasibility of conducting an RCT comparing buprenorphine and methadone maintenance therapy in Norfolk. Design: Forty-two opiate dependent patients were given the option of being randomized or choosing between open label buprenorphine or methadone maintenance treatment for 6 months. Dosage was assessed individually using a flexible regime. Findings: No subjects agreed to randomization. At 6 months more methadone patients were retained (68 vs. 55% for buprenorphine), however, after adjustment for baseline differences between the groups results favoured buprenorphine, but were not statistically significant (odds ratio for retention BMT vs. MMT=1.57, 95% CI, 0.30-8.29, p=0.60). The buprenorphine group showed a nonsignificant advantage in illicit opiate use (45 vs. 66% p=0.43) and CHRISTO scores at 6 months (-0.85 units lower score, 95% CI, -4.93 to +3.23, p=0.67). In this study, predictors of retention in treatment at six months were lower (better) CHRISTO score (p=0.01), age below 29.5 years (p=0.02) and of borderline statistical significance was being married or cohabiting (p=0.06). Conclusions: A local RCT is not feasible. As a pilot this study lacked power but the results suggest that, in practice, in the UK, buprenorphine may be more able to retain patients in treatment, suppress illicit opiate use and improve functioning. Given the significantly higher cost of buprenorphine a larger study is needed to answer these questions.