Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone

Aims To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open‐label sublingual buprenorphine/naloxone tablets (BNX). Design Randomized, double‐blind, placebo‐controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open‐label BNX (12–16 mg/day) (n = 119). Setting Twenty addiction treatment centers. Participants Adult out‐patients (ages 18–65) with DSM‐IV‐TR opioid dependence. Measurements The primary efficacy end‐point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF). Findings The BI CDF was significantly different from placebo (P