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

ABSTRACT:

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).

Finding

SUBMITTER: Rosenthal RN 

PROVIDER: S-EPMC4669043 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature