Conditions: Opiate Dependence Drug Dependence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 241
Healthy volunteers: no

Brief summary:
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.

Detailed description:

Arms:
arm 1: Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2. arm 2: Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2.

Interventions: intervention 1: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 intervention 2: Subutex, Buprenorphine Hydrochloride, SCH 28444
Intervention descriptions: intervention 1: Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days intervention 2: Subutex sublingual tablet 4-24 mg, daily for 28 days

Protocol document: