drugset / Trial / NCT00637000

Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

NCT00637000

Phase 2 Completed 38 enrolled Indivior Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

Timeline

Start
2008-03
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 24 mg Subcutaneous
Subject Buprenorphine/naloxone Unknown 24 mg Subcutaneous

Indications