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Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

Substance-Related Disorders Clinical Trial

Official title:
CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.

Clinical Trial Description

This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00015028
Study type Interventional
Source National Institute on Drug Abuse (NIDA)
Contact
Status Completed
Phase Phase 2
Start date November 1996
Completion date January 1997
View Details
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