Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone|
- Drug use
- HIV risk behaviors
- Adverse events
- Medical evaluation
|Study Start Date:||November 1996|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015028
|United States, Ohio|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Eugene Somoza, M.D., Ph.D.||Cincinnati MDRU|