NCT00015028

Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 23 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Opioid-Related Disorders
• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	Buprenorphine/naloxone

Timeline

• Start date: 1996-11-01
• Primary completion: 1996-12-01
• Completion: 1997-01-01
• First posted: 2001-04-18
• Last updated: 2017-01-16

Locations

1 site across 1 country: United States