Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

Phase 3

Completed

• Conditions: Heroin Dependence; Substance-Related Disorders

• Registration Number: NCT00015171
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

Detailed Description

The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Study Timeline

• Study Start: 1996-04
• Primary Completion: 1997-05
• Study Completion: 1997-06
• Status Verified: 1999-01
• Study First Submitted QC: 2001-04-17
• Study First Submitted: 2001-04-18
• Study First Posted: 2001-04-18
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age

Exclusion Criteria

Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective rating
Craving
Drug use
Retention
Opioid withdrawal

Trial Locations

Locations (1)

New York MDRU; 🇺🇸 New York, New York, United States