Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

Phase 4

Completed

• Conditions: Opioid Dependence; Substance-Related Disorders
• Interventions: Drug: Buprenorphine/naloxone

• Registration Number: NCT00015340
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Detailed Description

The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.

Study Timeline

• Study Start: 1999-08
• Study First Submitted QC: 2001-04-17
• Study First Submitted: 2001-04-18
• Study First Posted: 2001-04-18
• Primary Completion: 2001-08
• Study Completion: 2001-09
• Status Verified: 2016-08
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

Inclusion Criteria

• Completion of Cooperative Study 1008 A/B

Exclusion Criteria

• Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Buprenorphine/Naloxone	Buprenorphine/naloxone	-

Primary Outcome Measures

Name	Time	Method
Craving
Retention
Opioid withdrawal
Subjective rating

Trial Locations

Locations (4)

VA PUget Sound Helath Care System; 🇺🇸 Seattle, Washington, United States

VA Medical Center; 🇺🇸 Hines, Illinois, United States

University of California; 🇺🇸 Los Angeles, California, United States

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