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NCT00015340 Clinical Trial

Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

Substance-Related Disorders Clinical Trial

Official title:
Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00015340
Other study ID # NIDA-5-0013-14
Secondary ID Y01-5-0013-14
Status Completed
Phase Phase 4
First received April 18, 2001
Last updated January 11, 2017
Start date August 1999
Est. completion date September 2001

Study information
Verified date August 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 582
Est. completion date September 2001
Est. primary completion date August 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 59 Years
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine/naloxone

Locations
Country Name City State
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 VA PUget Sound Helath Care System Seattle Washington
United States VA Medical Center Tampa Florida

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) New York MDRU

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Craving
Primary Retention
Primary Opioid withdrawal
Primary Subjective rating
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