Back to resultsBuprenorphine/Naloxone in the Treatment of Heroin Dependence - 14
Primary Purpose
Opioid Dependence, Substance-Related Disorders
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring Opioid Dependence
Eligibility Criteria
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
Sites / Locations
- University of California
- VA Medical Center
- VA Medical Center
- New York VAMC
- VA PUget Sound Helath Care System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Buprenorphine/Naloxone
Arm Description
Outcomes
Primary Outcome Measures
Craving
Retention
Opioid withdrawal
Subjective rating
Secondary Outcome Measures
Full Information
NCT ID
NCT00015340
First Posted
April 18, 2001
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
New York MDRU
1. Study Identification
Unique Protocol Identification Number
NCT00015340
Brief Title
Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14
Official Title
Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
September 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
New York MDRU
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Substance-Related Disorders
Keywords
Opioid Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
582 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buprenorphine/Naloxone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Primary Outcome Measure Information:
Title
Craving
Title
Retention
Title
Opioid withdrawal
Title
Subjective rating
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Casadonte, M.D.
Organizational Affiliation
New York VAMC
Official's Role
Study Chair
Facility Information:
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
VA Medical Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
VA Medical Center
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
New York VAMC
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
VA PUget Sound Helath Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14
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