Back to resultsTrial of Buprenorphine/Naloxone for Opiate Dependence - 2
Primary Purpose
Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opiate dependence
Eligibility Criteria
Please contact site for information.
Sites / Locations
- University of Pennsylvania
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000353
First Posted
September 20, 1999
Last Updated
January 17, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00000353
Brief Title
Trial of Buprenorphine/Naloxone for Opiate Dependence - 2
Official Title
Efficacy/Safety Trial of Buprenorphine/Nx for Opiate Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
October 1996 (undefined)
Primary Completion Date
September 1997 (Actual)
Study Completion Date
October 1997 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Pennsylvania
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Substance-Related Disorders
Keywords
opiate dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles O'Brien, M.D., Ph.D.
Organizational Affiliation
PDVAMC Treatment Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 6178
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Buprenorphine/Naloxone for Opiate Dependence - 2
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