Back to resultsBuprenorphine Combination Tablet Feasibility - 1
Primary Purpose
Opioid-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
Eligibility Criteria
Inclusion Criteria: Males/Females ages 21-50, opiate dependence according to DSM-IV criteria, self-reported use within the last 30 days, agreeable to conditions of study and signed informed consent Exclusion Criteria: Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on etoh or benzodiazepines or other sedative-hypnotics, acute hepatitis, other medical conditions that deem participation to be unsafe.
Sites / Locations
- Friends Research Institute
Outcomes
Primary Outcome Measures
Withdrawal symptoms
Opiate use
Opiate craving
Secondary Outcome Measures
Full Information
NCT ID
NCT00000298
First Posted
September 20, 1999
Last Updated
August 16, 2005
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000298
Brief Title
Buprenorphine Combination Tablet Feasibility - 1
Official Title
Buprenorphine Combination Tablet Feasibility
Study Type
Interventional
2. Study Status
Record Verification Date
January 1996
Overall Recruitment Status
Completed
Study Start Date
August 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine target dose range of buprenorphine/naloxone combination tablet that provides therapeutic response in opiate addicts with low to moderate dependence, and to identify appropriate initial induction dose in opiate addicts with low to moderate dependence."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Primary Outcome Measure Information:
Title
Withdrawal symptoms
Title
Opiate use
Title
Opiate craving
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males/Females ages 21-50, opiate dependence according to DSM-IV criteria, self-reported use within the last 30 days, agreeable to conditions of study and signed informed consent
Exclusion Criteria:
Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on etoh or benzodiazepines or other sedative-hypnotics, acute hepatitis, other medical conditions that deem participation to be unsafe.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Buprenorphine/nalaxone cmbination tablet: First clinical experience (j. Add Dis 1997, in press). Buprenorphine/naloxone combination tablet: First clincial experience (J Add Dis 1997, in press).
Results Reference
background
Learn more about this trial
Buprenorphine Combination Tablet Feasibility - 1
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