Back to resultsStudy Comparing Liquid and Tablet Buprenorphine Formulations - 5
Primary Purpose
Heroin Dependence
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence
Eligibility Criteria
Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. 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
Drug use
Retention
Drug craving
Secondary Outcome Measures
Full Information
NCT ID
NCT00000302
First Posted
September 20, 1999
Last Updated
November 3, 2005
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000302
Brief Title
Study Comparing Liquid and Tablet Buprenorphine Formulations - 5
Official Title
Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations
Study Type
Interventional
2. Study Status
Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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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 compare liquid and tablet buprenorphine formulations.
Detailed Description
Participants were inducted on either liquid or tablet buprenorphine, in a double-blind, double-dummy manner. They each reached a steady state by the second week, and were scheduled to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Primary Outcome Measure Information:
Title
Drug use
Title
Retention
Title
Drug 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:
M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. 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
Learn more about this trial
Study Comparing Liquid and Tablet Buprenorphine Formulations - 5
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