Back to resultsBuprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
Primary Purpose
Opioid-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine formulation: liquid vs. tablet
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opioid dependence
Eligibility Criteria
Inclusion Criteria: M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.
Sites / Locations
- Friends Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1; liquid formulation
2; tablet formulation
Arm Description
liquid formulation
tablet formulation
Outcomes
Primary Outcome Measures
blood level
Secondary Outcome Measures
drug use
craving
withdrawal symptoms
Full Information
NCT ID
NCT00000320
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000320
Brief Title
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
Official Title
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
August 1999 (Actual)
Study Completion Date
August 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."
Detailed Description
1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
opioid dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1; liquid formulation
Arm Type
Active Comparator
Arm Description
liquid formulation
Arm Title
2; tablet formulation
Arm Type
Active Comparator
Arm Description
tablet formulation
Intervention Type
Drug
Intervention Name(s)
Buprenorphine formulation: liquid vs. tablet
Other Intervention Name(s)
Subutex, Suboxone
Intervention Description
random assignment to liquid buprenorphine or tablet buprenorphine
Primary Outcome Measure Information:
Title
blood level
Time Frame
across study duration
Secondary Outcome Measure Information:
Title
drug use
Time Frame
across study duration
Title
craving
Time Frame
across study duration
Title
withdrawal symptoms
Time Frame
across study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.
Exclusion Criteria:
Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.
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
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
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