NCT00000320CompletedPhase 1
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution
National Institute on Drug Abuse (NIDA)1 site in 1 country120 target enrollmentStarted: October 1, 1997Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- blood level
Study Overview
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
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •M/F ages 18-
- •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.
Arms & Interventions
2; tablet formulation
Active Comparator
tablet formulation
Intervention: Buprenorphine formulation: liquid vs. tablet (Drug)
1; liquid formulation
Active Comparator
liquid formulation
Intervention: Buprenorphine formulation: liquid vs. tablet (Drug)
Outcomes
Primary Outcomes
blood level
Time Frame: across study duration
Secondary Outcomes
- craving(across study duration)
- withdrawal symptoms(across study duration)
- drug use(across study duration)
Investigators
Study Sites (1)
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