NCT00000341CompletedPhase 2
Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine
National Institute on Drug Abuse (NIDA)1 site in 1 country1 target enrollmentStarted: August 1, 1996Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Subjective and observer rater physiological effects of bup
Study Overview
Brief Summary
The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •M/F ages 21-
- •Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent.
Exclusion Criteria
- •Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Outcomes
Primary Outcomes
Subjective and observer rater physiological effects of bup
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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