NCT00000302CompletedPhase 3
Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Locations
- 2
- Primary Endpoint
- Drug craving
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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-
- •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.
Outcomes
Primary Outcomes
Drug craving
Drug use
Retention
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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