NCT00033033CompletedPhase 2
Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence
National Institute on Drug Abuse (NIDA)6 sites in 1 country140 target enrollmentStarted: July 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 140
- Locations
- 6
- Primary Endpoint
- Cocaine use
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.
Detailed Description
To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.
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 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method
Exclusion Criteria
- •Additional criteria available during screening at the site.
Outcomes
Primary Outcomes
Cocaine use
Addiction severity
Cocaine withdrawal
Adverse events
Clinical improvement
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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