NCT00082485CompletedPhase 2
Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence
National Institute on Drug Abuse (NIDA)8 sites in 1 country160 target enrollmentStarted: June 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 160
- Locations
- 8
- Primary Endpoint
- Effects of medication on cocaine craving
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.
Detailed Description
Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence
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
- •Subject must have DSM-IV diagnosis of cocaine dependence.
- •Subject must be seeking treatment for cocaine dependence.
- •Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures.
Exclusion Criteria
- •Please contact site for more information.
Arms & Interventions
2
Placebo Comparator
Intervention: Placebo (Other)
1
Active Comparator
Intervention: Baclofen (Drug)
Outcomes
Primary Outcomes
Effects of medication on cocaine craving
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (8)
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