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Tiagabine for the Treatment of Cocaine Dependence - 1

Phase 2
Completed
Conditions
Cocaine-Related Disorders
Registration Number
NCT00086255
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Brief Summary

The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.

Detailed Description

To assess the efficacy and safety of tiagabine in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that tiagabine treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE). This is a double-blind, placebo-controlled, parallel-group design study, in which, after screening and a 2-week baseline assessment period, subjects will be equally randomly assigned to 1 of 2 treatment groups, tiagabine or matched placebo.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
140
Inclusion Criteria

Must be at least 18 years of age and be seeking treatment for cocaine dependence. Have the ability to understand, and having understood, provide written informed consent. If female, agree to use a method of birth control as indicated by the clinician. Please contact the participating site in your area for more information.

Exclusion Criteria

Please contact the participating site in your area for more information.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Drug use
Cocaine use
Addiction severity
Clinical improvement
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Cincinnati VA Medical Center

🇺🇸

Cincinnati, Ohio, United States

Boston University Medical Center

🇺🇸

Boston, Massachusetts, United States

University of Texas Hlth Sci Ctr Houston

🇺🇸

Houston, Texas, United States

Dayton VA Medical Center

🇺🇸

Dayton, Ohio, United States

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