Tiagabine for the Treatment of Cocaine Dependence – 1

Overview

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

Full Title of Study: “Tiagabine for the Treatment of Cocaine Dependence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

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.

Interventions

  • Drug: Tiagabine

Clinical Trial Outcome Measures

Primary Measures

  • Drug use
  • Cocaine use
  • Addiction severity
  • Clinical improvement

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Institute on Drug Abuse (NIDA)
  • Collaborator
    • University of Cincinnati
  • Provider of Information About this Clinical Study
    • Liza Gorgon / Clinical Trials Specialist, NIDA
  • Overall Official(s)
    • Eugene Somoza, M.D., Ph.D., Principal Investigator, Cincinnati VA Medical Center

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