Tiagabine for the Treatment of Cocaine Dependence - 1

Cocaine-Related Disorders Clinical Trial

Official title:

Tiagabine for the Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086255
• Other study ID #: NIDA-CTO-0012-1
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2004
• Last updated: January 11, 2017
• Start date: October 2002
• Est. completion date: June 2004

Study information

• Verified date: August 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Tiagabine

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	Dayton VA Medical Center	Dayton	Ohio
United States	University of Texas Hlth Sci Ctr Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug use
Primary	Cocaine use
Primary	Addiction severity
Primary	Clinical improvement