Completed

Tiagabine for the Treatment of Cocaine Dependence

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What is being tested

Data Collection

Who is being recruted

Mental Disorders+1

+ Substance-Related Disorders

+ Cocaine-Related Disorders

From 18 to 99 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2002
See protocol details

Summary

Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2002

Actual date on which the first participant was enrolled.

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.

Official TitleTiagabine for the Treatment of Cocaine Dependence 
NCT00086255
Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersCocaine-Related DisordersChemically-Induced Disorders

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Boston University Medical Center

Boston, United StatesSee the location
Suspended

Cincinnati VA Medical Center

Cincinnati, United States
Suspended

Dayton VA Medical Center

Dayton, United States
Suspended

University of Texas Hlth Sci Ctr Houston

Houston, United States
Completed4 Study Centers