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Tiagabine for the Treatment of Cocaine Dependence - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00086255
Recruitment Status : Completed
First Posted : June 30, 2004
Last Update Posted : January 12, 2017
University of Cincinnati
Information provided by:
National Institute on Drug Abuse (NIDA)

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

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Tiagabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Tiagabine for the Treatment of Cocaine Dependence
Study Start Date : October 2002
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Drug use
  2. Cocaine use
  3. Addiction severity
  4. Clinical improvement

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00086255

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United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02215
United States, Ohio
Cincinnati VA Medical Center
Cincinnati, Ohio, United States, 45220
Dayton VA Medical Center
Dayton, Ohio, United States, 45428
United States, Texas
University of Texas Hlth Sci Ctr Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Cincinnati
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Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati VA Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Liza Gorgon / Clinical Trials Specialist, NIDA Identifier: NCT00086255    
Other Study ID Numbers: NIDA-CTO-0012-1
First Posted: June 30, 2004    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2008
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
GABA Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs