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Tiagabine for the Treatment of Cocaine Dependence - 1

This study has been completed.
Sponsor:
Collaborator:
University of Cincinnati
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00086255
First received: June 29, 2004
Last updated: August 15, 2008
Last verified: August 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Cocaine-Related Disorders
 Drug: Tiagabine
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Tiagabine for the Treatment of Cocaine Dependence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Drug use
  • Cocaine use
  • Addiction severity
  • Clinical improvement

Estimated Enrollment: 140
Study Start Date: October 2002
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086255

Locations
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
Investigators
Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati VA Medical Center
  More Information

No publications provided

Responsible Party: Liza Gorgon / Clinical Trials Specialist, NIDA
ClinicalTrials.gov Identifier: NCT00086255     History of Changes
Other Study ID Numbers: NIDA-CTO-0012-1
Study First Received: June 29, 2004
Last Updated: August 15, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Tiagabine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
GABA Agonists
GABA Agents

ClinicalTrials.gov processed this record on May 16, 2013