Tiagabine for the Treatment of Cocaine Dependence - 1

NCT ID: NCT00086255

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cocaine-Related Disorders

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tiagabine

Intervention Type DRUG

Eligibility Criteria

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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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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NIDA

Principal Investigators

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Eugene Somoza, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Cincinnati VA Medical Center

Locations

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Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Site Status

Dayton VA Medical Center

Dayton, Ohio, United States

Site Status

University of Texas Hlth Sci Ctr Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.

Reference Type DERIVED
PMID: 25938124 (View on PubMed)

Other Identifiers

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NIDA-CTO-0012-1

Identifier Type: -

Identifier Source: org_study_id

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