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Tiagabine for the Treatment of Cocaine Dependence - 1

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tiagabine
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston University Medical Center
  • Cincinnati VA Medical Center
  • Dayton VA Medical Center
  • University of Texas Hlth Sci Ctr Houston

Outcomes

Primary Outcome Measures

Drug use
Cocaine use
Addiction severity
Clinical improvement

Secondary Outcome Measures

Full Information

First Posted
June 29, 2004
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT00086255
Brief Title
Tiagabine for the Treatment of Cocaine Dependence - 1
Official Title
Tiagabine for the Treatment of Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Cincinnati

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiagabine
Primary Outcome Measure Information:
Title
Drug use
Title
Cocaine use
Title
Addiction severity
Title
Clinical improvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Somoza, M.D., Ph.D.
Organizational Affiliation
Cincinnati VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Dayton VA Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
University of Texas Hlth Sci Ctr Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25938124
Citation
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.
Results Reference
derived

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Tiagabine for the Treatment of Cocaine Dependence - 1

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