NCT00086255

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2004

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2008

First QC Date

June 29, 2004

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (4)

  • Drug use

  • Cocaine use

  • Addiction severity

  • Clinical improvement

Interventions

TiagabineDRUG

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Please contact the participating site in your area for more information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Boston University Medical Center

Boston, Massachusetts, 02215, United States

Location

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220, United States

Location

Dayton VA Medical Center

Dayton, Ohio, 45428, United States

Location

University of Texas Hlth Sci Ctr Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 25938124DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Tiagabine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Eugene Somoza, M.D., Ph.D.

    Cincinnati VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 29, 2004

First Posted

June 30, 2004

Study Start

October 1, 2002

Study Completion

June 1, 2004

Last Updated

January 12, 2017

Record last verified: 2008-08

Locations

US(4)