Serotonin, Impulsivity, and Cocaine Dependence Treatment

Phase 2

Completed

• Conditions: Cocaine Dependence

• Registration Number: NCT00297505
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.

Detailed Description

Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.

Study Timeline

• Study Start: 2001-04
• Study Completion: 2004-11
• Status Verified: 2006-02
• Study First Submitted: 2006-02-27
• Study First Submitted QC: 2006-02-27
• Study First Posted: 2006-02-28
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.
• female subjects: a negative pregnancy test

Exclusion Criteria

• current or past DSM-IV Axis I disorder other than substance abuse/dependence
• any serious non-psychiatric medical illness requiring ongoing medical treatment
• substance dependence other than cocaine within the last 3 months
• negative urine drug screen for cocaine at time of testing
• for female subjects: a positive pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The presence of cocaine metabolites in urine weekly.

Secondary Outcome Measures

Name	Time	Method
Retention rate and cocaine cravings weekly.

Trial Locations

Locations (1)

University of Texas - Houston Health Science Center; 🇺🇸 Houston, Texas, United States