Serotonin, Impulsivity, and Cocaine Dependence Treatment

Cocaine Dependence Clinical Trial

Official title:

Serotonin, Impulsivity, and Cocaine Dependence Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297505
• Other study ID #: R01DA008425
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2006
• Last updated: January 11, 2017
• Start date: April 2001
• Est. completion date: November 2004

Study information

• Verified date: February 2006
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Impulsive Behavior

Intervention

Drug:
• citalopram

Locations

Country	Name	City	State
United States	University of Texas - Houston Health Science Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of cocaine metabolites in urine weekly.
Secondary	Retention rate and cocaine cravings weekly.