Serotonin, Impulsivity, and Cocaine Dependence Treatment - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 27, 2006

Last Updated Date

February 27, 2006

Start Date ^†

April 2001

Current Primary Outcome Measures ^†

The presence of cocaine metabolites in urine weekly.

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Retention rate and cocaine cravings weekly.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Serotonin, Impulsivity, and Cocaine Dependence Treatment

Official Title ^†

Serotonin, Impulsivity, and Cocaine Dependence Treatment

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Cocaine Dependence

Intervention ^†

Drug: citalopram

Study Arms / Comparison Groups

Publications *

Moeller FG, Schmitz JM, Steinberg JL, Green CM, Reist C, Lai LY, Swann AC, Grabowski J. Citalopram combined with behavioral therapy reduces cocaine use: a double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2007;33(3):367-78.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

120

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00297505

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

National Institute on Drug Abuse (NIDA)

Collaborators ^††

Investigators ^†

Principal Investigator:

Frederick G Moeller, M.D.

The University of Texas Health Science Center, Houston

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

February 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.