Citalopram for Cocaine Dependence

This study is currently recruiting participants.

Verified February 2012 by The University of Texas Health Science Center, Houston

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Joy Schmitz, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT01535573

First received: October 24, 2011

Last updated: February 14, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 24, 2011

Last Updated Date

February 14, 2012

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Abstinence [ Time Frame: over 9 weeks of treatment ] [ Designated as safety issue: No ]

The proportion of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (weeks 8-9).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01535573 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cocaine Use Days [ Time Frame: over 9 weeks of treatment ] [ Designated as safety issue: No ]
Weekly fraction of cocaine use days.
Cocaine-negative Urines [ Time Frame: over 9 weeks of treatment ] [ Designated as safety issue: No ]
Percent negative urines collected during treatment period
Retention in Treatment [ Time Frame: over 9 weeks of treatment ] [ Designated as safety issue: No ]
Proportion of subjects remaining in treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Citalopram for Cocaine Dependence

Official Title ^ICMJE

Clinical Trial of Serotonin Medication Combination in Cocaine Dependence

Brief Summary

This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Cocaine Dependence

Intervention ^ICMJE

Drug: Citalopram
20 mg once per day for 9 weeks
Drug: Citalopram
40 mg per day for 9 weeks
Drug: Placebo
0 mg per day for 9 weeks

Study Arm (s)

Active Comparator: Citalopram low dose
Citalopram 20 mg

Intervention: Drug: Citalopram
Active Comparator: Citalopram high dose
Citalopram 40 mg

Intervention: Drug: Citalopram
Placebo Comparator: Placebo
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

125

Completion Date

Not Provided

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

between 18 and 60 years of age
meet DSM-IV criteria for current cocaine dependence
be in acceptable health on the basis of interview, medical history and physical exam
able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria:

diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
medical conditions contraindicating citalopram pharmacotherapy
taking medications known to have significant drug interactions with the study medication
pregnant or nursing for female patients
having plans to leave the immediate geographical area within 3 months

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jessica Vincent, BS	7135003784	Jessica.Vincent@uth.tmc.edu
Contact: Fallon Brewer, BS	7135003784	Fallon.Brewer@uth.tmc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01535573

Other Study ID Numbers ^ICMJE

2P50DA009262-16A1

Has Data Monitoring Committee

Yes

Responsible Party

Joy Schmitz, The University of Texas Health Science Center, Houston

Study Sponsor ^ICMJE

Joy Schmitz

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Joy M Schmitz, Ph.D.

University of Texas at Houston

Information Provided By

The University of Texas Health Science Center, Houston

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top