Citalopram for Cocaine Dependence

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: Citalopram; Drug: Placebo

• Registration Number: NCT01535573
• Lead Sponsor: Joy Schmitz

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 available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2020-08
• Results First Submitted: 2020-08-13
• Results First Submitted QC: 2020-08-13
• Last Update Submitted: 2020-08-29
• Results First Posted: 2020-08-31
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• between 18 and 60 years of age
• meet Diagnostic and Statistical Manual 4 (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Citalopram low dose	Citalopram	Citalopram 20 mg
Citalopram high dose	Citalopram	Citalopram 40 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test	9 weeks	Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.

Secondary Outcome Measures

Name	Time	Method
Proportion of Cocaine-positive Urines Per Week	9 weeks	Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use.
Retention as Assessed by Number of Participants Remaining in Treatment	9 weeks
Number of Participants With Cocaine-negative Urines Collected During Treatment Period	9 weeks	Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.

Trial Locations

Locations (1)

UT-Houston Behavioral and Biomedical Sciences Building; 🇺🇸 Houston, Texas, United States