Citalopram for Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:

Clinical Trial of Serotonin Medication Combination in Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535573
• Other study ID #: 2P50DA009262-16A1
• Secondary ID: 2P50DA009262-16A
• Status: Completed
• Phase: Phase 2
• Start date: December 2010
• Est. completion date: July 2016

Study information

• Verified date: August 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	UT-Houston Behavioral and Biomedical Sciences Building	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Joy Schmitz	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test	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.	9 weeks
Secondary	Proportion of Cocaine-positive Urines Per Week	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.	9 weeks
Secondary	Number of Participants With Cocaine-negative Urines Collected During Treatment Period	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.	9 weeks
Secondary	Retention as Assessed by Number of Participants Remaining in Treatment		9 weeks