Citalopram for Cocaine Dependence

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trial of Serotonin Medication Combination in Cocaine Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Citalopram
* Drug: Citalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Citalopram low dose<br>Citalopram 20 mg | Drug: Citalopram<br>* 20 mg once per day for 9 weeks<br>|
| Active Comparator: Citalopram high dose<br>Citalopram 40 mg | Drug: Citalopram<br>* 40 mg per day for 9 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 0 mg per day for 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Retention as Assessed by Number of Participants Remaining in Treatment |  | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, citalopram, treatment, serotonin