Brain Function and Structure in Cocaine Dependence

Study Overview
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Brief Summary
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The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.

Detailed Description
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The Specific Aims of this project are: Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects. Hypothesis related to Aim 1: Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group. Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects. Hypothesis related to Aim 2: Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation from the cocaine Stroop task will be significantly greater for the citalopram group than the placebo group.

Official Title
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Brain Function and Structure in Cocaine Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Citalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment. Exclusion Criteria: Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe Significant current suicidal or homicidal ideation Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG) Taking CNS active concomitant medications Taking medications known to have significant drug interactions with the study medication Having conditions of probation or parole requiring reports of drug use to officers of the court Impending incarceration Pregnant or breast feeding for female patients Inability to read, write, or speak English Having plans to leave the immediate geographical area within 3 months Unwillingness or not competent to sign a written informed consent form Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV. Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication (Citalopram 20mg)<br>Citalopram (20mg dose) | Drug: Citalopram<br>* 20 mg or 40 mg daily for 8 weeks<br>* Other names: Citalopram HBr;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo daily for 8 weeks<br>|
| Experimental: Medication (Citalopram 40mg)<br>Citalopram 40mg dose | Drug: Citalopram<br>* 20 mg or 40 mg daily for 8 weeks<br>* Other names: Citalopram HBr;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Use/Treatment Effectiveness Score (TES) | Number of benzoylecgonine negative urines divided by the total number of urines collected | 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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substance abuse, cocaine, impulsivity, serotonin, MRI