Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-uptake Inhibitor (SSRI)

Study Overview
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Brief Summary
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This study is being done to determine if citalopram is safe and effective in the treatment of alcohol dependence. A second purpose is to evaluate whether alcohol dependent individuals who differ in a specific genetic marker respond differently to citalopram. Citalopram is a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of depression. It belongs to a category of medications called selective serotonin re-uptake inhibitors or SSRIs. The U.S. FDA has not approved citalopram for the treatment of alcohol dependence. Therefore, it is being used off-label in this study.

Detailed Description
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Relapse to alcoholism remains a vexing clinical and national health problem. Efforts to match alcohol dependent patients to specific treatments based on their clinical characteristics have produced mixed results. Pharmacogenetics (the study of genetic influences on therapeutic response to drugs) offers a powerful new tool to match specific elements of an individual patient's complex genetic blueprint with targeted pharmacotherapies to which that individual may optimally respond. The purpose of this proposed research is to apply pharmacogenetic techniques to predict which alcohol dependent patients will respond favorably to a trial of a selective serotonin re-uptake inhibitor (SSRI) for the prevention of alcoholism relapse. Our central hypothesis is that genetic differences affecting serotonin transporter function will influence an alcohol dependent individual's treatment response to the SSRI, citalopram. To test this hypothesis, we will perform a 14-week, randomized, double blind, parallel group comparison of citalopram and placebo in treatment seeking outpatients who meet DSM-IV criteria for alcohol dependence. All subjects will receive a single Motivational Interview and 9 brief sessions of a manual-guided Compliance Enhancement Therapy designed to promote treatment adherence and enhance motivation to quit or cut down on drinking. Post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks. Subjects' DNA will be genotyped to determine allelic variants in the promoter region of the serotonin transporter gene that have been found to markedly affect serotonin reuptake and influence treatment responsiveness to SSRIs.

Official Title
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Predicting Alcoholics' Treatment Responses to an SSRI

Conditions
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Alcoholism, Alcohol Abuse

Intervention / Treatment
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* Drug: Citalopram + MI
* Behavioral: Placebo + MI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with a diagnosis of DSM-IV alcohol dependence Not morbidly obese or underweight Express desire to quit or cut down on drinking for duration of trial Exclusion Criteria: Clinically significant laboratory evidence of diseases Have active psychological disorders other than alcoholism

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: 1<br>citalopram | Drug: Citalopram + MI<br>* 14-week citalopram treatment + Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.<br>* Other names: celexa;|
| Placebo Comparator: 2<br>Placebo | Behavioral: Placebo + MI<br>* placebo + single Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent days abstinent |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent heavy drinking days |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical trial, Alcoholism, Alcohol, Pharmacogenetics, Citalopram, Genotype, Therapy compliance, Serotonin inhibitor, Alcoholism/alcohol abuse therapy