Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Study Overview
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Brief Summary
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The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

Detailed Description
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This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.

Official Title
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Combining Medications Treatment for Alcoholism

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: ondansetron + cognitive behavioral therapy
* Drug: topiramate + cognitive behavioral therapy
* Drug: Placebo + cognitive behavioral therapy
* Drug: ondansetron + topiramate + cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days. Provide a written, informed consent. Good physical health and must weigh within at least 40 kg and no more than 140 kg. Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately. Willingness to participate in behavioral treatments for alcoholism. Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months. Exclusion Criteria: Please contact site for additional information

Ages Eligible for Study
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Minimum Age: 18 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br>Ondansetron + cognitive behavioral therapy | Drug: ondansetron + cognitive behavioral therapy<br>* ondansetron (4 mcg/kg b.i.d)<br>* Other names: Zofran;|
| Experimental: Topiramate<br>Topiramate + cognitive behavioral therapy | Drug: topiramate + cognitive behavioral therapy<br>* topiramate (up to 300 mg/day)<br>* Other names: Topamax;|
| Placebo Comparator: Placebo<br>Placebo + cognitive behavioral therapy | Drug: Placebo + cognitive behavioral therapy<br>* placebo<br>* Other names: sugar pill;|
| Experimental: Ondansetron + Topiramate<br>Ondansetron + Topiramate + cognitive behavioral therapy | Drug: ondansetron + topiramate + cognitive behavioral therapy<br>* ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)<br>* Other names: zofran, topamax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption | Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT | Throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors | Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM | Throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol addiction, alcoholism