Seroquel for Frequent, Heavy Drinkers

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.

Detailed Description
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This trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are frequent heavy drinkers.

Official Title
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A Phase II Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2)

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: Seroquel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females, 18-70 years old. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}. Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}: Three consecutive days of abstinence from alcohol immediately before randomization Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits. Speaks, understands, and prints in English. Exclusion Criteria: Has evidence of dependence on a substance other than alcohol (except nicotine and marijuana). Tests positive on the urine drug screen during the screening weeks (one retest allowed). Subjects whose urine drug screen tests positive for benzodiazepines will be allowed to randomize, at the discretion of the PI, if they are known to be physician-prescribed for detox purposes. Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (>1.3), with associated elevations of AST and ALT above normal limits. Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. Has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease. Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication. Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the patient is of child-bearing potential, meaning has not had a hysterectomy or is in menopause, meaning 50 or over and has not had a menstrual cycle in 12 months. Has known hypersensitivity to antipsychotics. Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization. A history of seizure disorder. The presence of cataracts.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Seroquel | Drug: Seroquel<br>* 400 mg/day<br>* Other names: quetiapine;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* 400 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase | The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm. | 12 weeks |