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Seroquel for Frequent, Heavy Drinkers

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism

Intervention: Seroquel (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Kyle M Kampman, M.D., Principal Investigator, Affiliation: University of Pennsylvania


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase

Detailed description: 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.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria: 1. Male and females, 18-70 years old. 2. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}. 3. Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}: 4. Three consecutive days of abstinence from alcohol immediately before randomization 5. Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits. 6. Speaks, understands, and prints in English. Exclusion Criteria: 1. Has evidence of dependence on a substance other than alcohol (except nicotine and marijuana). 2. 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. 3. 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. 4. 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. 5. Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication. 6. 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. 7. Has known hypersensitivity to antipsychotics. 8. Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization. 9. A history of seizure disorder. 10. The presence of cataracts.

Locations and Contacts

University of Pennsylvania, Treatment Research Center, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: January 2008
Last updated: September 16, 2014

Page last updated: August 23, 2015

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