Seroquel for Frequent, Heavy Drinkers
Condition: Alcoholism
MeSH terms: Alcoholism; Alcoholic Intoxication
Intervention: Seroquel; Placebo
Intervention description: 400 mg/day; 400 mg/day
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.