Seroquel for Frequent, Heavy Drinkers

University of Pennsylvania

Status and phase: Completed; Phase 2

Conditions: Alcoholism

Treatments: Drug: Placebo; Drug: Seroquel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00674765

NIH Grant 1R01AA016553-01A1

807057 - Kampan_AA016553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Seroquel

Treatment:

Drug: Seroquel

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo