Seroquel for Frequent, Heavy Drinkers

NCT ID: NCT00674765

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2014-01-31

Brief 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.

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.

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Seroquel

Group Type: EXPERIMENTAL

Seroquel

Intervention Type: DRUG

400 mg/day

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

400 mg/day

Interventions

Seroquel

400 mg/day

Intervention Type: DRUG

Placebo

400 mg/day

Intervention Type: DRUG

Other Intervention Names

quetiapine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle M Kampman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NIH Grant 1R01AA016553-01A1

Identifier Type: -

Identifier Source: secondary_id

807057 - Kampan_AA016553

Identifier Type: -

Identifier Source: org_study_id