Seroquel for Frequent, Heavy Drinkers

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674765
• Other study ID #: 807057 - Kampan_AA016553
• Secondary ID: NIH Grant 1R01AA
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2008
• Last updated: September 16, 2014
• Start date: January 2008
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alcoholic Intoxication
• Alcoholism

Intervention

Drug:
• Seroquel
400 mg/day
• Placebo
400 mg/day

Locations

Country	Name	City	State
United States	University of Pennsylvania, Treatment Research Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No