Seroquel for Frequent, Heavy Drinkers

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

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.

Study Overview

• Status: Completed
• Conditions: Alcoholism
• Intervention / Treatment: Drug: Seroquel; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania, Treatment Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; 400 mg/day
Experimental: 1; Seroquel	Drug: Seroquel; 400 mg/day; Other Names: quetiapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Kyle M Kampman, M.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 7, 2008
• First Posted (Estimate): May 8, 2008

Study Record Updates

• Last Update Posted (Estimate): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Alcoholic Intoxication; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: 807057 - Kampan_AA016553; NIH Grant 1R01AA016553-01A1