Seroquel for Frequent, Heavy Drinkers - Full Text View

Sponsor:	University of Pennsylvania
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00674765

Purpose

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.

Condition	Intervention	Phase
Alcoholism	Drug: Seroquel Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase II Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2)

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

TimeLine Follow Back (TLFB) to measure percent abstinent days and percent heavy drinking days during the medication/placebo phase [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

TLFB data on percent of heavy drinking days and percent of days abstinent during the follow-up phase; Comparison of HAM A, HAM D and ISI scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Seroquel	Drug: Seroquel 400 mg/day Other Name: quetiapine
Placebo Comparator: 2 Placebo	Drug: Placebo 400 mg/day

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and females, 18-70 years old.
Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}.
Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}:
Three consecutive days of abstinence from alcohol immediately before randomization
Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
Speaks, understands, and prints in English.

Exclusion Criteria:

Has evidence of dependence on a substance other than alcohol (except nicotine and marijuana).
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.
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.
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.
Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication.
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.
Has known hypersensitivity to antipsychotics.
Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization.
A history of seizure disorder.
The presence of cataracts.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674765

Contacts

Contact: Kyle M Kampman, MD

215-222-3200 ext 109

kampman_k@mail.trc.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania, Treatment Research Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Donna Simpson 215-222-3200 ext 158 Simpson_D@mail.trc.upenn.edu
Principal Investigator: Kyle M Kampman, MD

Sponsors and Collaborators

University of Pennsylvania

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Kyle M Kampman, M.D.

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Kyle Kampman, M.D., University of Pennsylvania Treatment Research Cener
ClinicalTrials.gov Identifier:	NCT00674765 History of Changes
Other Study ID Numbers:	807057 - Kampan_AA016553, NIH Grant 1R01AA016553-01A1
Study First Received:	May 6, 2008
Last Updated:	August 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alcoholic Intoxication
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012