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Seroquel for Frequent, Heavy Drinkers
This study is currently recruiting participants.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA), November 2008
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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

MedlinePlus related topics: Alcoholism
Drug Information available for: Quetiapine Quetiapine fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Phase II Double-Blind, Placebo-Controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2)

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

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 abstinant 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 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Seroquel
Drug: Seroquel
400 mg/day
2: Placebo Comparator
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 SCID-IV {First, 1996 #34}.
  • Meets the following drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}: a. drank to intoxication 15 of the previous 30 days prior to entering the trial, defined in the ASI as drinking to achieve a "high or buzz" and operationally defined as 3 or more drinks in one sitting of 1-2 hours. b. reports an average of 12 standard drinks per drinking day for men (10 for women) in the 30 days prior to entering the trial [Note: This level of drinking predicted a positive response to quetiapine in our pilot trial].
  • Three consecutive days of abstinence from alcohol, determined by self-reports and confirmed by a negative breathalyzer tests immediately before the day of randomization, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) {Sullivan, 1989 #97} score below eight on the day of 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), tests positive on the urine drug screen in the screening week (one retest allowed).
  • 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).
  • Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. For example, bipolar affective disorder, schizophrenia or any other psychotic disorder, or organic mental disorder; 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 (with the exception of detoxification medications or benadryl used sparingly for sleep).
  • 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.
  • Has known hypersensitivity to antipsychotics.
  • Has participated in any investigational drug trial within 30 days prior to the study.
  • A history of seizures.
  • 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
Investigators
Principal Investigator: Kyle M Kampman, M.D. University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania Treatment Research Cener ( Kyle Kampman, M.D. )
Study ID Numbers: 807057 - Kampan_AA016553, NIH Grant 1R01AA016553-01A1
Study First Received: May 6, 2008
Last Updated: November 4, 2008
ClinicalTrials.gov Identifier: NCT00674765  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Quetiapine
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009