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Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency

This study has been completed.
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier:
First received: July 6, 2007
Last updated: June 17, 2015
Last verified: June 2015
The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.

Condition Intervention Phase
Alcohol Abuse
Drug: Quetiapine fumarate
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Quetiapine Fumarate Extended Release for the Treatment of Alcohol Dependence in Very Heavy Drinkers.

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Percent Heavy Drinking Days [ Time Frame: Weeks 3 - 11 ]
    A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.

Secondary Outcome Measures:
  • Percent Days Abstinent [ Time Frame: 3-11 ]
  • Drinks Per Drinking Day [ Time Frame: 3-11 ]
  • Drinks Per Day [ Time Frame: 3-11 ]
  • Percent Very Heavy Drinking Day [ Time Frame: 3-11 ]
  • Percent Subjects Abstinent [ Time Frame: 3-11 ]
  • Percent Subjects With no Heavy Drinking Day [ Time Frame: 3-11 ]
  • Drinking Consequences Score [ Time Frame: Weeks 6 and 12 ]
    DrInc Score

  • Craving Score [ Time Frame: Week 4, 6, 8, 10, 12 ]

  • Depression Score [ Time Frame: Week 4, 6, 8, 10, and 12 ]

  • Anxiety Score [ Time Frame: Weeks 4, 6, 8, 10 and 12 ]

  • Sleep Quality Score [ Time Frame: Weeks 4, 8 and 12 ]
    Pittsburgh Sleep Quality Index

  • Quality of Life Score [ Time Frame: Week 12 ]
    Quality of Life SF - 12

Enrollment: 224
Study Start Date: December 2007
Study Completion Date: March 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Quetiapine fumarate plus medical management
Drug: Quetiapine fumarate
Quetiapine fumarate- taken daily, for 12 weeks
Placebo Comparator: 2
Medical management plus placebo comparator
Other: Placebo

Detailed Description:

This study will investigate quetiapine fumarate XR (SEROQUEL XR®), a dibenzothiazepine derivative, as a potential medication for treating alcohol dependence. The immediate release form of quetiapine fumarate, SEROQUEL XR®, is approved by the FDA for treatment of schizophrenia and acute manic episodes associated with bipolar disorder. The extended release formulation (SEROQUEL XR®) is also approved by the FDA and is undergoing clinical investigation for the treatment of major depressive disorders, schizophrenia, generalized anxiety disorder, and alcohol dependence.

Treatment with other atypical antipsychotics such as clozapine and olanzapine has resulted in decreases in alcohol use in alcohol dependent patients with and without comorbid psychiatric diagnoses. Quetiapine, like clozapine, appears to have efficacy in reducing drug and alcohol use among alcoholics and drug dependent patients with co-morbid psychiatric illness.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Between the ages of 18 and 65 years old
  • DSM-IV diagnosis of current alcohol dependence as supported by SCID Module E
  • Report "very heavy" drinking (10 or more drinks per drinking day for men or 8 or more drinks per drinking day for women) at least 40% of the days during the interval from day 31 to 90 prior to the initial screening visit (i.e. a total of 24 days of this 60-day period), with at least one day of "very heavy" drinking occurring within the last 2 weeks before screening
  • Seeking treatment for alcohol dependence and desire reduction or cessation of drinking
  • Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
  • Females of child bearing potential must agree to use of at least one approved method of birth control, or must be surgically sterile or postmenopausal
  • Able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits
  • Able to understand written and oral instructions in English and to complete the questionnaires required by the protocol
  • Can complete all psychological assessments required at screening and baseline
  • Able to provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to study site, and have no plans to move within the next 3 months or unresolved legal problems; must provide contact information of family member, spouse, or significant other who can contact subject in case of missed appointment
  • Breath alcohol concentration (BAC) equal to 0.00 when s/he signed the informed consent document
  • Must have an absolute neutrophil count of 1.5 x 109/L or greater.

Exclusion Criteria:

Please contact site for additional information.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00498628

United States, Massachusetts
Boston University School of Medicine, Psychiatry Clinical Studies Unit
Boston, Massachusetts, United States, 02118
United States, New Hampshire
Dartmouth Medical School, Dept. of Psychiatry
Lebanon, New Hampshire, United States, 03755
United States, Pennsylvania
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 12906
United States, Vermont
White River Junction VA Medical Center
White River Junction, Vermont, United States, 05009
United States, Virginia
University of Virginia, Dept. of Psychiatric Medicine
Charlottesville, Virginia, United States, 22908
University of Virginia
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
Study Director: Raye Z. Litten, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Margaret E. Mattson, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Joanne Fertig, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier: NCT00498628     History of Changes
Other Study ID Numbers: NIAAA_DTRR-2007-LITTEN-01
Study First Received: July 6, 2007
Results First Received: April 25, 2012
Last Updated: June 17, 2015

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcohol dependence

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Quetiapine Fumarate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs processed this record on April 21, 2017