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

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00498628
First received: July 6, 2007
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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
Alcoholism
Alcohol Abuse
Drug: Quetiapine fumarate
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Drinks Per Drinking Day [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  • Drinks Per Day [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  • Percent Very Heavy Drinking Day [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  • Percent Subjects Abstinent [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  • Percent Subjects With no Heavy Drinking Day [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  • Drinking Consequences Score [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]
    DrInc Score

  • Craving Score [ Time Frame: Week 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
    PACS

  • Depression Score [ Time Frame: Week 4, 6, 8, 10, and 12 ] [ Designated as safety issue: No ]
    MADRS

  • Anxiety Score [ Time Frame: Weeks 4, 6, 8, 10 and 12 ] [ Designated as safety issue: No ]
    HAM-A

  • Sleep Quality Score [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index

  • Quality of Life Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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
Other Name: SEROQUEL XR
Placebo Comparator: 2
Medical management plus placebo comparator
Other: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498628

Locations
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
AstraZeneca
Investigators
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

Publications:
Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov 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: April 1, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
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 April 23, 2014