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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: August 8, 2014
Last verified: August 2014

July 6, 2007
August 8, 2014
December 2007
August 2009   (final data collection date for primary outcome measure)
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.
Percentage of Days of Heavy Drinking [ Time Frame: Weeks 3 - 11 ]
Complete list of historical versions of study NCT00498628 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
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.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alcoholism
  • Alcohol Abuse
  • Drug: Quetiapine fumarate
    Quetiapine fumarate- taken daily, for 12 weeks
    Other Name: SEROQUEL XR
  • Other: Placebo
    Placebo
  • Experimental: 1
    Quetiapine fumarate plus medical management
    Intervention: Drug: Quetiapine fumarate
  • Placebo Comparator: 2
    Medical management plus placebo comparator
    Intervention: Other: Placebo
Litten RZ, Fertig JB, Falk DE, Ryan ML, Mattson ME, Collins JF, Murtaugh C, Ciraulo D, Green AI, Johnson B, Pettinati H, Swift R, Afshar M, Brunette MF, Tiouririne NA, Kampman K, Stout R; NCIG 001 Study Group. A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients. Alcohol Clin Exp Res. 2012 Mar;36(3):406-16. doi: 10.1111/j.1530-0277.2011.01649.x. Epub 2011 Sep 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
March 2010
August 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00498628
NIAAA_DTRR-2007-LITTEN-01
Yes
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Department of Veterans Affairs
  • National Institute on Drug Abuse (NIDA)
  • AstraZeneca
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)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP