Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
Completed · Phase 2 · Has a placebo group
Conditions studied: Alcoholism, Alcohol Abuse
In brief
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.
Key facts
- Study ID
- NCT00498628
- Run by
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- People needed
- 224
- Starts
- 2007-12-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2019-03-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Please contact site for additional information.
Where it is running
- Boston University School of Medicine, Psychiatry Clinical Studies Unit — Boston, Massachusetts, United States
- Dartmouth Medical School, Dept. of Psychiatry — Lebanon, New Hampshire, United States
- University of Pennsylvania, Treatment Research Center — Philadelphia, Pennsylvania, United States
- Brown University Center for Alcohol and Addiction Studies — Providence, Rhode Island, United States
- White River Junction VA Medical Center — White River Junction, Vermont, United States
- University of Virginia, Dept. of Psychiatric Medicine — Charlottesville, Virginia, United States
- University of Virginia — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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