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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Collaborators: AstraZeneca; National Institute on Drug Abuse (NIDA); US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Ethanol; Quetiapine Fumarate

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:

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