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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Quetiapine fumarate
  • Quetiapine fumarate- taken daily, for 12 weeks
• Other: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Quetiapine fumarate plus medical management
• Placebo Comparator: 2
  • Medical management plus placebo comparator

Primary Measures

• Percentage of Days of Heavy Drinking
  • Time Frame: Weeks 3 - 11
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Overall Clinical Trial Officials and Contacts

Raye Z. Litten, PhD Study Director National Institute on Alcohol Abuse and Alcoholism (NIAAA)  

Overall Contact: Megan Ryan, BS 301.443.4225 fitzpatrickm@mail.nih.gov

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00498628

Study ID Number: NIAAA_DTRR-2007-LITTEN-01

ClinicalTrials.gov Identifier: NCT00498628

Health Authority: United States: Food and Drug Administration