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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00674765 |
The purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.
Condition | Intervention | Phase |
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Alcoholism |
Drug: Seroquel Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2) |
Estimated Enrollment: | 180 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Seroquel
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Drug: Seroquel
400 mg/day
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2: Placebo Comparator
Placebo
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Drug: Placebo
400 mg/day
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This trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are frequent heavy drinkers.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the SCID-IV {First, 1996
Meets the following drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992
Exclusion Criteria:
Contact: Kyle M Kampman, MD | 215-222-3200 ext 109 | kampman_k@mail.trc.upenn.edu |
United States, Pennsylvania | |
University of Pennsylvania, Treatment Research Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Donna Simpson 215-222-3200 ext 158 Simpson_D@mail.trc.upenn.edu | |
Principal Investigator: Kyle M Kampman, MD |
Principal Investigator: | Kyle M Kampman, M.D. | University of Pennsylvania |
Responsible Party: | University of Pennsylvania Treatment Research Cener ( Kyle Kampman, M.D. ) |
Study ID Numbers: | 807057 - Kampan_AA016553, NIH Grant 1R01AA016553-01A1 |
Study First Received: | May 6, 2008 |
Last Updated: | July 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00674765 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Quetiapine Tranquilizing Agents Mental Disorders Alcoholism Psychotropic Drugs |
Substance-Related Disorders Central Nervous System Depressants Disorders of Environmental Origin Alcohol-Related Disorders Antipsychotic Agents |
Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions |
Quetiapine Mental Disorders Therapeutic Uses Alcoholism Substance-Related Disorders Alcohol-Related Disorders Central Nervous System Agents |