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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 |
---|---|---|
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 |
---|---|
1: Experimental
Seroquel
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Drug: Seroquel
400 mg/day
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
400 mg/day
|
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:
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: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00674765 |
Health Authority: | United States: Food and Drug Administration |
Quetiapine Mental Disorders Alcoholism |
Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |