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Sponsors and Collaborators: |
Medical University of South Carolina Forest Laboratories |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00466661 |
To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.
The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.
Condition | Intervention | Phase |
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Alcohol Dependence Bipolar Disorder |
Drug: Acamprosate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder |
Estimated Enrollment: | 40 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | March 2009 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bryan K Tolliver, M.D., Ph.D | (843) 792-5205 | tollive@musc.edu |
Contact: Delisa G Brown, BA | (843) 792-0572 |
United States, South Carolina | |
Institute of Psychiatry, Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Bryan K Tolliver, M.D., Ph.D. 843-792-5205 tollive@musc.edu |
Principal Investigator: | Bryan K Tolliver, M.D., Ph.D. | Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina |
Study Director: | Kathleen T Brady, M.D., Ph.D. | Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina |
Study ID Numbers: | HR#16928 |
Study First Received: | April 25, 2007 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00466661 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acamprosate Alcoholism Bipolar disorder Comorbidity Craving Depression |
GABA Glutamate Mania Pharmacotherapy Withdrawal |
Depression Bipolar Disorder Disorders of Environmental Origin Depressive Disorder Acamprosate Affective Disorders, Psychotic Mental Disorders |
Alcoholism Substance-Related Disorders Mood Disorders Alcohol-Related Disorders Psychotic Disorders Ethanol |
Disease Bipolar Disorder Disorders of Environmental Origin Pharmacologic Actions Acamprosate Affective Disorders, Psychotic Pathologic Processes Mental Disorders |
Therapeutic Uses Alcoholism Substance-Related Disorders Mood Disorders Alcohol-Related Disorders Central Nervous System Agents Alcohol Deterrents |