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Sponsors and Collaborators: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) University of Miami |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00302133 |
The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder Alcohol Dependence |
Drug: naltrexone add on to open label valproate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Optimizing Pharmacotherapy for Bipolar Alcoholics |
Estimated Enrollment: | 104 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Naltrexone add on to valproate: Experimental
valproate open label plus double blind naltrexone hydrochloride
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Drug: naltrexone add on to open label valproate
naltrexone 50 mg/day for 12 weeks add on to open label valproate
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Bipolar disorder has the highest rate of association with alcohol and other substance use disorders. This complex clinical presentation is asociated with severe disabilities,morbidity and heightened risk for suicide. There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population. This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder. All participants receive supportive psychosocial treatment.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ihsan M Salloum, MD, MPH | 305-243-7931 | isalloum@med.miami.edu |
Contact: Carleen Robinson, LCSW, ABD | 305-243-1298 | CRobins2@med.miami.edu |
United States, Florida | |
University of Miami Miller School of Medicine | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Carleen Robinson, LSCW, ABD 305-243-1298 CRobins2@med.miami.edu | |
Contact: Alicia Frasca, CCRP 305-243-7951 afrasca@med.miami.edu | |
Principal Investigator: Ihsan M. Salloum, MD, MPH |
Principal Investigator: | Ihsan M Salloum, MD, MPH | University of Miami Miller School of Medicine |
Responsible Party: | University of Miami ( Ihsan M. Salloum, MD, MPH (Principal Investigator) ) |
Study ID Numbers: | RO1-AA015385-01 -Salloum |
Study First Received: | March 9, 2006 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00302133 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Narcotic Antagonists Psychotropic Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Antimanic Agents Valproic Acid |
Affective Disorders, Psychotic Mental Disorders Alcoholism Naltrexone Substance-Related Disorders Mood Disorders Alcohol-Related Disorders Psychotic Disorders Peripheral Nervous System Agents Anticonvulsants |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Narcotic Antagonists Psychotropic Drugs Disorders of Environmental Origin Valproic Acid Affective Disorders, Psychotic Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Alcohol-Related Disorders |
Tranquilizing Agents Bipolar Disorder Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Pharmacologic Actions Naltrexone Alcoholism Mood Disorders GABA Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |