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Sponsored by: |
University of Virginia |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00300742 |
The purpose of this study is to test the feasibility of using topiramate to reduce binge eating and drinking episodes in alcohol dependent individuals with comorbid binge eating disorder.
Condition | Intervention | Phase |
---|---|---|
Alcohol Dependence Binge Eating |
Drug: Topiramate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individual |
Enrollment: | 5 |
Study Start Date: | March 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Topiramate: Experimental |
Drug: Topiramate
Topiramate up to 300 mg per day.
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Research has shown an alarming coincidence of binge eaters also reporting serious alcohol abuse. Evidence has shown this population to have higher rates of psychiatric comorbidity, higher caloric intakes during meals, higher rates of tobacco use, more frequent binge episodes, and an earlier age of onset for binge eating and alcohol abuse. It is believed that topiramate may reduce binge eating and has been found helpful in reducing the cravings associated with alcohol consumption.
This study is to test the feasibility of administering topiramate to individuals with alcohol dependence and binge eating disorder. This will involve determining the adequacy of the amount of assessment and scheduled visits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects who have begun to receive formal psychotherapy (cognitive-behavioral therapy, interpersonal therapy, dietary behavioral therapy*, or self-guided cognitive-behavioral) for binge-eating disorder or any other psychiatric disorder within 30 days prior to Screen. Subjects who have been engaged in formal psychotherapy for a longer period of time and plan to maintain therapy will be judged on a case-by-case basis.
United States, Virginia | |
UVA CARE | |
Charlottesville, Virginia, United States, 22911 | |
UVA CARE Richmond | |
Richmond, Virginia, United States, 23294 |
Principal Investigator: | Nassima Ait-Daoud, MD | University of Virginia, Department of Psychiatric Medicine |
Responsible Party: | University of Virginia ( Bankole Johnson, DSc, M.D., Ph.D. ) |
Study ID Numbers: | HIC # 12069 |
Study First Received: | March 7, 2006 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00300742 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
drinking eating obesity alcohol binge eating |
Obesity Signs and Symptoms, Digestive Disorders of Environmental Origin Hyperphagia Bulimia Nervosa Signs and Symptoms Mental Disorders |
Alcoholism Bulimia Substance-Related Disorders Topiramate Alcohol-Related Disorders Eating Disorders Ethanol |
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |