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| Sponsor: | University of Virginia |
|---|---|
| Information provided by (Responsible Party): | Nassima Ait-Daoud Tiouririne, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00300742 |
Purpose
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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: Topiramate |
Drug: Topiramate
Topiramate up to 300 mg per day.
Other Name: Topamax
|
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.
Eligibility| 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.
Contacts and Locations| 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 |
More Information
| Responsible Party: | Nassima Ait-Daoud Tiouririne, Associate Professor, Director of UVA Center for Addiction Research and Education, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00300742 History of Changes |
| Other Study ID Numbers: | 12069 |
| Study First Received: | March 7, 2006 |
| Last Updated: | February 6, 2012 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
drinking eating obesity alcohol binge eating |
|
Alcoholism Bulimia Bulimia Nervosa Binge-Eating Disorder Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms |
Eating Disorders Topiramate Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |