Official Title: “Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individual”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Topiramate
  • Topiramate up to 300 mg per day.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Topiramate

Primary Measures

• Compliance with study requirements which include both medication,and attendance at treatment sessions.
  • Time Frame: Throughout the study
    Safety Issue?: No

Secondary Measures

• adverse events, PE, lab results, withdrawal from alcohol,GGT, CDT,self-report measures of alcohol consumption - DDD and PDA,self-report measures of binge eating behavior-Binge eating episodes and Binge eating days.
  • Time Frame: Throughout the study
    Safety Issue?: Yes

Inclusion Criteria:

• Males and females that have given written informed consent.
• Good physical health as confirmed by a complete physical examination, vital signs including an EKG within normal limits, laboratory screening tests within acceptable parameters (see exclusion criteria), as well as a baseline psychiatric history
• Diagnosis of alcohol dependence and binge eating disorder.
• Subjects must have 3 or more binge days per week in the 2-week period prior to Screen.
• Subjects may have uncomplicated and well-controlled Type II diabetes and/or hypertension that has been well controlled by diet and/or oral agent therapy for at least 3 months prior to screen.
• Provide evidence of stable residence in the last month.
• The pregnancy test for females at intake must be negative. The female patients must either be sterile, post menopausal, or practicing an acceptable form of contraception.
• Literate in English and able to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatment.
• Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• Any current DSM-IV psychiatric diagnosis other than alcohol, nicotine dependence or binge eating disorder
• 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.
• Formal dietary behavioral therapy applies to therapy where the subject is diagnosed with an eating disorder and/or the health case provider is billing for costs of therapy (will be considered on a case-by-case basis if started within 30 days of Screen. Subjects engaged in dietary for obesity only (e.g., Jenny Craig, Weight Watchers, Overeater's Anonymous) should discontinue therapy prior to study entry (no washout applies).
• Clinically significant laboratory screening test.
• Clinically significant cardiovascular disease on a 12 lead EKG.
• Symptomatic coronary artery disease or peripheral vascular disease.
• Malignancy or history of malignancy within the past 5 years (except basal cell carcinoma).
• Clinically significant neurological disease.
• Clinically significant renal disease or impaired renal function as defined by subjects with an estimated creatinine clearance of less than 60 mL/min.
• Severe withdrawal symptoms which in the physicians' opinion requires inpatient treatment or severe or life-threatening adverse reactions to medications either in the past or during this clinical trial.
• Female patients who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
• Members of the same household.
• History of severe hypersensitivity to any medication or environmental allergens.
• Subjects with prior non-response to topiramate for the treatment of binge-eating and or alcohol disorder following an adequate trial of this medication
• Subjects who have been previously treated with topiramate for any reason and discontinued treatment due to an adverse event or due to a hypersensitivity reaction to topiramate.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Virginia

Overall Clinical Trial Officials and Contacts

Nassima Ait-Daoud, MD Principal Investigator University of Virginia, Department of Psychiatric Medicine  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300742

Study ID Number: HIC # 12069

ClinicalTrials.gov Identifier: NCT00300742

Health Authority: United States: Institutional Review Board

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