Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individuals
Condition: Alcohol Dependence; Binge Eating
MeSH terms: Bulimia; Alcoholism; Binge-Eating Disorder
Intervention: Topiramate
Intervention description: Topiramate up to 300 mg per day.
Intervention MeSH terms: Topiramate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: drinking; eating; obesity; alcohol; binge eating

Summary:

      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.
    

Eligibility criteria:

        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.