Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individuals

Condition(s) targeted: Alcohol Dependence; Binge Eating

Intervention: Topiramate (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Virginia

Official(s) and/or principal investigator(s):
Nassima Ait-Daoud, MD, Principal Investigator, Affiliation: University of Virginia, Department of Psychiatric Medicine

Overall contact:
Mindy Borszich, BA, Phone: 1-888-882-2345, Email: uvacare@virginia.edu

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.

Official title: Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individual

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

Primary outcome: Compliance with study requirements which include both medication,and attendance at treatment sessions.

Secondary outcome: 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.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Mindy Borszich, BA, Phone: 1-888-882-2345, Email: uvacare@virginia.edu

UVA CARE, Charlottesville, Virginia 22911, United States; Recruiting
Nassima Ait-Daoud, MD, Principal Investigator

UVA CARE Richmond, Richmond, Virginia 23294, United States; Recruiting
Nassima Ait-Daoud, MD, Principal Investigator

UVA CARE Website

Starting date: March 2006
Ending date: December 2009
Last updated: May 15, 2008