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

NCT00300742 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 12069
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alcohol Dependence; Binge Eating

Keywords

drinking; eating; obesity; alcohol; binge eating

Outcome Measures

Primary Outcomes (5)

• Compliance With Study Requirements: Attendance at Treatment Sessions

  up to 12 weeks

• Mean Drinks Per Day at Baseline vs. Visit 12

  Mean drinks per day at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary

  up to 24 weeks

• Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12

  Mean percent days abstinent per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary

  up to 24 weeks

• Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12

  Mean binge eating episodes per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary

  up to 24 weeks

• Compliance With Study Requirements: Topiramate Level

  Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day

  up to 12 weeks

Study Arms (1)

Topiramate

EXPERIMENTAL

Drug: Topiramate Other Name for Topiramate: Topamax

Drug: Topiramate

Interventions

Topiramate DRUG

Topiramate up to 300 mg per day.

Also known as: Topamax

Topiramate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females that have given written informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (2)

UVA CARE

Charlottesville, Virginia, 22911, United States

Location

UVA CARE Richmond

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Alcoholism; Bulimia; Obesity

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Dr. Nassima Ait-Daoud
• Organization: UVA Center for Addiction Research and Education

uvacare@virginia.edu

434-243-0541

Study Officials

• Nassima Ait-Daoud, MD

  University of Virginia, Department of Psychiatric Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of UVA Center for Addiction Research and Education

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 9, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 12, 2017
• Results First Posted: May 11, 2017

Record last verified: 2012-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)