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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00300742
Recruitment Status : Completed
First Posted : March 9, 2006
Results First Posted : May 11, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Binge Eating Drug: Topiramate Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individual
Study Start Date : March 2006
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Topiramate
Drug: Topiramate Other Name for Topiramate: Topamax
Drug: Topiramate
Topiramate up to 300 mg per day.
Other Name: Topamax


Outcome Measures

Primary Outcome Measures :
  1. Compliance With Study Requirements: Attendance at Treatment Sessions [ Time Frame: up to 12 weeks ]
  2. Mean Drinks Per Day at Baseline vs. Visit 12 [ Time Frame: up to 24 weeks ]
    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

  3. Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12 [ Time Frame: up to 24 weeks ]
    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

  4. Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12 [ Time Frame: up to 24 weeks ]
    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

  5. Compliance With Study Requirements: Topiramate Level [ Time Frame: up to 12 weeks ]
    Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300742


Locations
United States, Virginia
UVA CARE
Charlottesville, Virginia, United States, 22911
UVA CARE Richmond
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
University of Virginia
Investigators
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
First Posted: March 9, 2006    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: July 12, 2017
Last Verified: February 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nassima Ait-Daoud Tiouririne, University of Virginia:
drinking
eating
obesity
alcohol
binge eating

Additional relevant MeSH terms:
Alcoholism
Binge-Eating Disorder
Bulimia
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Feeding and Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Ethanol
Topiramate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents