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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Experimental | Drug: Topiramate Other Name for Topiramate: Topamax |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | Topiramate up to 300 mg per day. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Nassima Ait-Daoud, MD | University of Virginia, Department of Psychiatric Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA CARE | Charlottesville | Virginia | 22911 | United States | ||
| UVA CARE Richmond |
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Participants were recruited in Charlottesville and Richmond between September 2006 to February 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate/BBCET | Escalating dose of up to 300 mg/day of Topiramate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate/BBCET | Escalating dose of up to 300 mg/day of Topiramate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compliance With Study Requirements: Attendance at Treatment Sessions | Posted | Number | participants | up to 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topiramate/BBCET | Escalating dose of up to 300 mg/day of Topiramate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nassima Ait-Daoud | UVA Center for Addiction Research and Education | 434-243-0541 | uvacare@virginia.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D002032 | Bulimia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Richmond |
| Virginia |
| 23294 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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 | Per protocol | Posted | Mean | Standard Deviation | Drinks/day | up to 24 weeks |
|
|
|
| Primary | 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 | Per protocol | Posted | Mean | Standard Deviation | Mean percent days abstinent per week | up to 24 weeks |
|
|
|
| Primary | 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 | Per protocol | Posted | Mean | Standard Deviation | Binge eating episodes/week | up to 24 weeks |
|
|
|
| Primary | Compliance With Study Requirements: Topiramate Level | Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day | This is the number of participants who reached the dose of 300 mg of topiramate | Posted | Number | participants | up to 12 weeks |
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| 0 |
| 5 |
| 0 |
| 5 |
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| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| Carbohydrates |
| D007661 | Ketoses |