Alcohol Dependence, Binge Eating
Conditions
Keywords
drinking, eating, obesity, alcohol, binge eating
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.
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.
Interventions
DRUGTopiramate
Topiramate up to 300 mg per day.
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Study Requirements: Attendance at Treatment Sessions | up to 12 weeks | — |
| Mean Drinks Per Day at Baseline vs. Visit 12 | 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 |
| Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12 | 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 |
| Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12 | 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 |
| Compliance With Study Requirements: Topiramate Level | up to 12 weeks | Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in Charlottesville and Richmond between September 2006 to February 2007.
Participants by arm
| Arm | Count |
|---|---|
| Topiramate/BBCET Escalating dose of up to 300 mg/day of Topiramate | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Topiramate/BBCET |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 10.46422 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Compliance With Study Requirements: Attendance at Treatment Sessions
Time frame: up to 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topiramate/BBCET | Compliance With Study Requirements: Attendance at Treatment Sessions | Number of subjects completed through Visit 4 | 5 participants |
| Topiramate/BBCET | Compliance With Study Requirements: Attendance at Treatment Sessions | Number of subjects completed through Visit 12 | 3 participants |
Primary
Compliance With Study Requirements: Topiramate Level
Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day
Time frame: up to 12 weeks
Population: This is the number of participants who reached the dose of 300 mg of topiramate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topiramate/BBCET | Compliance With Study Requirements: Topiramate Level | 5 participants |
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
Time frame: up to 24 weeks
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Topiramate/BBCET | Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12 | Mean weekly binge eating episodes at baseline | 3.7 Binge eating episodes/week | Standard Deviation 2.11 |
| Topiramate/BBCET | Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12 | Mean weekly binge eating episodes at Visit 12 | 1 Binge eating episodes/week | Standard Deviation 1.7 |
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
Time frame: up to 24 weeks
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Topiramate/BBCET | Mean Drinks Per Day at Baseline vs. Visit 12 | Mean drinks per day at baseline | 10.95 Drinks/day | Standard Deviation 13.85 |
| Topiramate/BBCET | Mean Drinks Per Day at Baseline vs. Visit 12 | Mean drinks per day at Visit 12 | 0.68 Drinks/day | Standard Deviation 1.13 |
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
Time frame: up to 24 weeks
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Topiramate/BBCET | Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12 | Mean percent days abstinent per week at baseline | 20 Mean percent days abstinent per week | Standard Deviation 21.67 |
| Topiramate/BBCET | Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12 | Mean percent days abstinent per week at Visit 12 | 76.2 Mean percent days abstinent per week | Standard Deviation 7.14 |