Binge Eating Disorder
Conditions
Brief summary
This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.
Interventions
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition) * BMI between 30 kg/m2 and 50 kg/m2 * Not taking anti-depressant medications * Read English proficiently enough to read study assessments * Available for duration of treatment plus follow-up period * Able to travel to study location (New Haven, CT) for monthly visits * Agree to study procedures
Exclusion criteria
* Medical status judged by study physician as contraindication * History of seizures * Past or current anorexia nervosa, bulimia nervosa * Current medications that influence eating/weight * Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Frequency (Continuous) | Post-treatment (at 3 months) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | Post-treatment (at 3 months) | BMI is calculated using measured height and weight. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone/ Bupropion Combination 50 mg naltrexone and 300 mg bupropion per day for 3 months
Naltrexone and bupropion combination | 12 |
| Pill Placebo Daily placebo medication for 3 months
Pill Placebo | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Naltrexone/ Bupropion Combination | Pill Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 10 Participants | 22 Participants |
| Age, Continuous | 51.2 years STANDARD_DEVIATION 8 | 49.4 years STANDARD_DEVIATION 10.1 | 50.4 years STANDARD_DEVIATION 8.8 |
| Binge Eating Frequency | 16.0 binge eating days (out of 28) | 9.2 binge eating days (out of 28) | 12.9 binge eating days (out of 28) |
| Body Mass Index (BMI) | 35.0 kg/m^2 | 40.1 kg/m^2 | 37.3 kg/m^2 |
| Region of Enrollment United States | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 8 |
| other Total, other adverse events | 11 / 11 | 5 / 8 |
| serious Total, serious adverse events | 0 / 11 | 0 / 8 |
Outcome results
Primary
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Time frame: 6 month follow-up (an average of 6 months following treatment)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Naltrexone/ Bupropion Combination | Binge Eating Frequency (Continuous) | 5.4 binge eating days (out of 28) |
| Pill Placebo | Binge Eating Frequency (Continuous) | 2.9 binge eating days (out of 28) |
Primary
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Time frame: Post-treatment (at 3 months)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Naltrexone/ Bupropion Combination | Binge Eating Frequency (Continuous) | 4.4 binge eating days (out of 28) |
| Pill Placebo | Binge Eating Frequency (Continuous) | 3.0 binge eating days (out of 28) |
Secondary
Body Mass Index (BMI)
BMI is calculated using measured height and weight.
Time frame: Post-treatment (at 3 months)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Naltrexone/ Bupropion Combination | Body Mass Index (BMI) | 34.5 kg/m^2 |
| Pill Placebo | Body Mass Index (BMI) | 39.7 kg/m^2 |
Secondary
Body Mass Index (BMI)
BMI is calculated using measured height and weight.
Time frame: 6 month follow-up (an average of 6 months following treatment)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Naltrexone/ Bupropion Combination | Body Mass Index (BMI) | 35.9 kg/m^2 |
| Pill Placebo | Body Mass Index (BMI) | 40.3 kg/m^2 |