Binge-Eating Disorder, Obesity
Conditions
Brief summary
This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.
Detailed description
Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.
Interventions
NB medication
OTHERPlacebo
Placebo
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participated in acute treatment for binge-eating disorder and obesity; * Had a positive response to acute treatment; * Available for the duration of the treatment and follow-up (20 months); * Read, comprehend, and write English at a sufficient level to complete study-related materials; and * Able to travel to study location (New Haven, CT) for monthly visits.
Exclusion criteria
* Currently taking anti-depressant medications; * Currently taking opioid pain medications or drugs; * Currently taking medications that influence eating/weight; * History of seizures; * Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality); * Past or current anorexia nervosa, bulimia nervosa; * Pregnant or breastfeeding; * Medical status judged by study physician as contraindication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Frequency (Continuous) | Post-treatment (4 months) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). |
| Change in Body Mass Index | baseline and Post-treatment (4 months) | BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Frequency (Continuous) | 6-Month Follow-up | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). |
| Change in Body Mass Index (BMI) | Baseline to 6-Month Follow-up | BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss. |
| Change in Body Mass Index | Baseline to 12-Month Follow-up | BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss. |
Countries
United States
Participant flow
Pre-assignment details
The main study (acute treatment results) can be found in NCT03045341. Two participants dropped prior to beginning the medication.
Participants by arm
| Arm | Count |
|---|---|
| NB Medication Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
NB medication (Naltrexone Bupropion combination): NB medication | 32 |
| Placebo Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
Placebo: Placebo | 34 |
| Total | 66 |
Baseline characteristics
| Characteristic | NB Medication | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 50.40 years STANDARD_DEVIATION 11.7 | 46.92 years STANDARD_DEVIATION 12.15 | 43.60 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 57 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 47 Participants | 22 Participants |
| Sex/Gender, Customized Men | 3 Participants | 9 Participants | 6 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Women | 28 Participants | 56 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 34 |
| other Total, other adverse events | 21 / 32 | 18 / 34 |
| serious Total, serious adverse events | 0 / 32 | 0 / 34 |
Outcome results
Primary
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time frame: Post-treatment (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Binge Eating Frequency (Continuous) | 0.86 binge eating days per month | Standard Deviation 2.15 |
| Placebo | Binge Eating Frequency (Continuous) | 3.25 binge eating days per month | Standard Deviation 7.06 |
p-value: 0.07Mixed Models Analysis
Primary
Change in Body Mass Index
BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.
Time frame: baseline and Post-treatment (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Change in Body Mass Index | -0.03 percentage weight change | Standard Deviation 0.05 |
| Placebo | Change in Body Mass Index | .01 percentage weight change | Standard Deviation 0.04 |
p-value: 0.01Mixed Models Analysis
Secondary
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time frame: 6-Month Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Binge Eating Frequency (Continuous) | 1.57 eating events/28 days | Standard Deviation 4.42 |
| Placebo | Binge Eating Frequency (Continuous) | 2.43 eating events/28 days | Standard Deviation 4.92 |
Secondary
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time frame: 12-Month Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Binge Eating Frequency (Continuous) | 3.35 eating events/28 days | Standard Deviation 6.58 |
| Placebo | Binge Eating Frequency (Continuous) | 2.77 eating events/28 days | Standard Deviation 6.15 |
Secondary
Change in Body Mass Index
BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.
Time frame: Baseline to 12-Month Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Change in Body Mass Index | .025 percentage change in BMI | Standard Deviation 0.079 |
| Placebo | Change in Body Mass Index | .042 percentage change in BMI | Standard Deviation 0.076 |
Secondary
Change in Body Mass Index (BMI)
BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.
Time frame: Baseline to 6-Month Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Change in Body Mass Index (BMI) | .004 percentage change in BMI | Standard Deviation 0.065 |
| Placebo | Change in Body Mass Index (BMI) | .026 percentage change in BMI | Standard Deviation 0.063 |