A Phase 2/3 interventional study of NB medication (Naltrexone Bupropion combination) and Placebo in Binge-Eating Disorder and Obesity, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by Yale University · Phase 2/3, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 68 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Exclusion Criteria:
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.
Drug: NB medication (Naltrexone Bupropion combination)
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
Other: Placebo
NB medication
Also known as: Contrave
Placebo
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)
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)
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
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
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
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
| Milestone | NB Medication | Placebo |
|---|---|---|
| Started | 32 | 34 |
| Completed | 29 | 28 |
| Not completed | 3 | 6 |
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
| binge eating days per month | NB Medication | Placebo |
|---|---|---|
| Binge Eating Frequency (Continuous) | 0.86 ± 2.15 | 3.25 ± 7.06 |
BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.
| percentage weight change | NB Medication | Placebo |
|---|---|---|
| Change in Body Mass Index | -0.03 ± .05 | .01 ± .04 |
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
| eating events/28 days | NB Medication | Placebo |
|---|---|---|
| Binge Eating Frequency (Continuous) | 1.57 ± 4.42 | 2.43 ± 4.92 |
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
| eating events/28 days | NB Medication | Placebo |
|---|---|---|
| Binge Eating Frequency (Continuous) | 3.35 ± 6.58 | 2.77 ± 6.15 |
BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.
| percentage change in BMI | NB Medication | Placebo |
|---|---|---|
| Change in Body Mass Index (BMI) | .004 ± .065 | .026 ± .063 |
BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.
| percentage change in BMI | NB Medication | Placebo |
|---|---|---|
| Change in Body Mass Index | .025 ± .079 | .042 ± .076 |
Collected over Month 1. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NB Medication | 0/32 (0%) | 0/32 (0%) | 21/32 (65.6%) |
| Placebo | 0/34 (0%) | 0/34 (0%) | 18/34 (52.9%) |
| Event | NB Medication | Placebo |
|---|---|---|
| Hypertensive CrisisCardiac disorders | 0/32 | 0/34 |
| Event | NB Medication | Placebo |
|---|---|---|
| ConstipationGastrointestinal disorders | 10/32 | 5/34 |
| Dry MouthGeneral disorders | 10/32 | 3/34 |
| HeadacheGeneral disorders | 9/32 | 4/34 |
| InsomniaGeneral disorders | 7/32 | 9/34 |
| NauseaGastrointestinal disorders | 8/32 | 3/34 |
| AnxietyPsychiatric disorders | 2/32 | 6/34 |
| DiarrheaGastrointestinal disorders | 2/32 | 5/34 |
| DizzinessGeneral disorders | 4/32 | 4/34 |
| VomitingGastrointestinal disorders | 3/32 | 3/34 |
| Age, Continuous(years) | NB Medication | Placebo | Total |
|---|---|---|---|
| Mean | 50.40 ± 11.70 | 43.60 ± 11.80 | 46.92 ± 12.15 |
| Sex/Gender, Customized(Participants) | NB Medication | Placebo | Total |
|---|---|---|---|
| Men | 3 | 6 | 9 |
| Women | 28 | 28 | 56 |
| Other | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | NB Medication | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 6 | 9 |
| Not Hispanic or Latino | 29 | 28 | 57 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NB Medication | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 25 | 22 | 47 |
| More than one race | 1 | 4 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
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