Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

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.

• NB medication (Naltrexone Bupropion combination) (Drug), also known as Contrave: NB medication
• Placebo (Other): Placebo

Primary outcomes

• 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 outcomes

• 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).
• Binge Eating Frequency (Continuous) [12-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.

Sex: All, ages: 18 Years to 70 Years

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.

Participant flow

Outcome results

• Binge Eating Frequency (Continuous) (Primary), Mean, binge eating days per month: NB Medication 0.86 +/- 2.15; Placebo 3.25 +/- 7.06 (p .07)
• Change in Body Mass Index (Primary), Mean, percentage weight change: NB Medication -0.03 +/- .05; Placebo .01 +/- .04 (p .01)
• Binge Eating Frequency (Continuous) (Secondary), Mean, eating events/28 days: NB Medication 1.57 +/- 4.42; Placebo 2.43 +/- 4.92
• Binge Eating Frequency (Continuous) (Secondary), Mean, eating events/28 days: NB Medication 3.35 +/- 6.58; Placebo 2.77 +/- 6.15
• Change in Body Mass Index (BMI) (Secondary), Mean, percentage change in BMI: NB Medication .004 +/- .065; Placebo .026 +/- .063
• Change in Body Mass Index (Secondary), Mean, percentage change in BMI: NB Medication .025 +/- .079; Placebo .042 +/- .076

Adverse events

Time frame: Month 1

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2020-10-28)

• Carlos M Grilo, PhD, Principal investigator, Yale University

NIH grants: R01DK049587