Phase 3 N=66 Randomized Triple-blind Treatment

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

Binge-Eating Disorder · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT03047005 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Binge Eating Frequency (Continuous) — 0.86; 3.25 binge eating days per month — p=.07

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: NB medication (Naltrexone Bupropion combination) (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Binge Eating Frequency (Continuous)	3.35; 2.77	—
PRIMARY Change in Body Mass Index	.025; .042	—
SECONDARY Binge Eating Frequency (Continuous)	3.35; 2.77	—
SECONDARY Binge Eating Frequency (Continuous)	3.35; 2.77	—
SECONDARY Change in Body Mass Index (BMI)	.004; .026	—
SECONDARY Change in Body Mass Index	.025; .042	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03047005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.