Phase 3 N=136 Randomized Double-blind Treatment

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment

Binge-eating Disorder · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT03045341 ↗

Enrolled (actual)

136

Serious AEs

0.9%

Results posted

Dec 2022

Primary outcome: Primary: Binge Eating Frequency (Continuous) — 9.90; 7.63; 3.30; 1.97 binge-eating episodes per month — p=0.0001

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Binge Eating Frequency (Continuous)	9.90; 7.63; 3.30; 1.97	0.0001 sig
PRIMARY Body Mass Index (Percent Weight Loss)	1.05; -2.11; -4.42; -5.71	0.0001 sig
SECONDARY Number of Participants Meeting Response Criteria	14; 14; 20; 25	.004 sig

Summary

This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.

Eligibility Criteria

Inclusion Criteria

Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;
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;
Able to travel to study location (New Haven, CT) for weekly 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 (NCT03045341). 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.