N/A N=22 Randomized Triple-blind Treatment

Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

Binge Eating Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02317744 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Binge Eating Frequency (Continuous) — 4.4; 3.0 binge eating days (out of 28)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Naltrexone and bupropion combination (Drug); Pill Placebo (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Binge Eating Frequency (Continuous)	5.4; 2.9	—
PRIMARY Binge Eating Frequency (Continuous)	5.4; 2.9	—
SECONDARY Body Mass Index (BMI)	35.9; 40.3	—
SECONDARY Body Mass Index (BMI)	35.9; 40.3	—

Summary

This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.

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 between 30 kg/m2 and 50 kg/m2
Not taking anti-depressant medications
Read English proficiently enough to read study assessments
Available for duration of treatment plus follow-up period
Able to travel to study location (New Haven, CT) for monthly visits
Agree to study procedures

Exclusion Criteria

Medical status judged by study physician as contraindication
History of seizures
Past or current anorexia nervosa, bulimia nervosa
Current medications that influence eating/weight
Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
Pregnant or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02317744). 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.