Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

  • STATUS
    Recruiting
  • End date
    Jun 22, 2025
  • participants needed
    200
  • sponsor
    Yale University
Updated on 22 July 2021
psychiatric disorder
naltrexone
bupropion
bulimia

Summary

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

Description

Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.

Details
Condition Binge eating, Binge Eating Disorder, binges
Treatment Placebo, Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Clinical Study IdentifierNCT03539900
SponsorYale University
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range
Available for the duration of the treatment and follow-up (15 months)
Read, comprehend, and write English at a sufficient level to complete study-related materials

Exclusion Criteria

Currently taking opioid pain medications or drugs; or positive drug screen for opiates
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 or bulimia nervosa
Pregnant or breastfeeding
Medical status judged by study physician as contraindication
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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