Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

March 11, 2024 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NB Medication
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
Other Names:
  • Contrave
Placebo Comparator: Placebo
Placebo will be inactive and taken daily in pill form.
Other: Placebo
Placebo will be inactive and taken daily in pill form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Binge Eating Frequency
Time Frame: Post-treatment (3 months)
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."
Post-treatment (3 months)
Percent BMI Change
Time Frame: Post-treatment (3 months)
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at posttreatment] - [BMI at baseline])/[BMI at baseline]. Negative values indicate loss.
Post-treatment (3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Binge Eating Frequency
Time Frame: 6 months post-treatment
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.
6 months post-treatment
Change in Binge Eating Frequency
Time Frame: 12 months post-treatment
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.
12 months post-treatment
Body Mass Index
Time Frame: 6 months post-treatment
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 6 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss.
6 months post-treatment
Body Mass Index
Time Frame: 12 months post-treatment
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 12 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss.
12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Carlos M Grilo, PhD, Yale School of Medicine
  • Principal Investigator: Sherry McKee, PhD, Yale School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2018

Primary Completion (Actual)

April 19, 2022

Study Completion (Actual)

March 22, 2023

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000021769
  • R01DK112771 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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