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Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Primary Purpose

Binge-Eating Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NB Medication

Placebo

Arm Description

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination

Placebo will be inactive and taken daily in pill form.

Outcomes

Primary Outcome Measures

Change in Binge Eating Frequency
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."
Percent BMI Change
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.

Secondary Outcome Measures

Binge Eating Frequency
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Binge Eating Frequency
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Body Mass Index
BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.
Body Mass Index
BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.

Full Information

First Posted
May 16, 2018
Last Updated
October 19, 2023
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03539900
Brief Title
Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Official Title
Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
March 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NB Medication
Arm Type
Experimental
Arm Description
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be inactive and taken daily in pill form.
Intervention Type
Drug
Intervention Name(s)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Other Intervention Name(s)
Contrave
Intervention Description
NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be inactive and taken daily in pill form.
Primary Outcome Measure Information:
Title
Change in Binge Eating Frequency
Description
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."
Time Frame
Post-treatment (3 months)
Title
Percent BMI Change
Description
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.
Time Frame
Post-treatment (3 months)
Secondary Outcome Measure Information:
Title
Binge Eating Frequency
Description
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time Frame
12 months post-treatment
Title
Binge Eating Frequency
Description
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time Frame
6 months post-treatment
Title
Body Mass Index
Description
BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.
Time Frame
6 months post-treatment
Title
Body Mass Index
Description
BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.
Time Frame
12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos M Grilo, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherry McKee, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

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Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

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