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Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

Primary Purpose

Binge-Eating Disorder, Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NB medication (Naltrexone Bupropion 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:

  • Participated in acute treatment for binge-eating disorder and obesity;
  • Had a positive response to acute treatment;
  • 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; and
  • Able to travel to study location (New Haven, CT) for monthly 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.

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

Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.

Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

Outcomes

Primary Outcome Measures

Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Change in Body Mass Index
BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.

Secondary Outcome Measures

Binge Eating Frequency (Continuous)
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 (Continuous)
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 is calculated using measured height and weight (e.g., percent loss)
Body Mass Index
BMI is calculated using measured height and weight (e.g., percent loss)

Full Information

First Posted
February 5, 2017
Last Updated
April 14, 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
NCT03047005
Brief Title
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Official Title
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 16, 2022 (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
No

5. Study Description

Brief Summary
This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.
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 obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
NB medication
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
Intervention Type
Drug
Intervention Name(s)
NB medication (Naltrexone Bupropion combination)
Other Intervention Name(s)
Contrave
Intervention Description
NB medication
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Binge Eating Frequency (Continuous)
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
Post-treatment (4 months)
Title
Change in Body Mass Index
Description
BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.
Time Frame
baseline and Post-treatment (4 months)
Secondary Outcome Measure Information:
Title
Binge Eating Frequency (Continuous)
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-Month Follow-up
Title
Binge Eating Frequency (Continuous)
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-Month Follow-up
Title
Body Mass Index
Description
BMI is calculated using measured height and weight (e.g., percent loss)
Time Frame
6-Month Follow-up
Title
Body Mass Index
Description
BMI is calculated using measured height and weight (e.g., percent loss)
Time Frame
12-Month Follow-up

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: Participated in acute treatment for binge-eating disorder and obesity; Had a positive response to acute treatment; 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; and Able to travel to study location (New Haven, CT) for monthly 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.
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
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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Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

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