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

Primary Purpose

Binge Eating Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Naltrexone and bupropion combination

Pill Placebo

About this trial

This is an interventional treatment trial for Binge Eating Disorder

Eligibility Criteria

21 Years - 65 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 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

Sites / Locations

Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naltrexone/ Bupropion combination

Pill placebo

Arm Description

50 mg naltrexone and 300 mg bupropion per day for 3 months

Daily placebo medication for 3 months

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 also is 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 also is defined continuously (analyzed dimensionally).

Secondary Outcome Measures

Body Mass Index (BMI)

BMI is calculated using measured height and weight.

Body Mass Index (BMI)

BMI is calculated using measured height and weight.

Full Information

NCT ID

NCT02317744

First Posted

December 11, 2014

Last Updated

November 21, 2017

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02317744

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

5. Study Description

Brief 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.

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

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naltrexone/ Bupropion combination

Arm Type

Experimental

Arm Description

50 mg naltrexone and 300 mg bupropion per day for 3 months

Arm Title

Pill placebo

Arm Type

Placebo Comparator

Arm Description

Daily placebo medication for 3 months

Intervention Type

Drug

Intervention Name(s)

Naltrexone and bupropion combination

Intervention Type

Other

Intervention Name(s)

Pill 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 also is defined continuously (analyzed dimensionally).

Time Frame

Post-treatment (at 3 months)

Title

Binge Eating Frequency (Continuous)

Description

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).

Time Frame

6 month follow-up (an average of 6 months following treatment)

Secondary Outcome Measure Information:

Title

Body Mass Index (BMI)

Description

BMI is calculated using measured height and weight.

Time Frame

Post-treatment (at 3 months)

Title

Body Mass Index (BMI)

Description

BMI is calculated using measured height and weight.

Time Frame

6 month follow-up (an average of 6 months following treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos M Grilo, Ph.D.

Organizational Affiliation

Yale University

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

Citations:

PubMed Identifier

33218742

Citation

Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clin Ther. 2021 Jan;43(1):112-122.e1. doi: 10.1016/j.clinthera.2020.10.010. Epub 2020 Nov 18.

Results Reference

derived

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

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