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

November 21, 2017 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 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

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: Naltrexone/ Bupropion combination
50 mg naltrexone and 300 mg bupropion per day for 3 months
Drug: Naltrexone and bupropion combination
Placebo Comparator: Pill placebo
Daily placebo medication for 3 months
Other: Pill Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binge Eating Frequency (Continuous)
Time Frame: Post-treatment (at 3 months)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Post-treatment (at 3 months)
Binge Eating Frequency (Continuous)
Time Frame: 6 month follow-up (an average of 6 months following treatment)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
6 month follow-up (an average of 6 months following treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Post-treatment (at 3 months)
BMI is calculated using measured height and weight.
Post-treatment (at 3 months)
Body Mass Index (BMI)
Time Frame: 6 month follow-up (an average of 6 months following treatment)
BMI is calculated using measured height and weight.
6 month follow-up (an average of 6 months following treatment)

Collaborators and Investigators

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

Sponsor

Yale University

Investigators

  • Principal Investigator: Carlos M Grilo, Ph.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 16, 2014

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1409014705

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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