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

Binge Eating Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317744
• Other study ID #: 1409014705
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: November 21, 2017
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: November 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders

Intervention

Drug:
• Naltrexone and bupropion combination

Other:
• Pill Placebo

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Post-treatment (at 3 months)
Primary	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).	6 month follow-up (an average of 6 months following treatment)
Secondary	Body Mass Index (BMI)	BMI is calculated using measured height and weight.	Post-treatment (at 3 months)
Secondary	Body Mass Index (BMI)	BMI is calculated using measured height and weight.	6 month follow-up (an average of 6 months following treatment)