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

Obesity Clinical Trial

Official title:

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047005
• Other study ID #: 1506016065-M
• Secondary ID: R01DK049587
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 28, 2017
• Est. completion date: December 16, 2022

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• NB medication (Naltrexone Bupropion combination)
NB medication

Other:
• Placebo
Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 will be defined continuously (analyzed dimensionally).	Post-treatment (4 months)
Primary	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.	baseline and Post-treatment (4 months)
Secondary	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).	6-Month Follow-up
Secondary	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).	12-Month Follow-up
Secondary	Change in Body Mass Index (BMI)	BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.	Baseline to 6-Month Follow-up
Secondary	Change in Body Mass Index	BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.	Baseline to 12-Month Follow-up