Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment

Obesity Clinical Trial

Official title:

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045341
• Other study ID #: 1506016065-A
• Secondary ID: R01DK049587
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 27, 2017
• Est. completion date: December 16, 2022

Study information

• Verified date: March 2023
• 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 behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.

Description:

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity combination medication), alone and in combination, for the treatment of BED in patients with obesity. The acute treatment stage stage RCT will provide new findings regarding the effectiveness of NB medication and whether this specific combination of BWL and NB medication is effective for patients with obesity and BED. N=160 patients with BED and obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study will produce important new information about the relative efficacy of BWL and this recently FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with obesity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 16, 2022
• Est. primary completion date: July 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 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 27-30 with a controlled obesity-related co-morbidity; or BMI = 30 and <50;

• 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;

• Able to travel to study location (New Haven, CT) for weekly 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

Behavioral:
• Behavioral Weight Loss (BWL) counseling
BWL counseling

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	Body Mass Index (Percent Weight Loss)	BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline.	Post-treatment (4 months)
Secondary	Number of Participants Meeting Response Criteria	Binge eating frequency will be assessed by interview and self-report. Frequency is defined categorically (response to treatment or non-response to treatment). Response to treatment is defined as a 65% reduction in binge eating frequency in past month, compared to baseline.	Post-treatment (4 months)