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

Obesity Clinical Trial

Official title:

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063606
• Other study ID #: 1506016065-S
• Secondary ID: R01DK049587
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 5, 2017
• Est. completion date: December 16, 2022

Study information

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

Clinical Trial Summary

This study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .

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 (specialist treatment) RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 16, 2022
• Est. primary completion date: December 1, 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;

• Did not have 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 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

Behavioral:
• Cognitive-Behavioral Therapy (CBT)
CBT specialist treatment

Drug:
• NB Medication (on-going from acute treatment)
Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or 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
Other	Body Mass Index	BMI is calculated using measured height and weight (e.g., percent loss).	12-Month Follow-up
Other	Body Mass Index	BMI is calculated using measured height and weight (e.g., percent loss).	6-Month Follow-up
Primary	Binge Eating Frequency (Continuous)	Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.	Post-treatment (4 months)
Primary	Change in Body Mass Index at 4 Months Post-Treatment From Baseline	BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline	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