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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
First received
Last updated
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
Health authority
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.

Study Design


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
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