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

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

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 .

Study Overview

• Status: Completed
• Conditions: Obesity; Binge-Eating Disorder
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy (CBT); Drug: NB Medication (on-going from acute treatment)

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-Behavioral Therapy (CBT); CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.	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); Other Names: Contrave
Active Comparator: Naltrexone/bupropion (NB) (on-going from acute stage); Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.	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); Other Names: Contrave

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	BMI is calculated using measured height and weight (e.g., percent loss).	6-Month Follow-up
Body Mass Index	BMI is calculated using measured height and weight (e.g., percent loss).	12-Month Follow-up

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Carlos M Grilo, PhD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperphagia; Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Anti-Obesity Agents; Bupropion hydrochloride, naltrexone hydrochoride drug combination
• Other Study ID Numbers: 1506016065-S; R01DK049587 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No