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

Primary Purpose

Binge-Eating Disorder, Obesity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cognitive-Behavioral Therapy (CBT)

NB Medication (on-going from acute treatment)

About this trial

This is an interventional treatment trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive-Behavioral Therapy (CBT)

Naltrexone/bupropion (NB) (on-going from acute stage)

Arm Description

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.

Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.

Outcomes

Primary Outcome Measures

Binge Eating Frequency (Continuous)

Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.

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

Secondary Outcome Measures

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).

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).

Body Mass Index

BMI is calculated using measured height and weight (e.g., percent loss).

Body Mass Index

BMI is calculated using measured height and weight (e.g., percent loss).

Full Information

NCT ID

NCT03063606

First Posted

February 3, 2017

Last Updated

June 14, 2023

Sponsor

Yale University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT03063606

Brief Title

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

Official Title

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 5, 2017 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 .

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binge-Eating Disorder, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive-Behavioral Therapy (CBT)

Arm Type

Experimental

Arm Description

Arm Title

Naltrexone/bupropion (NB) (on-going from acute stage)

Arm Type

Active Comparator

Arm Description

Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive-Behavioral Therapy (CBT)

Intervention Description

CBT specialist treatment

Intervention Type

Drug

Intervention Name(s)

NB Medication (on-going from acute treatment)

Other Intervention Name(s)

Contrave

Intervention Description

Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)

Primary Outcome Measure Information:

Title

Binge Eating Frequency (Continuous)

Description

Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.

Time Frame

Post-treatment (4 months)

Title

Change in Body Mass Index at 4 Months Post-Treatment From Baseline

Description

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

Time Frame

Baseline and Post-treatment (4 months)

Secondary Outcome Measure Information:

Title

Binge Eating Frequency (Continuous)

Description

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

Time Frame

6-Month Follow-up

Title

Binge Eating Frequency (Continuous)

Description

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

Time Frame

12-Month Follow-up

Title

Body Mass Index

Description

BMI is calculated using measured height and weight (e.g., percent loss).

Time Frame

6-Month Follow-up

Title

Body Mass Index

Description

BMI is calculated using measured height and weight (e.g., percent loss).

Time Frame

12-Month Follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos M Grilo, PhD

Organizational Affiliation

Yale School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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