Binge-Eating DisorderPhase 2/3NCT03063606

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

A Phase 2/3 study testing Cognitive-Behavioral Therapy (CBT) and NB Medication (on-going from acute treatment) in people with Binge-Eating Disorder and Obesity, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Binge-Eating Disorder, Obesity
What is being tested?: Cognitive-Behavioral Therapy (CBT) and NB Medication (on-going from acute treatment)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 5 Sep 2017to 16 Dec 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale School of Medicine
New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Read the 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).

Conditions: Binge-Eating Disorder, Obesity
Being tested: Cognitive-Behavioral Therapy (CBT), NB Medication (on-going from acute treatment)
Medical subject headings: Binge-Eating Disorder, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive-Behavioral Therapy (CBT)Behavioural
CBT specialist treatment
NB Medication (on-going from acute treatment)Drug
Also called Contrave
Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)

Study groups in NCT03063606
Study group	Role	What they receive
Cognitive-Behavioral Therapy (CBT)	Experimental	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. Receives: Behavioral: Cognitive-Behavioral Therapy (CBT); Drug: NB Medication (on-going from acute treatment)
Naltrexone/bupropion (NB) (on-going from acute stage)	Active comparator	Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. Receives: Drug: NB Medication (on-going from acute treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

Binge Eating Frequency (Continuous)
Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.
Measured: 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
Measured: Baseline and Post-treatment (4 months)

Secondary outcomes (2)

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).
Measured: 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).
Measured: 12-Month Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201716 Dec 2022

First posted24 Feb 2017
Study start5 Sep 2017
Primary completion1 Dec 2021
Study completion16 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03063606
Sponsor's protocol ID: 1506016065-S
Other IDs: R01DK049587
Status last verified: Jan 2024
First submitted: 3 Feb 2017
Last updated: 1 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder

All Binge-Eating Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
ClinicalTrials.gov ID: NCT03063606
Acronym / sponsor ID: 1506016065-S
Conditions: Binge-Eating Disorder, Obesity
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 5 Sep 2017 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 16 Dec 2022 (actual)
First posted: 24 Feb 2017 (actual)
Results: Posted 7 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cognitive-Behavioral Therapy (CBT)	Experimental	Behavioral: Cognitive-Behavioral Therapy (CBT), Drug: NB Medication (on-going from acute treatment)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.
Naltrexone/bupropion (NB) (on-going from acute stage)	Active comparator	Drug: NB Medication (on-going from acute treatment)Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive-Behavioral Therapy (CBT)CBT specialist treatment	Behavioural	Cognitive-Behavioral Therapy (CBT)
NB Medication (on-going from acute treatment)Also: ContraveNaltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)	Drug	Cognitive-Behavioral Therapy (CBT), Naltrexone/bupropion (NB) (on-going from acute stage)

Primary outcome

Binge Eating Frequency (Continuous)
Time frame: Post-treatment (4 months)
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
Time frame: Baseline and Post-treatment (4 months)
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

2 secondary outcomes

Binge Eating Frequency (Continuous)
Time frame: 6-Month Follow-up
Binge Eating Frequency (Continuous)
Time frame: 12-Month Follow-up

Results and safety

Results posted to the registry on 7 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy	18	16
On-going Blinded Pharmacotherapy	13	10

Primary outcome: Binge Eating Frequency (Continuous)

Time frame: Post-treatment (4 months). Mean (Standard Deviation). Unit: Eating events/28 days

Measure	Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy n = 15	On-going Blinded Pharmacotherapy n = 10
Value	0.8 (1.6)	12.1 (9.9)

Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy vs On-going Blinded Pharmacotherapy: p = .0002, Mixed Models Analysis

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

Time frame: Baseline and Post-treatment (4 months). Mean (Standard Deviation). Unit: Kg/m^2

Measure	Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy n = 11	On-going Blinded Pharmacotherapy n = 10
Value	-0.16 (4.27)	-1.18 (4.35)

Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy vs On-going Blinded Pharmacotherapy: p = .83, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Month 1. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
On-going Blinded Pharmacotherapy (NB)	0 of 15 (0%)	3 of 15 (20%)	0 of 15
On-going Blinded Pharmacotherapy (Placebo)	0 of 16 (0%)	5 of 16 (31.3%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Binge-Eating Disorder

Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carlos M Grilo, PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binge Eating Frequency (Continuous) (time frame: Post-treatment (4 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03063606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.