Binge-Eating DisorderPhase 2/3NCT03047005

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

A Phase 2/3 study testing NB medication (Naltrexone Bupropion combination) 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

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Binge-Eating Disorder, Obesity
What is being tested?: NB medication (Naltrexone Bupropion combination)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited States
Study dates: 28 Aug 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;
Had 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 monthly 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

This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

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 (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

Conditions: Binge-Eating Disorder, Obesity
Being tested: NB medication (Naltrexone Bupropion combination), Placebo
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.

NB medication (Naltrexone Bupropion combination)Drug
Also called Contrave
NB medication
PlaceboOther
Placebo

Study groups in NCT03047005
Study group	Role	What they receive
NB medication	Experimental	Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. Receives: Drug: NB medication (Naltrexone Bupropion combination)
Placebo	Placebo comparator	Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Receives: Other: Placebo

What is being measured

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

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: Post-treatment (4 months)
Change in Body Mass Index
BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.
Measured: baseline and Post-treatment (4 months)

Secondary outcomes (4)

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
Change in Body Mass Index (BMI)
BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.
Measured: Baseline to 6-Month Follow-up
Change in Body Mass Index
BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.
Measured: Baseline to 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.

28 Aug 201716 Dec 2022

First posted8 Feb 2017 (estimated)
Study start28 Aug 2017
Primary completion16 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03047005
Sponsor's protocol ID: 1506016065-M
Other IDs: R01DK049587
Status last verified: Feb 2024
First submitted: 5 Feb 2017
Last updated: 2 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

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All Binge-Eating Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 2 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: NCT03047005
Acronym / sponsor ID: 1506016065-M
Conditions: Binge-Eating Disorder, Obesity
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 28 Aug 2017 (actual)
Primary completion: 16 Dec 2021 (actual)
Study completion: 16 Dec 2022 (actual)
First posted: 8 Feb 2017 (estimated)
Results: Posted 6 May 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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NB medication	Experimental	Drug: NB medication (Naltrexone Bupropion combination)Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
Placebo	Placebo comparator	Other: PlaceboParticipants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

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;
Had 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 monthly 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
NB medication (Naltrexone Bupropion combination)Also: ContraveNB medication	Drug	NB medication
PlaceboPlacebo	Other	Placebo

Primary outcome

Binge Eating Frequency (Continuous)
Time frame: Post-treatment (4 months)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Change in Body Mass Index
Time frame: baseline and Post-treatment (4 months)
BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.

4 secondary outcomes

Binge Eating Frequency (Continuous)
Time frame: 6-Month Follow-up
Binge Eating Frequency (Continuous)
Time frame: 12-Month Follow-up
Change in Body Mass Index (BMI)
Time frame: Baseline to 6-Month Follow-up
Change in Body Mass Index
Time frame: Baseline to 12-Month Follow-up

Results and safety

Results posted to the registry on 6 May 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
NB Medication	32	29
Placebo	34	28

Primary outcome: Binge Eating Frequency (Continuous)

Time frame: Post-treatment (4 months). Mean (Standard Deviation). Unit: binge eating days per month

Measure	NB Medication n = 29	Placebo n = 28
Value	0.86 (2.15)	3.25 (7.06)

NB Medication vs Placebo: p = .07, Mixed Models Analysis

Primary outcome: Change in Body Mass Index

Time frame: baseline and Post-treatment (4 months). Mean (Standard Deviation). Unit: percentage weight change

Measure	NB Medication n = 29	Placebo n = 26
Value	-0.03 (.05)	.01 (.04)

NB Medication vs Placebo: p = .01, Mixed Models Analysis

4 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
NB Medication	0 of 32 (0%)	21 of 32 (65.6%)	0 of 32
Placebo	0 of 34 (0%)	18 of 34 (52.9%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Binge-Eating Disorder

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Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
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Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
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Not yet recruiting
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Enrolling by invitation
Sleep and Activity For Eating Disorders
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Project VIBE: Virtual Intervention for Binge Eating in Adolescents
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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?

A Phase 2/3 study testing NB medication (Naltrexone Bupropion combination) in people with Binge-Eating Disorder and Obesity, run by Yale University at 1 site in United States.

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 2 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. Some participants in this study may receive a placebo. 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 6 May 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 NCT03047005.

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 2 Feb 2024.