Binge-Eating DisorderPhase 2/3NCT03539900

Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

A Phase 2/3 study testing Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination in people with Binge-Eating Disorder, 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

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Binge-Eating Disorder
What is being tested?: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2018to 22 Mar 2023
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

Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range;
Available for the duration of the treatment and follow-up (15 months);
Read, comprehend, and write English at a sufficient level to complete study-related materials.

Who cannot join

Currently taking opioid pain medications or drugs; or positive drug screen for opiates
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 or 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

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without 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 BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.

Conditions: Binge-Eating Disorder
Being tested: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination, Placebo
Medical subject headings: Binge-Eating Disorder

What participants receive

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

Bupropion Hydrochloride, Naltrexone Hydrochoride Drug CombinationDrug
Also called Contrave
NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
PlaceboOther
Placebo will be inactive and taken daily in pill form.

Study groups in NCT03539900
Study group	Role	What they receive
NB Medication	Experimental	Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination Receives: Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Placebo	Placebo comparator	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.

Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."
Measured: Post-treatment (3 months)
Percent BMI Change
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at posttreatment] - [BMI at baseline])/[BMI at baseline]. Negative values indicate loss.
Measured: Post-treatment (3 months)

Secondary outcomes (4)

Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.
Measured: 6 months post-treatment
Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.
Measured: 12 months post-treatment
Body Mass Index
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 6 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss.
Measured: 6 months post-treatment
Body Mass Index
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 12 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss.
Measured: 12 months post-treatment

Timeline

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

17 Apr 201822 Mar 2023

First posted29 May 2018
Study start17 Apr 2018
Primary completion19 Apr 2022
Study completion22 Mar 2023

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: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03539900
Sponsor's protocol ID: 2000021769
Other IDs: R01DK112771
Status last verified: Mar 2024
First submitted: 16 May 2018
Last updated: 3 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
ClinicalTrials.gov ID: NCT03539900
Acronym / sponsor ID: 2000021769
Conditions: Binge-Eating Disorder
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 17 Apr 2018 (actual)
Primary completion: 19 Apr 2022 (actual)
Study completion: 22 Mar 2023 (actual)
First posted: 29 May 2018 (actual)
Results: Posted 24 Jul 2023

Clinical summary

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

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

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: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug CombinationBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Placebo	Placebo comparator	Other: PlaceboPlacebo 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 (4 listed)

Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range;
Available for the duration of the treatment and follow-up (15 months);
Read, comprehend, and write English at a sufficient level to complete study-related materials.

Key exclusion criteria (7 listed)

Currently taking opioid pain medications or drugs; or positive drug screen for opiates
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 or bulimia nervosa;

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
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug CombinationAlso: ContraveNB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.	Drug	NB Medication
PlaceboPlacebo will be inactive and taken daily in pill form.	Other	Placebo

Primary outcome

Change in Binge Eating Frequency
Time frame: Post-treatment (3 months)
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."
Percent BMI Change
Time frame: Post-treatment (3 months)
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at posttreatment] - [BMI at baseline])/[BMI at baseline]. Negative values indicate loss.

4 secondary outcomes

Change in Binge Eating Frequency
Time frame: 6 months post-treatment
Change in Binge Eating Frequency
Time frame: 12 months post-treatment
Body Mass Index
Time frame: 6 months post-treatment
Body Mass Index
Time frame: 12 months post-treatment

Results and safety

Results posted to the registry on 24 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
NB Medication	43	38
Placebo	46	44

Primary outcome: Change in Binge Eating Frequency

Time frame: Post-treatment (3 months). Mean (Standard Deviation). Unit: binge-eating episodes per month

Measure	NB Medication n = 43	Placebo n = 46
Value	6.4 (10.6)	5.4 (9.6)

NB Medication vs Placebo: p = .44, Mixed Models Analysis

Primary outcome: Percent BMI Change

Time frame: Post-treatment (3 months). Mean (Standard Deviation). Unit: percent BMI change

Measure	NB Medication n = 43	Placebo n = 46
Value	-8.0 (11.3)	-0.5 (8.9)

NB Medication vs Placebo: p = .04, 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 43 (0%)	26 of 43 (60.5%)	0 of 43
Placebo	0 of 46 (0%)	26 of 46 (56.5%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 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
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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
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
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Enrolling by invitation
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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

Sherry McKee, 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 Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination in people with Binge-Eating Disorder, 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 4 inclusion and 7 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 3 Apr 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 24 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?

Change in Binge Eating Frequency (time frame: Post-treatment (3 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 NCT03539900.

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 3 Apr 2024.