Binge-eating DisorderPhase 2/3NCT03045341

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

A Phase 2/3 study testing NB medication (Naltrexone Bupropion combination) and Behavioral Weight Loss (BWL) counseling 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

This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. 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?: NB medication (Naltrexone Bupropion combination) and Behavioral Weight Loss (BWL) counseling
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 136 participants
Where: 1 siteUnited States
Study dates: 27 Feb 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

Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;
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;
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 obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity combination medication), alone and in combination, for the treatment of BED in patients with obesity. The acute treatment stage stage RCT will provide new findings regarding the effectiveness of NB medication and whether this specific combination of BWL and NB medication is effective for patients with obesity and BED. N=160 patients with BED and obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study will produce important new information about the relative efficacy of BWL and this recently FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with obesity.

Conditions: Binge-eating Disorder, Obesity
Being tested: NB medication (Naltrexone Bupropion combination), Behavioral Weight Loss (BWL) counseling, 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
Behavioral Weight Loss (BWL) counselingBehavioural
BWL counseling
PlaceboOther
Placebo

Study groups in NCT03045341
Study group	Role	What they receive
BWL + NB medication	Experimental	Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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); Behavioral: Behavioral Weight Loss (BWL) counseling
BWL + Placebo	Experimental	Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form. Receives: Behavioral: Behavioral Weight Loss (BWL) counseling; Other: Placebo
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)
Body Mass Index (Percent Weight Loss)
BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline.
Measured: Post-treatment (4 months)

Secondary outcomes (1)

Number of Participants Meeting Response Criteria
Binge eating frequency will be assessed by interview and self-report. Frequency is defined categorically (response to treatment or non-response to treatment). Response to treatment is defined as a 65% reduction in binge eating frequency in past month, compared to baseline.
Measured: Post-treatment (4 months)

Timeline

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

27 Feb 201716 Dec 2022

First posted7 Feb 2017 (estimated)
Study start27 Feb 2017
Primary completion23 Jul 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.
Publications (1)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03045341
Sponsor's protocol ID: 1506016065-A
Other IDs: R01DK049587
Status last verified: Mar 2023
First submitted: 3 Feb 2017
Last updated: 8 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Grilo CM, Lydecker JA, Fineberg SK, Moreno JO, Ivezaj V, Gueorguieva R. Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2022 Dec 1;179(12):927-937. doi: 10.1176/appi.ajp.20220267. Epub 2022 Oct 26.
PubMed 36285406

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 8 Mar 2023. 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: NCT03045341
Acronym / sponsor ID: 1506016065-A
Conditions: Binge-eating Disorder, Obesity
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 27 Feb 2017 (actual)
Primary completion: 23 Jul 2021 (actual)
Study completion: 16 Dec 2022 (actual)
First posted: 7 Feb 2017 (estimated)
Results: Posted 20 Dec 2022

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: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BWL + NB medication	Experimental	Drug: NB medication (Naltrexone Bupropion combination), Behavioral: Behavioral Weight Loss (BWL) counselingParticipants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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.
BWL + Placebo	Experimental	Behavioral: Behavioral Weight Loss (BWL) counseling, Other: PlaceboParticipants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
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)

Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;
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;
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
NB medication (Naltrexone Bupropion combination)Also: ContraveNB medication	Drug	BWL + NB medication, NB medication
Behavioral Weight Loss (BWL) counselingBWL counseling	Behavioural	BWL + NB medication, BWL + Placebo
PlaceboPlacebo	Other	BWL + Placebo, 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).
Body Mass Index (Percent Weight Loss)
Time frame: Post-treatment (4 months)
BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline.

1 secondary outcome

Number of Participants Meeting Response Criteria
Time frame: Post-treatment (4 months)

Results and safety

Results posted to the registry on 20 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	34	29
NB Medication	32	27
BWL + Placebo	35	27
BWL + NB Medication	35	29

Primary outcome: Binge Eating Frequency (Continuous)

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

Measure	Placebo n = 29	NB Medication n = 27	BWL + Placebo n = 27	BWL + NB Medication n = 29
Value	9.90 (20.31)	7.63 (9.77)	3.30 (5.28)	1.97 (4.87)

Placebo vs NB Medication vs BWL + Placebo vs BWL + NB Medication: p = 0.0001, Mixed Models Analysis
Placebo vs NB Medication vs BWL + Placebo vs BWL + NB Medication: p = 0.58, Mixed Models Analysis

Primary outcome: Body Mass Index (Percent Weight Loss)

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

Measure	Placebo n = 29	NB Medication n = 26	BWL + Placebo n = 26	BWL + NB Medication n = 29
Value	1.05 (4.26)	-2.11 (5.41)	-4.42 (5.70)	-5.71 (5.85)

Placebo vs NB Medication vs BWL + Placebo vs BWL + NB Medication: p = 0.0001, Mixed Models Analysis
Placebo vs NB Medication vs BWL + Placebo vs BWL + NB Medication: p = 0.63, Mixed Models Analysis

Population analysed: Analyses used all available data.

1 secondary outcome is 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
Placebo	0 of 31 (0%)	18 of 31 (58.1%)	0 of 31
NB Medication	0 of 27 (0%)	24 of 27 (88.9%)	0 of 27
BWL + Placebo	1 of 29 (3.4%)	20 of 29 (69%)	0 of 29
BWL + NB Medication	0 of 31 (0%)	24 of 31 (77.4%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36285406Grilo CM, Lydecker JA, Fineberg SK, Moreno JO, Ivezaj V, Gueorguieva R. Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2022 Dec 1;179(12):927-937. doi: 10.1176/appi.ajp.20220267. Epub 2022 Oct 26.
Individual participant dataSharing planned: Undecided

Related trials for Binge-eating Disorder

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A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
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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 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 8 Mar 2023. 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 20 Dec 2022). 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 NCT03045341, which also lists 1 linked publication.

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 8 Mar 2023.