Trial · NCT03539900

Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

NCT03539900, Phase 2, Phase 3, Completed, Yale University; results first posted 2023-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder. Trials, record NCT03539900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03539900

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
NCT number: NCT03539900
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 89 participants, actual
Lead sponsor: Yale University
Conditions: Binge-Eating Disorder
Interventions: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination, Placebo
First posted: 2018-05-29
Last updated: 2024-04-03
Results first posted: 2023-07-24

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Binge Eating Frequency	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."
Primary	Percent BMI Change	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.
Secondary	Change in Binge Eating Frequency	6 months post-treatment	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.
Secondary	Change in Binge Eating Frequency	12 months post-treatment	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.
Secondary	Body Mass Index	6 months post-treatment	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.
Secondary	Body Mass Index	12 months post-treatment	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Binge Eating Frequency	Post-treatment (3 months)	binge-eating episodes per month	MEAN
PRIMARY	Percent BMI Change	Post-treatment (3 months)	percent BMI change	MEAN
SECONDARY	Change in Binge Eating Frequency	6 months post-treatment	binge-eating episodes per month	MEAN
SECONDARY	Change in Binge Eating Frequency	12 months post-treatment	binge-eating episodes per month	MEAN
SECONDARY	Body Mass Index	6 months post-treatment	percent BMI change	MEAN
SECONDARY	Body Mass Index	12 months post-treatment	percent BMI change	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Binge Eating Frequency	NB Medication	6.4	Standard Deviation 10.6	binge-eating episodes per month
Change in Binge Eating Frequency	Placebo	5.4	Standard Deviation 9.6	binge-eating episodes per month
Percent BMI Change	NB Medication	-8.0	Standard Deviation 11.3	percent BMI change
Percent BMI Change	Placebo	-0.5	Standard Deviation 8.9	percent BMI change
Change in Binge Eating Frequency	NB Medication	4.67	Standard Deviation 6.29	binge-eating episodes per month
Change in Binge Eating Frequency	Placebo	6.00	Standard Deviation 9.54	binge-eating episodes per month
Change in Binge Eating Frequency	NB Medication	6.36	Standard Deviation 14.87	binge-eating episodes per month
Change in Binge Eating Frequency	Placebo	5.33	Standard Deviation 6.82	binge-eating episodes per month
Body Mass Index	NB Medication	0.04	Standard Deviation 10.51	percent BMI change
Body Mass Index	Placebo	0.05	Standard Deviation 4.28	percent BMI change

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NB Medication	43
Overall Study	STARTED	Placebo	46
Overall Study	COMPLETED	NB Medication	38
Overall Study	COMPLETED	Placebo	44
Overall Study	NOT COMPLETED	NB Medication	5
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anxiety	Psychiatric disorders	NB Medication	3	43
other	Anxiety	Psychiatric disorders	Placebo	0	46
other	Constipation	Gastrointestinal disorders	NB Medication	10	43
other	Constipation	Gastrointestinal disorders	Placebo	3	46
other	Diarrhea	Gastrointestinal disorders	NB Medication	1	43
other	Diarrhea	Gastrointestinal disorders	Placebo	5	46
other	Dizziness	General disorders	NB Medication	7	43
other	Dizziness	General disorders	Placebo	4	46
other	Dry Mouth	Gastrointestinal disorders	NB Medication	14	43
other	Dry Mouth	Gastrointestinal disorders	Placebo	4	46

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NB Medication	0	43
Total, all-cause mortality	Placebo	0	46
Total, other adverse events	NB Medication	26	43
Total, other adverse events	Placebo	26	46
Total, serious adverse events	NB Medication	0	43
Total, serious adverse events	Placebo	0	46

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK112771	Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder	GRILO, CARLOS M; MCKEE, SHERRY ANN	YALE UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2017 to 2021

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
NB Medication vs Placebo: deaths from any cause	Trial comparisons
NB Medication vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03539900

GET https://conductscience.org/api/trials/v1/NCT03539900/registered

API reference For AI assistants