Trial · NCT03047005

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

NCT03047005, Phase 2, Phase 3, Completed, Yale University; results first posted 2023-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy. Trials, record NCT03047005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03047005

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Trial

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

Title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
NCT number: NCT03047005
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 68 participants, actual
Lead sponsor: Yale University
Conditions: Binge-Eating Disorder, Obesity
Interventions: NB medication (Naltrexone Bupropion combination), Placebo
First posted: 2017-02-08
Last updated: 2024-02-02
Results first posted: 2023-05-06

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Binge Eating Frequency (Continuous)	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).
Primary	Change in Body Mass Index	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.
Secondary	Binge Eating Frequency (Continuous)	6-Month Follow-up	Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Secondary	Binge Eating Frequency (Continuous)	12-Month Follow-up	Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Secondary	Change in Body Mass Index (BMI)	Baseline to 6-Month Follow-up	BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.
Secondary	Change in Body Mass Index	Baseline to 12-Month Follow-up	BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight 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	Binge Eating Frequency (Continuous)	Post-treatment (4 months)	binge eating days per month	MEAN
PRIMARY	Change in Body Mass Index	baseline and Post-treatment (4 months)	percentage weight change	MEAN
SECONDARY	Binge Eating Frequency (Continuous)	6-Month Follow-up	eating events/28 days	MEAN
SECONDARY	Binge Eating Frequency (Continuous)	12-Month Follow-up	eating events/28 days	MEAN
SECONDARY	Change in Body Mass Index (BMI)	Baseline to 6-Month Follow-up	percentage change in BMI	MEAN
SECONDARY	Change in Body Mass Index	Baseline to 12-Month Follow-up	percentage change in BMI	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
Binge Eating Frequency (Continuous)	NB Medication	0.86	Standard Deviation 2.15	binge eating days per month
Binge Eating Frequency (Continuous)	Placebo	3.25	Standard Deviation 7.06	binge eating days per month
Change in Body Mass Index	NB Medication	-0.03	Standard Deviation .05	percentage weight change
Change in Body Mass Index	Placebo	.01	Standard Deviation .04	percentage weight change
Binge Eating Frequency (Continuous)	NB Medication	1.57	Standard Deviation 4.42	eating events/28 days
Binge Eating Frequency (Continuous)	Placebo	2.43	Standard Deviation 4.92	eating events/28 days
Binge Eating Frequency (Continuous)	NB Medication	3.35	Standard Deviation 6.58	eating events/28 days
Binge Eating Frequency (Continuous)	Placebo	2.77	Standard Deviation 6.15	eating events/28 days
Change in Body Mass Index (BMI)	NB Medication	.004	Standard Deviation .065	percentage change in BMI
Change in Body Mass Index (BMI)	Placebo	.026	Standard Deviation .063	percentage change in BMI

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	32
Overall Study	STARTED	Placebo	34
Overall Study	COMPLETED	NB Medication	29
Overall Study	COMPLETED	Placebo	28
Overall Study	NOT COMPLETED	NB Medication	3
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events20

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	Constipation	Gastrointestinal disorders	NB Medication	10	32
other	Constipation	Gastrointestinal disorders	Placebo	5	34
other	Diarrhea	Gastrointestinal disorders	NB Medication	2	32
other	Diarrhea	Gastrointestinal disorders	Placebo	5	34
other	Nausea	Gastrointestinal disorders	NB Medication	8	32
other	Nausea	Gastrointestinal disorders	Placebo	3	34
other	Vomiting	Gastrointestinal disorders	NB Medication	3	32
other	Vomiting	Gastrointestinal disorders	Placebo	3	34
other	Dizziness	General disorders	NB Medication	4	32
other	Dizziness	General disorders	Placebo	4	34

1 to 10 of 20Source ClinicalTrials.gov

See all 20 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	32
Total, all-cause mortality	Placebo	0	34
Total, other adverse events	NB Medication	21	32
Total, other adverse events	Placebo	18	34
Total, serious adverse events	NB Medication	0	32
Total, serious adverse events	Placebo	0	34

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
R01DK049587	Behavioral and Pharmacologic Treatment of Binge Eating and Obesity	GRILO, CARLOS M	YALE UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2002 to 2020

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/NCT03047005

GET https://conductscience.org/api/trials/v1/NCT03047005/registered

API reference For AI assistants