Trial · NCT03045341

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

NCT03045341, Phase 2, Phase 3, Completed, Yale University; results first posted 2022-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment. Trials, record NCT03045341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03045341

On this page

Trial

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

Title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
NCT number: NCT03045341
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 136 participants, actual
Lead sponsor: Yale University
Conditions: Binge-eating Disorder, Obesity
Interventions: NB medication (Naltrexone Bupropion combination), Behavioral Weight Loss (BWL) counseling, Placebo
First posted: 2017-02-07
Last updated: 2023-03-08
Results first posted: 2022-12-20

Source ClinicalTrials.gov

Registered outcomes3

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	Body Mass Index (Percent Weight Loss)	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.
Secondary	Number of Participants Meeting Response Criteria	Post-treatment (4 months)	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.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Binge Eating Frequency (Continuous)	Post-treatment (4 months)		binge-eating episodes per month	MEAN
PRIMARY	Body Mass Index (Percent Weight Loss)	Post-treatment (4 months)	Analyses used all available data.	percentage of baseline weight	MEAN
SECONDARY	Number of Participants Meeting Response Criteria	Post-treatment (4 months)		Participants	COUNT_OF_PARTICIPANTS

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)	Placebo	9.90	Standard Deviation 20.31	binge-eating episodes per month
Binge Eating Frequency (Continuous)	NB Medication	7.63	Standard Deviation 9.77	binge-eating episodes per month
Binge Eating Frequency (Continuous)	BWL + Placebo	3.30	Standard Deviation 5.28	binge-eating episodes per month
Binge Eating Frequency (Continuous)	BWL + NB Medication	1.97	Standard Deviation 4.87	binge-eating episodes per month
Body Mass Index (Percent Weight Loss)	Placebo	1.05	Standard Deviation 4.26	percentage of baseline weight
Body Mass Index (Percent Weight Loss)	NB Medication	-2.11	Standard Deviation 5.41	percentage of baseline weight
Body Mass Index (Percent Weight Loss)	BWL + Placebo	-4.42	Standard Deviation 5.70	percentage of baseline weight
Body Mass Index (Percent Weight Loss)	BWL + NB Medication	-5.71	Standard Deviation 5.85	percentage of baseline weight
Number of Participants Meeting Response Criteria	Placebo	14		Participants
Number of Participants Meeting Response Criteria	NB Medication	14		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	34
Overall Study	STARTED	NB Medication	32
Overall Study	STARTED	BWL + Placebo	35
Overall Study	STARTED	BWL + NB Medication	35
Overall Study	COMPLETED	Placebo	29
Overall Study	COMPLETED	NB Medication	27
Overall Study	COMPLETED	BWL + Placebo	27
Overall Study	COMPLETED	BWL + NB Medication	29
Overall Study	NOT COMPLETED	Placebo	5
Overall Study	NOT COMPLETED	NB Medication	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events40

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	Placebo	4	31
other	Anxiety	Psychiatric disorders	NB Medication	3	27
other	Anxiety	Psychiatric disorders	BWL + Placebo	2	29
other	Anxiety	Psychiatric disorders	BWL + NB Medication	3	31
other	Constipation	Gastrointestinal disorders	Placebo	6	31
other	Constipation	Gastrointestinal disorders	NB Medication	11	27
other	Constipation	Gastrointestinal disorders	BWL + Placebo	7	29
other	Constipation	Gastrointestinal disorders	BWL + NB Medication	8	31
other	Diarrhea	Gastrointestinal disorders	Placebo	9	31
other	Diarrhea	Gastrointestinal disorders	NB Medication	3	27

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	31
Total, all-cause mortality	NB Medication	0	27
Total, all-cause mortality	BWL + Placebo	0	29
Total, all-cause mortality	BWL + NB Medication	0	31
Total, other adverse events	Placebo	18	31
Total, other adverse events	NB Medication	24	27
Total, other adverse events	BWL + Placebo	20	29
Total, other adverse events	BWL + NB Medication	24	31
Total, serious adverse events	Placebo	0	31
Total, serious adverse events	NB Medication	0	27

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36285406	DERIVED

Source PubMed

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 comparisons0

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

None in this release.

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/NCT03045341

GET https://conductscience.org/api/trials/v1/NCT03045341/events?page=2

API reference For AI assistants