Trial · NCT03946111

Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders

NCT03946111, Phase 2, Phase 3, Completed, Yale University; results first posted 2025-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders. Trials, record NCT03946111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03946111

On this page

Trial

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

Title: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders
NCT number: NCT03946111
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 3 participants, actual
Lead sponsor: Yale University
Conditions: Binge-Eating Disorder, Obesity
Interventions: Naltrexone and Bupropion, Placebo
First posted: 2019-05-10
Last updated: 2026-01-09
Results first posted: 2025-12-17

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Change in Binge-Eating Frequency	From baseline interview at study enrollment to 3 months after the 12-week treatment.	Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Primary	Change in Binge-Eating Frequency	From post-treatment to the 6-month follow-up	Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Primary	Change in Binge-Eating Frequency	From post-treatment to the 12-month follow-up	Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Primary	Percent Change in Weight	From baseline interview at study enrollment to 3 months after the 12-week treatment.	Negative values indicate weight loss and positive values indicate weight gain.
Primary	Percent Change in Weight	From post-treatment to the 6-month follow-up	Negative values indicate weight loss and positive values indicate weight gain.
Primary	Percent Change in Weight	From post-treatment to the 12-month follow-up	Negative values indicate weight loss and positive values indicate weight gain.
Secondary	Binge-Eating Remission	12-weeks	Categorical: zero binges/28 days
Secondary	Binge-Eating Remission	6-month follow-up	Categorical: zero binges/28 days
Secondary	Binge-Eating Remission	12-month follow-up	Categorical: zero binges/28 days
Secondary	Change in Eating-Disorder Psychopathology (Continuous)	From baseline interview at study enrollment to 3 months after the 12-week treatment.	Eating-disorder psychopathology is assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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	From baseline interview at study enrollment to 3 months after the 12-week treatment.	episodes per past 28 days	MEAN
PRIMARY	Change in Binge-Eating Frequency	From post-treatment to the 6-month follow-up	episodes per past 28 days	MEAN
PRIMARY	Change in Binge-Eating Frequency	From post-treatment to the 12-month follow-up	episodes per past 28 days	MEAN
PRIMARY	Percent Change in Weight	From baseline interview at study enrollment to 3 months after the 12-week treatment.	percent change	MEAN
PRIMARY	Percent Change in Weight	From post-treatment to the 6-month follow-up	percent change	MEAN
PRIMARY	Percent Change in Weight	From post-treatment to the 12-month follow-up	percent change	MEAN
SECONDARY	Binge-Eating Remission	12-weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Binge-Eating Remission	6-month follow-up	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Binge-Eating Remission	12-month follow-up	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Eating-Disorder Psychopathology (Continuous)	From baseline interview at study enrollment to 3 months after the 12-week treatment.	score on a scale	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group30

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	Naltrexone/Bupropion	-14	Standard Deviation 0	episodes per past 28 days
Change in Binge-Eating Frequency	Placebo	-17.00	Standard Deviation 18.38	episodes per past 28 days
Change in Binge-Eating Frequency	Naltrexone/Bupropion	0	Standard Deviation 0	episodes per past 28 days
Change in Binge-Eating Frequency	Placebo	3	Standard Deviation 0	episodes per past 28 days
Change in Binge-Eating Frequency	Naltrexone/Bupropion	4	Standard Deviation 0	episodes per past 28 days
Change in Binge-Eating Frequency	Placebo	1.50	Standard Deviation 2.12	episodes per past 28 days
Percent Change in Weight	Naltrexone/Bupropion	2.71	Standard Deviation 0	percent change
Percent Change in Weight	Placebo	-1.73	Standard Deviation 11.35	percent change
Percent Change in Weight	Naltrexone/Bupropion	5.82	Standard Deviation 0.0	percent change
Percent Change in Weight	Placebo	5.61	Standard Deviation 8.88	percent change

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Naltrexone/Bupropion	1
Overall Study	STARTED	Placebo	2
Overall Study	COMPLETED	Naltrexone/Bupropion	1
Overall Study	COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	Naltrexone/Bupropion	0
Overall Study	NOT COMPLETED	Placebo	0

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	At risk
other	Constipation	Gastrointestinal disorders	Naltrexone/Bupropion	1
other	Constipation	Gastrointestinal disorders	Placebo	2
other	Diarrhea	Gastrointestinal disorders	Naltrexone/Bupropion	1
other	Diarrhea	Gastrointestinal disorders	Placebo	2
other	Dry mouth	Gastrointestinal disorders	Naltrexone/Bupropion	1
other	Dry mouth	Gastrointestinal disorders	Placebo	2
other	Nausea	Gastrointestinal disorders	Naltrexone/Bupropion	1
other	Nausea	Gastrointestinal disorders	Placebo	2
other	Vomiting	Gastrointestinal disorders	Naltrexone/Bupropion	1
other	Vomiting	Gastrointestinal disorders	Placebo	2

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	Naltrexone/Bupropion	0	1
Total, all-cause mortality	Placebo	0	2
Total, other adverse events	Naltrexone/Bupropion	0	1
Total, other adverse events	Placebo	1	2
Total, serious adverse events	Naltrexone/Bupropion	0	1
Total, serious adverse events	Placebo	0	2

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
R01DK114075	Cognitive-Behavioral and Pharmacologic Treatment of Binge Eating Disorder	GRILO, CARLOS M	YALE UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2018 to 2022

Source NIH RePORTER

Trial comparisons5

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

Comparison	Source
Naltrexone/Bupropion vs Placebo: Binge-Eating Remission	Trial comparisons
Naltrexone/Bupropion vs Placebo: deaths from any cause	Trial comparisons
Naltrexone/Bupropion vs Placebo: Binge-Eating Remission	Trial comparisons
Naltrexone/Bupropion vs Placebo: Binge-Eating Remission	Trial comparisons
Naltrexone/Bupropion 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/NCT03946111

GET https://conductscience.org/api/trials/v1/NCT03946111/results?page=2

API reference For AI assistants