Trial Outcomes & Findings for Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders (NCT NCT03946111)

NCT ID: NCT03946111

Last Updated: 2026-01-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 3 participants
• Primary outcome timeframe: From baseline interview at study enrollment to 3 months after the 12-week treatment.
• Results posted on: 2026-01-09

Participant Flow

Participant milestones

Measure	Naltrexone/Bupropion Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.	Total n=3 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 0.0 • n=8 Participants	43 years STANDARD_DEVIATION 19.8 • n=7 Participants	44.33 years STANDARD_DEVIATION 14.19 • n=15 Participants
Sex: Female, Male Female	1 Participants n=8 Participants	2 Participants n=7 Participants	3 Participants n=15 Participants
Sex: Female, Male Male	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=8 Participants	2 Participants n=7 Participants	3 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	1 Participants n=7 Participants	1 Participants n=15 Participants
Race (NIH/OMB) White	1 Participants n=8 Participants	1 Participants n=7 Participants	2 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=15 Participants
Region of Enrollment United States	1 participants n=8 Participants	2 participants n=7 Participants	3 participants n=15 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Binge-Eating Frequency	-14 episodes per past 28 days Standard Deviation 0	-17.00 episodes per past 28 days Standard Deviation 18.38

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Binge-Eating Frequency	0 episodes per past 28 days Standard Deviation 0	3 episodes per past 28 days Standard Deviation 0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Binge-Eating Frequency	4 episodes per past 28 days Standard Deviation 0	1.50 episodes per past 28 days Standard Deviation 2.12

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Percent Change in Weight	2.71 percent change Standard Deviation 0	-1.73 percent change Standard Deviation 11.35

PRIMARY outcome

Timeframe: From post-treatment to the 6-month follow-up

Negative values indicate weight loss and positive values indicate weight gain.

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Percent Change in Weight	5.82 percent change Standard Deviation 0.0	5.61 percent change Standard Deviation 8.88

PRIMARY outcome

Timeframe: From post-treatment to the 12-month follow-up

Negative values indicate weight loss and positive values indicate weight gain.

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Percent Change in Weight	12.33 percent change Standard Deviation 0.0	3.32 percent change Standard Deviation 5.24

SECONDARY outcome

Timeframe: 12-weeks

Categorical: zero binges/28 days

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Binge-Eating Remission	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 6-month follow-up

Categorical: zero binges/28 days

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Binge-Eating Remission	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12-month follow-up

Categorical: zero binges/28 days

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Binge-Eating Remission	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Eating-Disorder Psychopathology (Continuous)	-1.07 score on a scale Standard Deviation 0.0	-0.33 score on a scale Standard Deviation 2.49

SECONDARY outcome

Timeframe: From post-treatment to the 6-month follow-up

Eating-disorder psychopathology is a continuous variable as 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).

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Eating-Disorder Psychopathology (Continuous)	0.14 score on a scale Standard Deviation 0.0	0.09 score on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: From post-treatment to the 12-month follow-up

Eating-disorder psychopathology is a continuous variable as 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).

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Eating-Disorder Psychopathology (Continuous)	0.76 score on a scale Standard Deviation 0	-0.22 score on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: From baseline interview at study enrollment to 3 months after the 12-week treatment.

Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Depressive Symptoms	-1.0 score on a scale Standard Deviation 0.0	-5.50 score on a scale Standard Deviation 4.95

SECONDARY outcome

Timeframe: From post-treatment to the 6-month follow-up

Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Depressive Symptoms	-7.0 score on a scale Standard Deviation 0.0	-2.50 score on a scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: From post-treatment to the 12-month follow-up

Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).

Outcome measures

Measure	Naltrexone/Bupropion n=1 Participants Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Depressive Symptoms	-1.0 score on a scale Standard Deviation 0.0	2.50 score on a scale Standard Deviation 2.12

Adverse Events

Naltrexone/Bupropion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Naltrexone/Bupropion n=1 participants at risk Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.	Placebo n=2 participants at risk Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Gastrointestinal disorders Constipation	0.00% 0/1 • 12 months	0.00% 0/2 • 12 months
Gastrointestinal disorders Diarrhea	0.00% 0/1 • 12 months	0.00% 0/2 • 12 months
Gastrointestinal disorders Dry mouth	0.00% 0/1 • 12 months	0.00% 0/2 • 12 months
Gastrointestinal disorders Nausea	0.00% 0/1 • 12 months	0.00% 0/2 • 12 months
Gastrointestinal disorders Vomiting	0.00% 0/1 • 12 months	0.00% 0/2 • 12 months
General disorders Dizziness	0.00% 0/1 • 12 months	0.00% 0/2 • 12 months
General disorders Headache	0.00% 0/1 • 12 months	0.00% 0/2 • 12 months
General disorders Insomnia	0.00% 0/1 • 12 months	0.00% 0/2 • 12 months
Psychiatric disorders Anxiety	0.00% 0/1 • 12 months	50.0% 1/2 • 12 months

Additional Information

Dr. Carlos M. Grilo

Yale School of Medicine

Phone: 2037857210

Email: carlos.grilo@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place