Trial Outcomes & Findings for Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy (NCT NCT03047005)

NCT ID: NCT03047005

Last Updated: 2024-02-02

Results Overview

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 68 participants
• Primary outcome timeframe: Post-treatment (4 months)
• Results posted on: 2024-02-02

Participant Flow

The main study (acute treatment results) can be found in NCT03045341. Two participants dropped prior to beginning the medication.

Participant milestones

Measure	NB Medication Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Overall Study STARTED	32	34
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	NB Medication n=32 Participants Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=34 Participants Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo	Total n=66 Participants Total of all reporting groups
Age, Continuous	50.40 years STANDARD_DEVIATION 11.70 • n=93 Participants	43.60 years STANDARD_DEVIATION 11.80 • n=4 Participants	46.92 years STANDARD_DEVIATION 12.15 • n=27 Participants
Sex/Gender, Customized Men	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Sex/Gender, Customized Women	28 Participants n=93 Participants	28 Participants n=4 Participants	56 Participants n=27 Participants
Sex/Gender, Customized Other	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants	28 Participants n=4 Participants	57 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants	22 Participants n=4 Participants	47 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	NB Medication n=29 Participants Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=28 Participants Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Binge Eating Frequency (Continuous)	0.86 binge eating days per month Standard Deviation 2.15	3.25 binge eating days per month Standard Deviation 7.06

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	NB Medication n=29 Participants Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=26 Participants Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Change in Body Mass Index	-0.03 percentage weight change Standard Deviation .05	.01 percentage weight change Standard Deviation .04

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	NB Medication n=23 Participants Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=21 Participants Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Binge Eating Frequency (Continuous)	1.57 eating events/28 days Standard Deviation 4.42	2.43 eating events/28 days Standard Deviation 4.92

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	NB Medication n=17 Participants Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=22 Participants Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Binge Eating Frequency (Continuous)	3.35 eating events/28 days Standard Deviation 6.58	2.77 eating events/28 days Standard Deviation 6.15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	NB Medication n=23 Participants Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=21 Participants Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Change in Body Mass Index (BMI)	.004 percentage change in BMI Standard Deviation .065	.026 percentage change in BMI Standard Deviation .063

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	NB Medication n=16 Participants Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=22 Participants Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Change in Body Mass Index	.025 percentage change in BMI Standard Deviation .079	.042 percentage change in BMI Standard Deviation .076

Adverse Events

NB Medication

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	NB Medication n=32 participants at risk Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=34 participants at risk Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Cardiac disorders Hypertensive Crisis	0.00% 0/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	0.00% 0/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.

Other adverse events

Measure	NB Medication n=32 participants at risk Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form. NB medication (Naltrexone Bupropion combination): NB medication	Placebo n=34 participants at risk Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Placebo: Placebo
Gastrointestinal disorders Constipation	31.2% 10/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	14.7% 5/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
Gastrointestinal disorders Diarrhea	6.2% 2/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	14.7% 5/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
Gastrointestinal disorders Nausea	25.0% 8/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	8.8% 3/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
Gastrointestinal disorders Vomiting	9.4% 3/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	8.8% 3/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
General disorders Dizziness	12.5% 4/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	11.8% 4/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
General disorders Dry Mouth	31.2% 10/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	8.8% 3/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
General disorders Headache	28.1% 9/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	11.8% 4/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
General disorders Insomnia	21.9% 7/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	26.5% 9/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.
Psychiatric disorders Anxiety	6.2% 2/32 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.	17.6% 6/34 • Month 1 Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \[all available data\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \[all available data\] who reported the adverse event over the course of the study.

Additional Information

Dr. Carlos Grilo

Yale University

Phone: 203 785 7210

Email: carlos.grilo@yale.edu

Results disclosure agreements

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