Trial Outcomes & Findings for Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder (NCT NCT03539900)
NCT ID: NCT03539900
Last Updated: 2024-04-03
Results Overview
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
89 participants
Primary outcome timeframe
Post-treatment (3 months)
Results posted on
2024-04-03
Participant Flow
Participant milestones
| Measure |
NB Medication
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
Placebo
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
46
|
|
Overall Study
COMPLETED
|
38
|
44
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Baseline characteristics by cohort
| Measure |
NB Medication
n=43 Participants
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
Placebo
n=46 Participants
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex/Gender, Customized
Men
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Women
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Another gender
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
46 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Sexual Orientation
Heterosexual
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sexual Orientation
Homosexual
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
High School
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Education
Some College
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Education
College
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Education
More than College
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (3 months)Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=43 Participants
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
|---|---|---|
|
Change in Binge Eating Frequency
|
5.4 binge-eating episodes per month
Standard Deviation 9.6
|
6.4 binge-eating episodes per month
Standard Deviation 10.6
|
PRIMARY outcome
Timeframe: Post-treatment (3 months)BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at posttreatment\] - \[BMI at baseline\])/\[BMI at baseline\]. Negative values indicate loss.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=43 Participants
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
|---|---|---|
|
Percent BMI Change
|
-0.5 percent BMI change
Standard Deviation 8.9
|
-8.0 percent BMI change
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 6 months post-treatmentBinge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.
Outcome measures
| Measure |
Placebo
n=23 Participants
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=24 Participants
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
|---|---|---|
|
Change in Binge Eating Frequency
|
6.00 binge-eating episodes per month
Standard Deviation 9.54
|
4.67 binge-eating episodes per month
Standard Deviation 6.29
|
SECONDARY outcome
Timeframe: 12 months post-treatmentBinge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=22 Participants
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
|---|---|---|
|
Change in Binge Eating Frequency
|
5.33 binge-eating episodes per month
Standard Deviation 6.82
|
6.36 binge-eating episodes per month
Standard Deviation 14.87
|
SECONDARY outcome
Timeframe: 6 months post-treatmentBMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at 6 month followup\] - \[BMI at posttreatment\])/\[BMI at posttreatment\]. Negative values indicate loss.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=13 Participants
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
|---|---|---|
|
Body Mass Index
|
0.05 percent BMI change
Standard Deviation 4.28
|
0.04 percent BMI change
Standard Deviation 10.51
|
SECONDARY outcome
Timeframe: 12 months post-treatmentBMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at 12 month followup\] - \[BMI at posttreatment\])/\[BMI at posttreatment\]. Negative values indicate loss.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=10 Participants
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
|---|---|---|
|
Body Mass Index
|
3.43 percent BMI change
Standard Deviation 7.86
|
-0.20 percent BMI change
Standard Deviation 12.18
|
Adverse Events
NB Medication
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NB Medication
n=43 participants at risk
Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
|
Placebo
n=46 participants at risk
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
7.0%
3/43 • 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.
|
0.00%
0/46 • 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.
|
|
Gastrointestinal disorders
Constipation
|
23.3%
10/43 • 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.
|
6.5%
3/46 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • 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.
|
10.9%
5/46 • 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.
|
|
General disorders
Dizziness
|
16.3%
7/43 • 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.
|
8.7%
4/46 • 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.
|
|
Gastrointestinal disorders
Dry Mouth
|
32.6%
14/43 • 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.
|
8.7%
4/46 • 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.
|
|
General disorders
Headache
|
4.7%
2/43 • 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.
|
19.6%
9/46 • 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.
|
|
General disorders
Insomnia
|
4.7%
2/43 • 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.
|
13.0%
6/46 • 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.
|
|
Gastrointestinal disorders
Nausea
|
14.0%
6/43 • 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.
|
8.7%
4/46 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
3/43 • 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.
|
8.7%
4/46 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place