Trial Outcomes & Findings for Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment (NCT NCT03045341)
NCT ID: NCT03045341
Last Updated: 2023-03-08
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
136 participants
Primary outcome timeframe
Post-treatment (4 months)
Results posted on
2023-03-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
BWL + Placebo
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral Weight Loss (BWL) counseling: BWL counseling
Placebo: Placebo
|
BWL + NB Medication
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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
Behavioral Weight Loss (BWL) counseling: BWL counseling
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
35
|
35
|
|
Overall Study
COMPLETED
|
29
|
27
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
Baseline characteristics by cohort
| Measure |
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
|
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
|
BWL + Placebo
n=35 Participants
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral Weight Loss (BWL) counseling: BWL counseling
Placebo: Placebo
|
BWL + NB Medication
n=35 Participants
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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
Behavioral Weight Loss (BWL) counseling: BWL counseling
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.94 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
46.03 years
STANDARD_DEVIATION 11.95 • n=7 Participants
|
46.00 years
STANDARD_DEVIATION 11.87 • n=5 Participants
|
46.99 years
STANDARD_DEVIATION 12.98 • n=4 Participants
|
46.50 years
STANDARD_DEVIATION 12.23 • n=21 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
111 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sexual Orientation
Heterosexual
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Sexual Orientation
Gay or Lesbian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sexual Orientation
Bisexual
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sexual Orientation
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Education
High School
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Education
Some College
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Education
College
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Education
More than College
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
43 Participants
n=21 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 |
Placebo
n=29 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
|
NB Medication
n=27 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
|
BWL + Placebo
n=27 Participants
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral Weight Loss (BWL) counseling: BWL counseling
Placebo: Placebo
|
BWL + NB Medication
n=29 Participants
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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
Behavioral Weight Loss (BWL) counseling: BWL counseling
|
|---|---|---|---|---|
|
Binge Eating Frequency (Continuous)
|
9.90 binge-eating episodes per month
Standard Deviation 20.31
|
7.63 binge-eating episodes per month
Standard Deviation 9.77
|
3.30 binge-eating episodes per month
Standard Deviation 5.28
|
1.97 binge-eating episodes per month
Standard Deviation 4.87
|
PRIMARY outcome
Timeframe: Post-treatment (4 months)Population: Analyses used all available data.
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.
Outcome measures
| Measure |
Placebo
n=29 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
|
NB Medication
n=26 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
|
BWL + Placebo
n=26 Participants
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral Weight Loss (BWL) counseling: BWL counseling
Placebo: Placebo
|
BWL + NB Medication
n=29 Participants
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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
Behavioral Weight Loss (BWL) counseling: BWL counseling
|
|---|---|---|---|---|
|
Body Mass Index (Percent Weight Loss)
|
1.05 percentage of baseline weight
Standard Deviation 4.26
|
-2.11 percentage of baseline weight
Standard Deviation 5.41
|
-4.42 percentage of baseline weight
Standard Deviation 5.70
|
-5.71 percentage of baseline weight
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo
n=29 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
|
NB Medication
n=27 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
|
BWL + Placebo
n=26 Participants
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral Weight Loss (BWL) counseling: BWL counseling
Placebo: Placebo
|
BWL + NB Medication
n=29 Participants
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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
Behavioral Weight Loss (BWL) counseling: BWL counseling
|
|---|---|---|---|---|
|
Number of Participants Meeting Response Criteria
|
14 Participants
|
14 Participants
|
20 Participants
|
25 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
NB Medication
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
BWL + Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
BWL + NB Medication
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=31 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
|
NB Medication
n=27 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
|
BWL + Placebo
n=29 participants at risk
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral Weight Loss (BWL) counseling: BWL counseling
Placebo: Placebo
|
BWL + NB Medication
n=31 participants at risk
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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
Behavioral Weight Loss (BWL) counseling: BWL counseling
|
|---|---|---|---|---|
|
Cardiac disorders
Hypertensive Crisis
|
0.00%
0/31 • 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%
0/27 • 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.
|
3.4%
1/29 • Number of events 1 • 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%
0/31 • 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.
|
Other adverse events
| Measure |
Placebo
n=31 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
|
NB Medication
n=27 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
|
BWL + Placebo
n=29 participants at risk
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral Weight Loss (BWL) counseling: BWL counseling
Placebo: Placebo
|
BWL + NB Medication
n=31 participants at risk
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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
Behavioral Weight Loss (BWL) counseling: BWL counseling
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
12.9%
4/31 • 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.
|
11.1%
3/27 • 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.
|
6.9%
2/29 • 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.
|
9.7%
3/31 • 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
|
19.4%
6/31 • 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.
|
40.7%
11/27 • 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.
|
24.1%
7/29 • 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.
|
25.8%
8/31 • 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
|
29.0%
9/31 • 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.
|
11.1%
3/27 • 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.
|
10.3%
3/29 • 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.
|
12.9%
4/31 • 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
|
3.2%
1/31 • 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.
|
44.4%
12/27 • 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.
|
10.3%
3/29 • 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.
|
16.1%
5/31 • 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
Dry Mouth
|
12.9%
4/31 • 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.
|
59.3%
16/27 • 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.
|
13.8%
4/29 • 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.
|
35.5%
11/31 • 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
|
22.6%
7/31 • 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.
|
48.1%
13/27 • 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.
|
31.0%
9/29 • 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.
|
35.5%
11/31 • 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
|
22.6%
7/31 • 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.
|
40.7%
11/27 • 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.
|
10.3%
3/29 • 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.
|
19.4%
6/31 • 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
|
16.1%
5/31 • 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.
|
48.1%
13/27 • 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.
|
10.3%
3/29 • 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.
|
25.8%
8/31 • 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
|
0.00%
0/31 • 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.
|
3.7%
1/27 • 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.
|
3.4%
1/29 • 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%
2/31 • 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