Trial Outcomes & Findings for Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo (NCT NCT02317744)
NCT ID: NCT02317744
Last Updated: 2017-12-22
Results Overview
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Post-treatment (at 3 months)
Results posted on
2017-12-22
Participant Flow
Participant milestones
| Measure |
Naltrexone/ Bupropion Combination
50 mg naltrexone and 300 mg bupropion per day for 3 months
Naltrexone and bupropion combination
|
Pill Placebo
Daily placebo medication for 3 months
Pill Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
Completed Treatment
|
10
|
7
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
Baseline characteristics by cohort
| Measure |
Naltrexone/ Bupropion Combination
n=12 Participants
50 mg naltrexone and 300 mg bupropion per day for 3 months
Naltrexone and bupropion combination
|
Pill Placebo
n=10 Participants
Daily placebo medication for 3 months
Pill Placebo
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Binge Eating Frequency
|
16.0 binge eating days (out of 28)
n=5 Participants
|
9.2 binge eating days (out of 28)
n=7 Participants
|
12.9 binge eating days (out of 28)
n=5 Participants
|
|
Body Mass Index (BMI)
|
35.0 kg/m^2
n=5 Participants
|
40.1 kg/m^2
n=7 Participants
|
37.3 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (at 3 months)Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Outcome measures
| Measure |
Naltrexone/ Bupropion Combination
n=11 Participants
50 mg naltrexone and 300 mg bupropion per day for 3 months
Naltrexone and bupropion combination
|
Pill Placebo
n=8 Participants
Daily placebo medication for 3 months
Pill Placebo
|
|---|---|---|
|
Binge Eating Frequency (Continuous)
|
4.4 binge eating days (out of 28)
Interval 0.0 to 28.0
|
3.0 binge eating days (out of 28)
Interval 0.0 to 16.0
|
PRIMARY outcome
Timeframe: 6 month follow-up (an average of 6 months following treatment)Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Outcome measures
| Measure |
Naltrexone/ Bupropion Combination
n=8 Participants
50 mg naltrexone and 300 mg bupropion per day for 3 months
Naltrexone and bupropion combination
|
Pill Placebo
n=8 Participants
Daily placebo medication for 3 months
Pill Placebo
|
|---|---|---|
|
Binge Eating Frequency (Continuous)
|
5.4 binge eating days (out of 28)
Interval 0.0 to 25.0
|
2.9 binge eating days (out of 28)
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: Post-treatment (at 3 months)BMI is calculated using measured height and weight.
Outcome measures
| Measure |
Naltrexone/ Bupropion Combination
n=11 Participants
50 mg naltrexone and 300 mg bupropion per day for 3 months
Naltrexone and bupropion combination
|
Pill Placebo
n=9 Participants
Daily placebo medication for 3 months
Pill Placebo
|
|---|---|---|
|
Body Mass Index (BMI)
|
34.5 kg/m^2
Interval 29.0 to 48.0
|
39.7 kg/m^2
Interval 32.0 to 47.0
|
SECONDARY outcome
Timeframe: 6 month follow-up (an average of 6 months following treatment)BMI is calculated using measured height and weight.
Outcome measures
| Measure |
Naltrexone/ Bupropion Combination
n=8 Participants
50 mg naltrexone and 300 mg bupropion per day for 3 months
Naltrexone and bupropion combination
|
Pill Placebo
n=8 Participants
Daily placebo medication for 3 months
Pill Placebo
|
|---|---|---|
|
Body Mass Index (BMI)
|
35.9 kg/m^2
Interval 28.0 to 48.0
|
40.3 kg/m^2
Interval 34.0 to 45.0
|
Adverse Events
Naltrexone/ Bupropion Combination
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Pill Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone/ Bupropion Combination
n=11 participants at risk
50 mg naltrexone and 300 mg bupropion per day for 3 months
Naltrexone and bupropion combination
|
Pill Placebo
n=8 participants at risk
Daily placebo medication for 3 months
Pill Placebo
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
27.3%
3/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
62.5%
5/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
0.00%
0/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
12.5%
1/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
25.0%
2/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Dizziness
|
45.5%
5/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
12.5%
1/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Dry Mouth
|
18.2%
2/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
25.0%
2/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Headache
|
27.3%
3/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
50.0%
4/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Insomnia
|
45.5%
5/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
12.5%
1/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
25.0%
2/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Hot Flush
|
36.4%
4/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
12.5%
1/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Fatigue
|
18.2%
2/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
12.5%
1/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Common Cold
|
9.1%
1/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
0.00%
0/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
Gastrointestinal disorders
Abdominal Pain
|
18.2%
2/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
12.5%
1/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Sinusitis
|
0.00%
0/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
12.5%
1/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Sexual Dysfunction
|
0.00%
0/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
0.00%
0/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
|
General disorders
Depression
|
0.00%
0/11 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
12.5%
1/8 • 3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place