Trial Outcomes & Findings for Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a) (NCT NCT04605081)
NCT ID: NCT04605081
Last Updated: 2026-08-26
Results Overview
Percent weight loss is calculated based on change from pre-treatment to post-treatment at 12 weeks. Negative values indicate weight loss.
COMPLETED
PHASE2/PHASE3
24 participants
From baseline at study enrollment to after the 12-week treatment
2026-08-26
Participant Flow
Participant milestones
| Measure |
Naltrexone+Bupropion Medication
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)
Baseline characteristics by cohort
| Measure |
Naltrexone+Bupropion Medication
n=11 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=13 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.00 years
STANDARD_DEVIATION 10.14 • n=31 Participants
|
45.62 years
STANDARD_DEVIATION 9.11 • n=49 Participants
|
47.62 years
STANDARD_DEVIATION 9.64 • n=80 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=31 Participants
|
12 Participants
n=49 Participants
|
22 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=31 Participants
|
9 Participants
n=49 Participants
|
18 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=31 Participants
|
10 Participants
n=49 Participants
|
19 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: At post-treatment after the 12-week treatmentRelapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=11 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=12 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Loss-of-control Eating Relapse
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From post-treatment to the 6-month follow-upRelapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=7 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=7 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Loss-of-control Eating Relapse
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From post-treatment to the 12-month follow-upRelapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=6 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=5 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Loss-of-control Eating Relapse
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline at study enrollment to after the 12-week treatmentPercent weight loss is calculated based on change from pre-treatment to post-treatment at 12 weeks. Negative values indicate weight loss.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=11 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=12 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Percent Weight Change
|
-1.54 percent change
Standard Deviation 2.08
|
-0.27 percent change
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: From post-treatment to the 6-month follow-upPercent weight loss is calculated based on change from post-treatment to the 6-month follow-up. Negative values indicate weight loss.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=9 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=8 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Percent Weight Change
|
4.48 percent change
Standard Deviation 5.27
|
1.35 percent change
Standard Deviation 7.84
|
PRIMARY outcome
Timeframe: From post-treatment to the 12-month follow-upPercent weight loss is calculated based on change from post-treatment to the 12-month follow-up. Negative values indicate weight loss.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=7 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=6 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Percent Weight Change
|
8.91 percent change
Standard Deviation 6.37
|
2.11 percent change
Standard Deviation 7.59
|
SECONDARY outcome
Timeframe: At post-treatment after the 12-week treatmentLoss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=11 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=12 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Loss-of-control Eating Frequency
|
2.64 episodes per the past 28 days
Standard Deviation 3.50
|
1.08 episodes per the past 28 days
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: 6-month follow-up after the end of treatmentLoss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=9 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=8 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Loss-of-control Eating Frequency
|
8.78 episodes per the past 28 days
Standard Deviation 15.23
|
1.38 episodes per the past 28 days
Standard Deviation 3.50
|
SECONDARY outcome
Timeframe: 12-month follow-up after the end of treatmentLoss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=7 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=6 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Loss-of-control Eating Frequency
|
4.86 episodes per the past 28 days
Standard Deviation 4.02
|
0.00 episodes per the past 28 days
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: At post-treatment after the 12-week treatmentEating-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 Medication
n=11 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=12 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Eating Disorder Psychopathology
|
0.94 scores on a scale ranging from 0-6
Standard Deviation 0.74
|
0.91 scores on a scale ranging from 0-6
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 6-month follow-up after the end of treatmentEating-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 Medication
n=9 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=8 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Eating Disorder Psychopathology
|
1.24 scores on a scale ranging from 0-6
Standard Deviation 0.70
|
0.78 scores on a scale ranging from 0-6
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 12-month follow-up after the end of treatmentEating-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 Medication
n=7 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=6 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Eating Disorder Psychopathology
|
1.23 scores on a scale ranging from 0-6
Standard Deviation 0.85
|
0.57 scores on a scale ranging from 0-6
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: At post-treatment after the 12-week treatmentDepressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=11 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=12 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Depressive Symptoms
|
1.91 scores on a scale ranging from 0-27
Standard Deviation 1.70
|
2.42 scores on a scale ranging from 0-27
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: 6-month follow-up after the end of treatmentDepressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=9 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=8 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Depressive Symptoms
|
4.67 scores on a scale ranging from 0-27
Standard Deviation 4.30
|
1.25 scores on a scale ranging from 0-27
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: 12-month follow-up after the end of treatmentDepressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Outcome measures
| Measure |
Naltrexone+Bupropion Medication
n=7 Participants
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=6 Participants
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Depressive Symptoms
|
7.00 scores on a scale ranging from 0-27
Standard Deviation 6.32
|
1.00 scores on a scale ranging from 0-27
Standard Deviation 1.26
|
Adverse Events
Naltrexone+Bupropion Medication
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone+Bupropion Medication
n=11 participants at risk
NB medication will be taken daily in pill form for twelve weeks.
|
Placebo
n=13 participants at risk
Placebo will be inactive and taken daily in pill form for twelve weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
18.2%
2/11 • From enrollment until end of treatment, up to 12 weeks
|
0.00%
0/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Psychiatric disorders
Anxiety
|
27.3%
3/11 • From enrollment until end of treatment, up to 12 weeks
|
7.7%
1/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
18.2%
2/11 • From enrollment until end of treatment, up to 12 weeks
|
15.4%
2/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
54.5%
6/11 • From enrollment until end of treatment, up to 12 weeks
|
0.00%
0/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • From enrollment until end of treatment, up to 12 weeks
|
7.7%
1/13 • From enrollment until end of treatment, up to 12 weeks
|
|
General disorders
Dizziness
|
9.1%
1/11 • From enrollment until end of treatment, up to 12 weeks
|
7.7%
1/13 • From enrollment until end of treatment, up to 12 weeks
|
|
General disorders
Dry Mouth
|
27.3%
3/11 • From enrollment until end of treatment, up to 12 weeks
|
0.00%
0/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Nervous system disorders
Fatigue
|
9.1%
1/11 • From enrollment until end of treatment, up to 12 weeks
|
0.00%
0/13 • From enrollment until end of treatment, up to 12 weeks
|
|
General disorders
Headache
|
9.1%
1/11 • From enrollment until end of treatment, up to 12 weeks
|
0.00%
0/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Nervous system disorders
Hot Flush
|
36.4%
4/11 • From enrollment until end of treatment, up to 12 weeks
|
7.7%
1/13 • From enrollment until end of treatment, up to 12 weeks
|
|
General disorders
Insomnia
|
36.4%
4/11 • From enrollment until end of treatment, up to 12 weeks
|
7.7%
1/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • From enrollment until end of treatment, up to 12 weeks
|
7.7%
1/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/11 • From enrollment until end of treatment, up to 12 weeks
|
7.7%
1/13 • From enrollment until end of treatment, up to 12 weeks
|
|
Nervous system disorders
Tingling Sensation Back of Legs
|
9.1%
1/11 • From enrollment until end of treatment, up to 12 weeks
|
0.00%
0/13 • From enrollment until end of treatment, up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place