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Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

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ClinicalTrials.gov Identifier: NCT02317744
Recruitment Status : Completed
First Posted : December 16, 2014
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Binge Eating Disorder
Interventions Drug: Naltrexone and bupropion combination
Other: Pill Placebo
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone/ Bupropion Combination Pill Placebo
Hide Arm/Group Description

50 mg naltrexone and 300 mg bupropion per day for 3 months

Naltrexone and bupropion combination

Daily placebo medication for 3 months

Pill Placebo

Period Title: Overall Study
Started 12 10
Completed Treatment 10 7
Completed 11 [1] 8 [2]
Not Completed 1 2
[1]
One NB participant stopped the treatment but completed assessments.
[2]
One Placebo participant stopped the treatment but completed assessments.
Arm/Group Title Naltrexone/ Bupropion Combination Pill Placebo Total
Hide Arm/Group Description

50 mg naltrexone and 300 mg bupropion per day for 3 months

Naltrexone and bupropion combination

Daily placebo medication for 3 months

Pill Placebo

Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
10
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 22 participants
51.2  (8.0) 49.4  (10.1) 50.4  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
11
  91.7%
8
  80.0%
19
  86.4%
Male
1
   8.3%
2
  20.0%
3
  13.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 10 participants 22 participants
12
 100.0%
10
 100.0%
22
 100.0%
Binge Eating Frequency  
Mean (Full Range)
Unit of measure:  Binge eating days (out of 28)
Number Analyzed 12 participants 10 participants 22 participants
16.0
(4 to 28)
9.2
(3 to 27)
12.9
(3 to 27)
Body Mass Index (BMI)  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 10 participants 22 participants
35.0
(30 to 49)
40.1
(33 to 48)
37.3
(30 to 49)
1.Primary Outcome
Title Binge Eating Frequency (Continuous)
Hide Description Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Time Frame Post-treatment (at 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone/ Bupropion Combination Pill Placebo
Hide Arm/Group Description:

50 mg naltrexone and 300 mg bupropion per day for 3 months

Naltrexone and bupropion combination

Daily placebo medication for 3 months

Pill Placebo

Overall Number of Participants Analyzed 11 8
Mean (Full Range)
Unit of Measure: binge eating days (out of 28)
4.4
(0 to 28)
3.0
(0 to 16)
2.Primary Outcome
Title Binge Eating Frequency (Continuous)
Hide Description Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Time Frame 6 month follow-up (an average of 6 months following treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone/ Bupropion Combination Pill Placebo
Hide Arm/Group Description:

50 mg naltrexone and 300 mg bupropion per day for 3 months

Naltrexone and bupropion combination

Daily placebo medication for 3 months

Pill Placebo

Overall Number of Participants Analyzed 8 8
Mean (Full Range)
Unit of Measure: binge eating days (out of 28)
5.4
(0 to 25)
2.9
(0 to 14)
3.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description BMI is calculated using measured height and weight.
Time Frame Post-treatment (at 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone/ Bupropion Combination Pill Placebo
Hide Arm/Group Description:

50 mg naltrexone and 300 mg bupropion per day for 3 months

Naltrexone and bupropion combination

Daily placebo medication for 3 months

Pill Placebo

Overall Number of Participants Analyzed 11 9
Mean (Full Range)
Unit of Measure: kg/m^2
34.5
(29 to 48)
39.7
(32 to 47)
4.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description BMI is calculated using measured height and weight.
Time Frame 6 month follow-up (an average of 6 months following treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone/ Bupropion Combination Pill Placebo
Hide Arm/Group Description:

50 mg naltrexone and 300 mg bupropion per day for 3 months

Naltrexone and bupropion combination

Daily placebo medication for 3 months

Pill Placebo

Overall Number of Participants Analyzed 8 8
Mean (Full Range)
Unit of Measure: kg/m^2
35.9
(28 to 48)
40.3
(34 to 45)
Time Frame 3 months
Adverse Event Reporting Description Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
 
Arm/Group Title Naltrexone/ Bupropion Combination Pill Placebo
Hide Arm/Group Description

50 mg naltrexone and 300 mg bupropion per day for 3 months

Naltrexone and bupropion combination

Daily placebo medication for 3 months

Pill Placebo

All-Cause Mortality
Naltrexone/ Bupropion Combination Pill Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone/ Bupropion Combination Pill Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naltrexone/ Bupropion Combination Pill Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/11 (100.00%)   5/8 (62.50%) 
Gastrointestinal disorders     
Vomiting  [1]  3/11 (27.27%)  0/8 (0.00%) 
Constipation   2/11 (18.18%)  1/8 (12.50%) 
Diarrhea   2/11 (18.18%)  2/8 (25.00%) 
Nausea   5/11 (45.45%)  2/8 (25.00%) 
Abdominal Pain   2/11 (18.18%)  1/8 (12.50%) 
General disorders     
Dizziness   5/11 (45.45%)  1/8 (12.50%) 
Dry Mouth   2/11 (18.18%)  2/8 (25.00%) 
Headache   3/11 (27.27%)  4/8 (50.00%) 
Insomnia   5/11 (45.45%)  1/8 (12.50%) 
Hot Flush   4/11 (36.36%)  1/8 (12.50%) 
Fatigue   2/11 (18.18%)  1/8 (12.50%) 
Common Cold   1/11 (9.09%)  0/8 (0.00%) 
Sinusitis   0/11 (0.00%)  1/8 (12.50%) 
Sexual Dysfunction   0/11 (0.00%)  0/8 (0.00%) 
Depression   0/11 (0.00%)  1/8 (12.50%) 
Psychiatric disorders     
Anxiety  [2]  3/11 (27.27%)  5/8 (62.50%) 
Indicates events were collected by systematic assessment
[1]
1 participant discontinued NB because of vomiting; 0 participants discontinued placebo because of vomiting.
[2]
1 participant discontinued NB because of anxiety; 1 participant discontinued placebo because of anxiety.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Carlos Grilo
Organization: Yale School of Medicine
Phone: 203-785-2792
EMail: carlos.grilo@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02317744     History of Changes
Other Study ID Numbers: 1409014705
First Submitted: December 11, 2014
First Posted: December 16, 2014
Results First Submitted: October 13, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017