Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone/ Bupropion combination | Experimental | 50 mg naltrexone and 300 mg bupropion per day for 3 months |
|
| Pill placebo | Placebo Comparator | Daily placebo medication for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone and bupropion combination | Drug |
| ||
| Pill Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | Post-treatment (at 3 months) |
| Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | 6 month follow-up (an average of 6 months following treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | BMI is calculated using measured height and weight. | Post-treatment (at 3 months) |
| Body Mass Index (BMI) | BMI is calculated using measured height and weight. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos M Grilo, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33218742 | Derived | Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clin Ther. 2021 Jan;43(1):112-122.e1. doi: 10.1016/j.clinthera.2020.10.010. Epub 2020 Nov 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone/ Bupropion Combination | 50 mg naltrexone and 300 mg bupropion per day for 3 months Naltrexone and bupropion combination |
| FG001 | Pill Placebo | Daily placebo medication for 3 months Pill Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone/ Bupropion Combination | 50 mg naltrexone and 300 mg bupropion per day for 3 months Naltrexone and bupropion combination |
| BG001 | Pill Placebo | Daily placebo medication for 3 months Pill Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | Posted | Mean | Full Range | binge eating days (out of 28) | Post-treatment (at 3 months) |
|
3 months
Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naltrexone/ Bupropion Combination | 50 mg naltrexone and 300 mg bupropion per day for 3 months Naltrexone and bupropion combination |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment | 1 participant discontinued NB because of anxiety; 1 participant discontinued placebo because of anxiety. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Grilo | Yale School of Medicine | 203-785-2792 | carlos.grilo@yale.edu |
Not provided
| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000621664 | Naltrexone-Bupropion combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| 6 month follow-up (an average of 6 months following treatment) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Binge Eating Frequency | Mean | Full Range | binge eating days (out of 28) |
|
| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | Posted | Mean | Full Range | binge eating days (out of 28) | 6 month follow-up (an average of 6 months following treatment) |
|
|
|
| Secondary | Body Mass Index (BMI) | BMI is calculated using measured height and weight. | Posted | Mean | Full Range | kg/m^2 | Post-treatment (at 3 months) |
|
|
|
| Secondary | Body Mass Index (BMI) | BMI is calculated using measured height and weight. | Posted | Mean | Full Range | kg/m^2 | 6 month follow-up (an average of 6 months following treatment) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | Pill Placebo | Daily placebo medication for 3 months Pill Placebo | 0 | 8 | 0 | 8 | 5 | 8 |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | 1 participant discontinued NB because of vomiting; 0 participants discontinued placebo because of vomiting. |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Hot Flush | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Common Cold | General disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Sinusitis | General disorders | Systematic Assessment |
|
| Sexual Dysfunction | General disorders | Systematic Assessment |
|
| Depression | General disorders | Systematic Assessment |
|
Not provided
Not provided