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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK049587 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.
Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NB medication | Experimental | 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. |
|
| Placebo | Placebo Comparator | Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NB medication (Naltrexone Bupropion combination) | Drug | NB medication |
|
| 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 will be defined continuously (analyzed dimensionally). | Post-treatment (4 months) |
| Change in Body Mass Index | BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss. | baseline and Post-treatment (4 months) |
| 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 will be defined continuously (analyzed dimensionally). | 6-Month Follow-up |
| Binge Eating Frequency (Continuous) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos M Grilo, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
The main study (acute treatment results) can be found in NCT03045341. Two participants dropped prior to beginning the medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 will be defined continuously (analyzed dimensionally). | Posted | Mean | Standard Deviation | binge eating days per month | Post-treatment (4 months) |
|
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. For serious adverse events, we provide the total participants [all available data] who reported the adverse event over the course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive Crisis | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Grilo | Yale University | 203 785 7210 | carlos.grilo@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2020 | Nov 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| C000621664 | Naltrexone-Bupropion combination |
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
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| Placebo | Other | Placebo |
|
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). |
| 12-Month Follow-up |
| Change in Body Mass Index (BMI) | BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss. | Baseline to 6-Month Follow-up |
| Change in Body Mass Index | BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss. | Baseline to 12-Month Follow-up |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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|
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| Primary | Change in Body Mass Index | BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss. | Posted | Mean | Standard Deviation | percentage weight change | baseline and Post-treatment (4 months) |
|
|
|
|
| Secondary | Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). | Posted | Mean | Standard Deviation | eating events/28 days | 6-Month Follow-up |
|
|
|
| Secondary | Binge Eating Frequency (Continuous) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). | Posted | Mean | Standard Deviation | eating events/28 days | 12-Month Follow-up |
|
|
|
| Secondary | Change in Body Mass Index (BMI) | BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss. | Posted | Mean | Standard Deviation | percentage change in BMI | Baseline to 6-Month Follow-up |
|
|
|
| Secondary | Change in Body Mass Index | BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss. | Posted | Mean | Standard Deviation | percentage change in BMI | Baseline to 12-Month Follow-up |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 21 |
| 32 |
| EG001 | 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 | 0 | 34 | 0 | 34 | 18 | 34 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |