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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK112771 | 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 efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.
Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NB Medication | Experimental | Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination |
|
| Placebo | Placebo Comparator | Placebo will be inactive and taken daily in pill form. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination | Drug | NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Binge Eating Frequency | Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment." | Post-treatment (3 months) |
| Percent BMI Change | BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at posttreatment] - [BMI at baseline])/[BMI at baseline]. Negative values indicate loss. | Post-treatment (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Binge Eating Frequency | Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment. | 6 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos M Grilo, PhD | Yale University | Principal Investigator |
| Sherry McKee, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NB Medication | Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication) Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form. |
| FG001 | Placebo | Placebo will be inactive and taken daily in pill form. Placebo: Placebo will be inactive and taken daily in pill form. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NB Medication | Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication) Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form. |
| 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 | Change in Binge Eating Frequency | Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment." | Posted | Mean | Standard Deviation | binge-eating episodes per month | Post-treatment (3 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.
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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 | Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication) Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric 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 | Apr 4, 2022 | Apr 14, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 26, 2021 | Apr 14, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
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| Placebo | Other | Placebo will be inactive and taken daily in pill form. |
|
| Change in Binge Eating Frequency | Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment. | 12 months post-treatment |
| Body Mass Index | BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 6 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss. | 6 months post-treatment |
| Body Mass Index | BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 12 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss. | 12 months post-treatment |
| Placebo |
Placebo will be inactive and taken daily in pill form. Placebo: Placebo will be inactive and taken daily in pill form. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sexual Orientation | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form.
|
|
|
| Primary | Percent BMI Change | BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at posttreatment] - [BMI at baseline])/[BMI at baseline]. Negative values indicate loss. | Posted | Mean | Standard Deviation | percent BMI change | Post-treatment (3 months) |
|
|
|
|
| Secondary | Change in Binge Eating Frequency | Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment. | Posted | Mean | Standard Deviation | binge-eating episodes per month | 6 months post-treatment |
|
|
|
|
| Secondary | Change in Binge Eating Frequency | Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment. | Posted | Mean | Standard Deviation | binge-eating episodes per month | 12 months post-treatment |
|
|
|
|
| Secondary | Body Mass Index | BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 6 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss. | Posted | Mean | Standard Deviation | percent BMI change | 6 months post-treatment |
|
|
|
|
| Secondary | Body Mass Index | BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 12 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss. | Posted | Mean | Standard Deviation | percent BMI change | 12 months post-treatment |
|
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 26 |
| 43 |
| EG001 | Placebo | Placebo will be inactive and taken daily in pill form. Placebo: Placebo will be inactive and taken daily in pill form. | 0 | 46 | 0 | 46 | 26 | 46 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal 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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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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