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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK114075-01A1 | 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 relative efficacy and effectiveness of the combination of naltrexone and bupropion (NB) medication as a treatment for binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, NB medication results in superior outcomes compared with placebo.
Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether Naltrexone/Bupropion medication results in superior and longer-term outcomes than placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone/Bupropion | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone and Bupropion | Drug | Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled. | From baseline interview at study enrollment to 3 months after the 12-week treatment. |
| Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled. | From post-treatment to the 6-month follow-up |
| Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled. | From post-treatment to the 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Binge-Eating Remission | Categorical: zero binges/28 days | 12-weeks |
| Binge-Eating Remission | Categorical: zero binges/28 days | 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos M Grilo, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Department of Psychiatry | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone/Bupropion | Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication. |
| FG001 | Placebo | Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone/Bupropion | Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication. |
| BG001 | Placebo | Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. |
| Units | Counts |
|---|---|
| Participants |
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| 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 frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled. | Posted | Mean | Standard Deviation | episodes per past 28 days | From baseline interview at study enrollment to 3 months after the 12-week treatment. |
|
12 months
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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 | Naltrexone/Bupropion | Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication. |
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| 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 M. Grilo | Yale School of Medicine | 2037857210 | 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 | May 18, 2022 | Sep 18, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2022 | Feb 23, 2024 | ICF_001.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 |
|---|---|
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
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| Placebo | Other | Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. |
|
| Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | From baseline interview at study enrollment to 3 months after the 12-week treatment. |
| Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | From post-treatment to the 6-month follow-up |
| Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | From post-treatment to the 12-month follow-up |
| Binge-Eating Remission | Categorical: zero binges/28 days | 12-month follow-up |
| Change in Eating-Disorder Psychopathology (Continuous) | Eating-disorder psychopathology is 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). | From baseline interview at study enrollment to 3 months after the 12-week treatment. |
| Change in Eating-Disorder Psychopathology (Continuous) | Eating-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). | From post-treatment to the 6-month follow-up |
| Change in Eating-Disorder Psychopathology (Continuous) | Eating-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). | From post-treatment to the 12-month follow-up |
| Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | From baseline interview at study enrollment to 3 months after the 12-week treatment. |
| Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | From post-treatment to the 6-month follow-up |
| Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | From post-treatment to the 12-month follow-up |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. |
|
|
| Primary | Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled. | Posted | Mean | Standard Deviation | episodes per past 28 days | From post-treatment to the 6-month follow-up |
|
|
|
| Primary | Change in Binge-Eating Frequency | Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled. | Posted | Mean | Standard Deviation | episodes per past 28 days | From post-treatment to the 12-month follow-up |
|
|
|
| Primary | Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | Posted | Mean | Standard Deviation | percent change | From baseline interview at study enrollment to 3 months after the 12-week treatment. |
|
|
|
| Primary | Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | Posted | Mean | Standard Deviation | percent change | From post-treatment to the 6-month follow-up |
|
|
|
| Primary | Percent Change in Weight | Negative values indicate weight loss and positive values indicate weight gain. | Posted | Mean | Standard Deviation | percent change | From post-treatment to the 12-month follow-up |
|
|
|
| Secondary | Binge-Eating Remission | Categorical: zero binges/28 days | Posted | Count of Participants | Participants | 12-weeks |
|
|
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| Secondary | Binge-Eating Remission | Categorical: zero binges/28 days | Posted | Count of Participants | Participants | 6-month follow-up |
|
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| Secondary | Binge-Eating Remission | Categorical: zero binges/28 days | Posted | Count of Participants | Participants | 12-month follow-up |
|
|
|
| Secondary | Change in Eating-Disorder Psychopathology (Continuous) | Eating-disorder psychopathology is 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). | Posted | Mean | Standard Deviation | score on a scale | From baseline interview at study enrollment to 3 months after the 12-week treatment. |
|
|
|
| Secondary | Change in Eating-Disorder Psychopathology (Continuous) | Eating-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). | Posted | Mean | Standard Deviation | score on a scale | From post-treatment to the 6-month follow-up |
|
|
|
| Secondary | Change in Eating-Disorder Psychopathology (Continuous) | Eating-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). | Posted | Mean | Standard Deviation | score on a scale | From post-treatment to the 12-month follow-up |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | Posted | Mean | Standard Deviation | score on a scale | From baseline interview at study enrollment to 3 months after the 12-week treatment. |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | Posted | Mean | Standard Deviation | score on a scale | From post-treatment to the 6-month follow-up |
|
|
|
| Secondary | Change in Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms). | Posted | Mean | Standard Deviation | score on a scale | From post-treatment to the 12-month follow-up |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo | Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo. | 0 | 2 | 0 | 2 | 1 | 2 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| 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 |