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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 of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .
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 (specialist treatment) RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Experimental | CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. |
|
| Naltrexone/bupropion (NB) (on-going from acute stage) | Active Comparator | Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) | Behavioral | CBT specialist treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binge Eating Frequency (Continuous) | Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously. | Post-treatment (4 months) |
| Change in Body Mass Index at 4 Months Post-Treatment From Baseline | BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | BMI is calculated using measured height and weight (e.g., percent loss). | 12-Month Follow-up |
| Body Mass Index | BMI is calculated using measured height and weight (e.g., percent loss). |
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 |
This study is part of a larger RCT (NCT03045341). In this study, we randomized participants who were non-responders to acute treatment to receive either CBT or no CBT. They continued the pharmacotherapy from the earlier treatment. Because of this study design, we report results based on the primary aim of the study (CBT vs no CBT). Also because of this study design, we report adverse events that were systematically assessed as potentially related to the pharmacotherapy (not to CBT).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. Cognitive-Behavioral Therapy (CBT): CBT specialist treatment NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo) |
| FG001 | On-going Blinded Pharmacotherapy | Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy | CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. Cognitive-Behavioral Therapy (CBT): CBT specialist treatment NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo) |
| 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 assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously. | Posted | Mean | Standard Deviation | Eating events/28 days | Post-treatment (4 months) |
|
Month 1
Participants were interviewed for nonserious adverse events listed as >5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.
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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 | On-going Blinded Pharmacotherapy (NB) | On-going from acute treatment, consisting of naltrexone/bupropion combination |
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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 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 |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| NB Medication (on-going from acute treatment) | Drug | Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or 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 |
| 6-Month Follow-up |
| BG001 | On-going Blinded Pharmacotherapy | Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | On-going Blinded Pharmacotherapy | Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo) |
|
|
|
| Primary | Change in Body Mass Index at 4 Months Post-Treatment From Baseline | BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline | Posted | Mean | Standard Deviation | Kg/m^2 | 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). | No participants in the on-going blinded pharmacotherapy group completed the 12-month follow-up assessment. | Posted | Mean | Standard Deviation | eating events/28 days | 12-Month Follow-up |
|
|
|
| Other Pre-specified | Body Mass Index | BMI is calculated using measured height and weight (e.g., percent loss). | There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study. | Posted | 12-Month Follow-up |
|
|
| Other Pre-specified | Body Mass Index | BMI is calculated using measured height and weight (e.g., percent loss). | There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study. | Posted | 6-Month Follow-up |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| EG001 | On-going Blinded Pharmacotherapy (Placebo) | On-going from acute treatment, consisting of placebo | 0 | 16 | 0 | 16 | 5 | 16 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | 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 |
|
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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 |