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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK126637-01 | 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 compare the effectiveness of behavioral and pharmacologic treatments, alone and in combination, for the treatment of loss-of-control eating and weight following bariatric surgery. This is an acute treatment comparing behavioral weight loss alone or in combination with combination naltrexone/bupropion medication.
Participants who provide informed consent and are determined to be eligible will then participate in the study.
A total of 160 patients with obesity and regular LOC-eating following MBS will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. The randomization will be in equal proportions but stratified by surgery type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication | Experimental | Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form. |
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| BWL + Placebo | Experimental | Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form. |
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| NB medication | Experimental | Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone and Bupropion medication | Drug | NB medication will be taken daily in pill form. |
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| Measure | Description | Time Frame |
|---|---|---|
| Loss-of-control Eating Frequency | Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month. | Post-treatment (4 months) |
| Body Mass Index | BMI is calculated using measured height and weight | Post-treatment (4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Loss-of-control Eating Remission | Categorical: zero episodes/28 days | Post-treatment (4 months) |
| Weight loss | Categorical: 5% weight loss |
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Inclusion Criteria:
Be available for participation in the study for up to 19 months (7-month treatment plus 12-month follow up).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Department of Psychiatry | New Haven | Connecticut | 06510 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 9, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Behavioral Weight Loss | Behavioral | Behavioral Weight Loss (BWL) counseling includes weekly sessions. |
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| Placebo | Other | Placebo will be inactive and taken daily in pill form. |
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| Post-treatment (4 months) |
| Eating Disorder Psychopathology | 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). | Post-treatment (4 months) |
| Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms). | Post-treatment (4 months) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |