{"protocolSection":{"identificationModule":{"nctId":"NCT03946111","orgStudyIdInfo":{"id":"2000022480_a"},"secondaryIdInfos":[{"id":"1R01DK114075-01A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1R01DK114075-01A1"}],"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders","officialTitle":"Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity"},"statusModule":{"statusVerifiedDate":"2025-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-08-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-12-05","type":"ACTUAL"},"completionDateStruct":{"date":"2024-12-05","type":"ACTUAL"},"studyFirstSubmitDate":"2019-04-22","studyFirstSubmitQcDate":"2019-05-09","studyFirstPostDateStruct":{"date":"2019-05-10","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-09-22","resultsFirstSubmitQcDate":"2025-11-21","resultsFirstPostDateStruct":{"date":"2025-12-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-12-16","lastUpdatePostDateStruct":{"date":"2026-01-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Yale University","class":"OTHER"},"collaborators":[{"name":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","class":"NIH"}]},"oversightModule":{"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"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.","detailedDescription":"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."},"conditionsModule":{"conditions":["Binge-Eating Disorder","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":3,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Naltrexone/Bupropion","type":"EXPERIMENTAL","interventionNames":["Drug: Naltrexone and Bupropion"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Naltrexone and Bupropion","description":"Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.","armGroupLabels":["Naltrexone/Bupropion"]},{"type":"OTHER","name":"Placebo","description":"Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Binge-Eating Frequency","description":"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.","timeFrame":"From baseline interview at study enrollment to 3 months after the 12-week treatment."},{"measure":"Change in Binge-Eating Frequency","description":"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.","timeFrame":"From post-treatment to the 6-month follow-up"},{"measure":"Change in Binge-Eating Frequency","description":"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.","timeFrame":"From post-treatment to the 12-month follow-up"},{"measure":"Percent Change in Weight","description":"Negative values indicate weight loss and positive values indicate weight gain.","timeFrame":"From baseline interview at study enrollment to 3 months after the 12-week treatment."},{"measure":"Percent Change in Weight","description":"Negative values indicate weight loss and positive values indicate weight gain.","timeFrame":"From post-treatment to the 6-month follow-up"},{"measure":"Percent Change in Weight","description":"Negative values indicate weight loss and positive values indicate weight gain.","timeFrame":"From post-treatment to the 12-month follow-up"}],"secondaryOutcomes":[{"measure":"Binge-Eating Remission","description":"Categorical: zero binges/28 days","timeFrame":"12-weeks"},{"measure":"Binge-Eating Remission","description":"Categorical: zero binges/28 days","timeFrame":"6-month follow-up"},{"measure":"Binge-Eating Remission","description":"Categorical: zero binges/28 days","timeFrame":"12-month follow-up"},{"measure":"Change in Eating-Disorder Psychopathology (Continuous)","description":"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).","timeFrame":"From baseline interview at study enrollment to 3 months after the 12-week treatment."},{"measure":"Change in Eating-Disorder Psychopathology (Continuous)","description":"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).","timeFrame":"From post-treatment to the 6-month follow-up"},{"measure":"Change in Eating-Disorder Psychopathology (Continuous)","description":"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).","timeFrame":"From post-treatment to the 12-month follow-up"},{"measure":"Change in Depressive Symptoms","description":"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).","timeFrame":"From baseline interview at study enrollment to 3 months after the 12-week treatment."},{"measure":"Change in Depressive Symptoms","description":"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).","timeFrame":"From post-treatment to the 6-month follow-up"},{"measure":"Change in Depressive Symptoms","description":"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).","timeFrame":"From post-treatment to the 12-month follow-up"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 18 to 64 years old\n* Meets DSM-5 criteria for binge-eating disorder\n* BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and \\<50\n* Medically cleared as determined by EKG and medical record review\n* Available for the duration of the treatment and follow-up (18 months)\n* Read, comprehend, and write English at a sufficient level to complete study-related materials\n* Able to travel to study location (New Haven, CT) for weekly visits\n\nExclusion Criteria:\n\n* Previous history of problems with LDX or other stimulants\n* Current psychostimulant use or use of any medication for ADHD\n* Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave\n* History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems.\n* History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.\n* Current uncontrolled hypertension\n* Current uncontrolled type I or II diabetes mellitus\n* Current uncontrolled thyroid illness\n* Gallbladder disease\n* Co-occurring severe mental illness requiring hospitalization or intensive treatment\n* Endorses current active suicidal or homicidal ideation with intent or plan\n* History or current alcohol or substance use disorder (smoking is not exclusionary)\n* Predisposition to seizures\n* History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting\n* Currently taking MAOI, SSRI or strong inhibitors of CYP2D6\n* History of allergy or sensitivity to the study medication or stimulant medications\n* Current use of medications contraindicated with the study medications\n* Currently breast feeding or pregnant, or not willing to use reliable form of contraception\n* Currently taking opioid pain medications or drugs\n* Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss\n* Currently participating in another clinical study in which the participant is or will be exposed to an investigational or a non-investigational drug or device\n* Medical status judged by study physician as contraindication","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"64 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Carlos M Grilo, Ph.D.","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Yale Department of Psychiatry","city":"New Haven","state":"Connecticut","zip":"06510","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"FG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"BG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47","spread":"0.0"},{"groupId":"BG001","value":"43","spread":"19.8"},{"groupId":"BG002","value":"44.33","spread":"14.19"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Binge-Eating Frequency","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"episodes per past 28 days","timeFrame":"From baseline interview at study enrollment to 3 months after the 12-week treatment.","groups":[{"id":"OG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"OG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14","spread":"0"},{"groupId":"OG001","value":"-17.00","spread":"18.38"}]}]}]},{"type":"PRIMARY","title":"Change in Binge-Eating Frequency","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"episodes per past 28 days","timeFrame":"From post-treatment to the 6-month follow-up","groups":[{"id":"OG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"OG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"3","spread":"0"}]}]}]},{"type":"PRIMARY","title":"Change in Binge-Eating Frequency","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"episodes per past 28 days","timeFrame":"From post-treatment to the 12-month follow-up","groups":[{"id":"OG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"OG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4","spread":"0"},{"groupId":"OG001","value":"1.50","spread":"2.12"}]}]}]},{"type":"PRIMARY","title":"Percent Change in Weight","description":"Negative values indicate weight loss and positive values indicate weight gain.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent change","timeFrame":"From baseline interview at study enrollment to 3 months after the 12-week treatment.","groups":[{"id":"OG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"OG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.71","spread":"0"},{"groupId":"OG001","value":"-1.73","spread":"11.35"}]}]}]},{"type":"PRIMARY","title":"Percent Change in Weight","description":"Negative values indicate weight loss and positive values indicate weight gain.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent change","timeFrame":"From post-treatment to the 6-month follow-up","groups":[{"id":"OG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"OG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.82","spread":"0.0"},{"groupId":"OG001","value":"5.61","spread":"8.88"}]}]}]},{"type":"PRIMARY","title":"Percent Change in Weight","description":"Negative values indicate weight loss and positive values indicate weight gain.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent change","timeFrame":"From post-treatment to the 12-month follow-up","groups":[{"id":"OG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"OG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive 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placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Binge-Eating Remission","description":"Categorical: zero binges/28 days","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"12-month follow-up","groups":[{"id":"OG000","title":"Naltrexone/Bupropion","description":"Naltrexone and Bupropion: Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication."},{"id":"OG001","title":"Placebo","description":"Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive 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