[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478383":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":33,"locations":41,"responsibleParty":61,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Children's Mercy Hospital Kansas City","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","All participants will receive both naltrexone and placebo, separated by a washout period, in a randomized, crossover fashion. Those randomized to group A will receive naltrexone then placebo. Those randomized to group B will receive placebo then naltrexone.",[13,14],"Drug: Naltrexone","Drug: Placebo",{"label":16,"type":10,"description":11,"interventionNames":17},"Group B",[13,14],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Naltrexone","Participants will receive a single oral dose in randomized, crossover fashion with a 2 week wash out period between interventions. Medication will be taken 2 hours prior the neuroimaging.",[9,16],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Placebo","Participants will receive a single oral dose of medication in randomized, crossover fashion with a 2 week wash out period between interventions.. Medication will be taken 2 hours prior the neuroimaging.",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Stephani Stancil, PhD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Mariah L Brewe, BA","CONTACT","(816) 916-3409","mbrewe@cmh.edu",{"name":31,"role":36,"phone":24,"phoneExt":24,"email":40},"slstancil@cmh.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Children's Mercy Research Institute","RECRUITING","Kansas City","Missouri","64108","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-94.57857,39.09973,{"lat":54,"lon":53},[57,59],{"name":58,"role":36,"phone":37,"phoneExt":24,"email":38},"Mariah Brewe, BA",{"name":60,"role":32,"phone":24,"phoneExt":24,"email":24},"Stephani L Stancil, PhD, APRN",{"type":32,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Stephani Stancil","Assistant Professor",[65,67],{"name":66,"class":6},"University of Kansas Medical Center",{"name":68,"class":69},"National Institute of Mental Health (NIMH)","NIH","100478383","early-phase-1-naltrexone-neuroimaging-in-teens-with-eating-disorders-100478383",false,"NCT05509257","Naltrexone Neuroimaging in Teens With Eating Disorders","Development of a Pharmacodynamic Biomarker of Opioid Antagonism in Adolescents With Eating Disorders","NN-RCT","Inclusion Criteria:\n\n* Adolescents and young adults aged 13-21 years\n* Eating disorder diagnosis characterized by binge eating and\u002For purging (eg, Anorexia Nervosa-Binge\u002FPurge, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding\u002FEating Disorder) using Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria.\n* Stable medication regimen (no dose or drug changes in the past 4 weeks)\n* Participant and parent\u002Flegal guardian (if under 18 years) are willing and able to provide informed permission\u002Fassent\u002Fconsent for the study\n\nExclusion Criteria:\n\n* Pregnant (via UCG)\n* Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)\n* Non-removable metal in the body that is magnetic resonance imaging incompatible\n* Current naltrexone use\n* Self-reported opioid use in the past 7 days\n* A language barrier (e.g., non-English speaking) for the participant that precludes communication and\u002For ability to complete all study-related requirements.","ALL","13 Years","21 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"EARLY_PHASE1","Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).",[89,90,91,92,93],"Eating Disorders","Binge Eating","Purging (Eating Disorders)","Bulimia Nervosa","Anorexia Nervosa, Atypical",[95,96,97,98,21,99],"Pediatric","Adolescent","Eating Disorder","Neuroimaging","Pharmacodynamic Biomarker","2025-11-20",{"date":102,"type":103},"2025-11-25","ACTUAL",{"date":105,"type":103},"2022-09-17",{"date":107,"type":83},"2027-06",{"name":5,"class":6},1]