[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490314":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Arm","PLACEBO_COMPARATOR","Solution without oxytocin",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"TNX-1900","EXPERIMENTAL","Solution with oxytocin",[19],"Drug: TNX-1900 (Tonix Pharmaceuticals)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","TNX-1900 (Tonix Pharmaceuticals)","oxytocin nasal spray",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Nasal solution without oxytocin",[9],[32],{"name":33,"affiliation":5,"role":34},"Elizabeth A Lawson, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Lauren Shabazian, NP","CONTACT","617-726-0047","lshabazian@mgh.harvard.edu",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Jordan Hillard","jhillard1@mgh.harvard.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Neuroendocrine Unit Research Center","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-71.05977,42.35843,{"lat":57,"lon":56},[60,62],{"name":61,"role":38,"phone":26,"phoneExt":26,"email":40},"Lauren Shabazian, MSN",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Elizabeth Austen Lawson","Director, Interdisciplinary Oxytocin Research Program","100490314","phase-2-a-study-of-the-effects-of-oxytocin-in-adults-with-binge-eating-disorder-100490314",false,"NCT05664516","A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder","A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder","STROBE","Inclusion Criteria:\n\n* Males and females, 18-70 years old\n* BMI greater than or equal to 18.5\n* BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) OR Other Specified Feeding or Eating Disorder (OSFED) - Binge-eating disorder (of low frequency and\u002For limited duration) (SCID-5-RV) OR Bulimia Nervosa (BN) through excessive exercise and\u002For fasting to avoid gaining weight after episodes of binge eating. For individuals with OSFED-BED, the frequency of subjective and objective binge eating episodes will meet the frequency (Criterion D) for BED.\n\nExclusion Criteria:\n\n* Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and\u002For laboratory results\n* Medication changes that have not reached steady state concentration, measured by the equivalent of 5 half-lives of that medication\n* Use of medications for binge eating disorder or weight loss unless at a stable dose for at least 12 weeks\n* History of any of the following medical conditions: inflammatory bowel disease or untreated thyroid disease\n* Uncontrolled epilepsy (as defined by a seizure within the last 12 months)\n* Clinically relevant ventricular arrhythmias, coronary heart disease, known long QTc, and hypertrophic cardiomyopathy\n* Hematocrit \\>2% below normal\n* Hemoglobin A1c \\>8%\n* Use of insulin\n* ALT or AST \\>2.5 times upper limit of normal\n* Glomerular filtration rate \\\u003C 60 mL\u002Fmin\n* Hyponatremia. Note that, in order to be randomized, subjects must have Na ≥ 135 mEq\u002FL.\n* Pregnancy or breastfeeding\n* Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)\n* History of psychosis or active suicidal ideation\n* Major depressive disorder likely to require initiation or change in active treatment\n* Borderline personality disorder as assessed by the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD)\n* Current nicotine use, unless stable use for at least 12 weeks.\n* Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization\n* Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or subject safety","ALL","18 Years","70 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This study evaluates the impact of intranasal oxytocin vs placebo in patients with binge eating disorder or episodes of binging. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes \\[reduction in bingeing frequency\\], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention.",[85],"Binge-eating Disorder",[87,88,89,90,91],"Binge","Binge-eating disorder","Oxytocin","Over-eating","Impulse Control","2026-05-26",{"date":94,"type":95},"2026-05-28","ACTUAL",{"date":97,"type":95},"2023-03-07",{"date":99,"type":79},"2026-12",{"name":5,"class":6},1]