[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07693153":3,"trial-entities:NCT07693153":125,"trial-summary:NCT07693153":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":13,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":47,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":14,"eligibility_criteria":82,"std_ages":93,"locations":96,"central_contacts":113,"overall_officials":121,"references":123,"see_also_links":124},"NCT07693153","2000041536","The Effects of Psilocybin on Social Connectedness","NOT_YET_RECRUITING","2031-12-15","2026-07","2026-07-09","2026-08-31","Yale University","OTHER",true,"The study is a randomized, double-blind, placebo-controlled, expectancy-controlled, mechanistic trial. This study looks to explore whether a single dose of psilocybin (25mg) reduces amygdala reactivity to negative socioemotional stimuli during the Facial Emotion Recognition Task (FERT) compared to a placebo in adults who feel lonely or those with unresolved grief symptoms.","The main purpose of this study is to determine whether psilocybin engages validated neural and behavioral targets associated with social information processing (SIP), specifically, amygdala threat reactivity, dorsal anterior cingulate, and insula activity during social rejection, and whether this early neural \"target engagement\" predicts downstream improvements in loneliness and social connectedness. By establishing these mechanistic links, this research aims to provide a data driven, experimental medicine foundation for developing effective, mechanism-based interventions to reduce loneliness.",[18,19],"Loneliness","Grief",[21],"Social Connectedness","INTERVENTIONAL",[24],"PHASE1",{"count":26,"type":27},51,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Psilocybin","25 mg",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Placebo","Placebo capsule",[35],[39,43],{"measure":40,"description":41,"timeFrame":42},"Loneliness and social connectedness","UCLA Loneliness Scale (UCLA-20)","Baseline (Day -1) and Day +7, Day +30",{"measure":44,"description":45,"timeFrame":46},"fMRI Baseline Assessments","Hypervigilance to Social Threat: Facial Emotion Recognition Task (FERT)","Day -2, Day +7",[48,50,52,55,57,60,62,65,67,70,72,74,76],{"measure":40,"description":49,"timeFrame":42},"Social Connectedness Scale- Revised (SCS-R)",{"measure":40,"description":51,"timeFrame":42},"Watts Connectedness Scale (WCS)",{"measure":40,"description":53,"timeFrame":54},"PROMIS Social Isolation","Baseline (Day -1), Day +7, Day +30",{"measure":40,"description":56,"timeFrame":42},"Berkman-Syme Social Network Index (SNI)",{"measure":40,"description":58,"timeFrame":59},"The Social Network Map","Baseline (Day -1), Day +30",{"measure":40,"description":61,"timeFrame":42},"Multidimensional Scale of Perceived Social Support (MSPSS)",{"measure":63,"description":64,"timeFrame":42},"Unresolved Grief Symptoms","Brief Grief Questionnaire (BGQ)",{"measure":63,"description":66,"timeFrame":42},"PG-13-Revised (PG-13-R)",{"measure":68,"description":69,"timeFrame":42},"Social-Information-Processing (SIP) Targets & Moderators","Adult Rejection Sensitivity Questionnaire (A-RSQ)",{"measure":68,"description":71,"timeFrame":42},"Yamagishi General and Close Relationship Trust Scale",{"measure":68,"description":73,"timeFrame":54},"Experiences in Close Relationships-Revised (ECR-R)",{"measure":68,"description":75,"timeFrame":42},"Interpersonal Reactivity Index (IRI)",{"measure":77,"description":78,"timeFrame":46},"fMRI baseline assessments","Hypersensitivity to Social Rejection: Cyberball (social exclusion)","ALL","21 Years","65 Years",{"inclusion":83,"exclusion":88,"raw_text":92},[84,85,86,87],"Medically healthy","Ability to provide consent","High loneliness defined by the UCLA-3 Loneliness Scale","Willingness to comply with all study procedures and availability for the duration of the study",[89,90,91],"Any unstable medical condition, psychiatric disorder, or circumstance that, in the opinion of the investigator, could compromise participant safety, interfere with study participation, or hinder the participant's ability to comply with study procedures and requirements","Positive pregnancy test or women who are breastfeeding","Any contraindication to MRI such as a pacemaker or metal implants","Inclusion Criteria:\n\n* Medically healthy\n* Ability to provide consent\n* High loneliness defined by the UCLA-3 Loneliness Scale\n* Willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Any unstable medical condition, psychiatric disorder, or circumstance that, in the opinion of the investigator, could compromise participant safety, interfere with study participation, or hinder the participant's ability to comply with study procedures and requirements\n* Positive pregnancy test or women who are breastfeeding\n* Any contraindication to MRI such as a pacemaker or metal implants",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":98,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":110},"Connecticut Mental Health Center","New Haven","Connecticut","06519","United States",[104,108],{"name":105,"role":106,"email":107},"Anahita Bassir Nia, MD","CONTACT","anahita.bassirnia@yale.edu",{"name":105,"role":109},"PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},41.30815,-72.92816,[114,117],{"name":105,"role":106,"phone":115,"phoneExt":116,"email":107},"203-932-5711","1-5342",{"name":118,"role":106,"phone":119,"email":120},"Yalda Farahmand","203-974-7427","yalda.farahmand@yale.edu",[122],{"name":105,"affiliation":12,"role":109},[],[],{"nct_id":4,"conditions":126,"biomarkers":127},[19,18],[],{"nct_id":4,"found":14,"summary":129,"prompt_version":139},{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either psilocybin or a placebo, and neither you nor the researchers will know which you receive. It plans to enroll 51 participants.","completed","Psilocybin for Loneliness and Grief","This study is looking at how a single dose of psilocybin (25mg) affects feelings of loneliness and social connection in adults aged 21 to 65. You might be able to join if you are medically healthy, feel very lonely (based on a specific scale), or have unresolved grief. Researchers want to see if psilocybin can reduce how your brain reacts to negative social situations, and if this leads to better social connectedness. You would either receive psilocybin or a placebo (an inactive capsule). The study is currently unclear on its recruitment status.","Your loneliness and social connectedness will be measured up to Day +30 after treatment.",92,"You would have assessments at baseline (Day -1), Day +7, and Day +30. You would also have fMRI brain scans at Day -2 and Day +7.","Not stated in the trial record.",[31,35],"v2"]