[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584181":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":42,"locations":52,"responsibleParty":91,"collaborators":93,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":12,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":122,"whyStopped":12,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"High Dose","EXPERIMENTAL","High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (38 participants) administered 24hrs prior to first ACT session",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Low Dose","ACTIVE_COMPARATOR","Low Dose (5mg) PEX010 (Oral Psilocybin), 5mg; single dose (20 participants) administered 24hrs prior to first ACT session",[18],"Drug: Psilocybin",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Psilocybin","See treatment arm description.",[14],[26,30,33,36,39],{"name":27,"affiliation":28,"role":29},"Sandy Shultz, PhD","The Institute on Aging & Lifelong Health, Faculty of Health, University of Victoria","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Leah Mayo, PhD","Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine",{"name":34,"affiliation":35,"role":29},"Pamela Kryskow, MD, CCFP","Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society",{"name":37,"affiliation":38,"role":29},"Zachary Walsh, PhD","Professor, Department of Psychology, University of British Columbia",{"name":40,"affiliation":41,"role":29},"Paul van Donkelaar, PhD","Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":12,"email":47},"Chantel T Debert, MD MSc FRCPC","CONTACT","403) 944-4500","cdebert@ucalgary.ca",{"name":49,"role":45,"phone":50,"phoneExt":12,"email":51},"Christina Campbell, MSc","403-944-8649","christina.campbel1@ucalgary.ca",[53,74],{"facility":5,"status":12,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Calgary","Alberta","T2N 2T9","Canada","CA",{"type":60,"coordinates":61},"Point",[62,63],-114.08529,51.05011,{"lat":63,"lon":62},[66,69,71,72],{"name":67,"role":45,"phone":68,"phoneExt":12,"email":47},"Chantel T Debert","(403) 944-4500",{"name":70,"role":45,"phone":50,"phoneExt":12,"email":51},"Christina Campbell",{"name":67,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":73,"role":29,"phone":12,"phoneExt":12,"email":12},"Leah Mayo",{"facility":75,"status":12,"city":76,"state":77,"zip":78,"country":57,"countryCode":58,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"The University of British Columbia - Okanagan Campus","Kelowna","British Columbia","V1V 1V7",{"type":60,"coordinates":80},[81,82],-119.48568,49.88307,{"lat":82,"lon":81},[85,88,89],{"name":86,"role":45,"phone":12,"phoneExt":12,"email":87},"Zachary Walsh","zachary.walsh@ubc.ca",{"name":86,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":90,"role":29,"phone":12,"phoneExt":12,"email":12},"Paul van Donkelaar",{"type":92,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[94,97],{"name":95,"class":96},"Vancouver Island University","UNKNOWN",{"name":98,"class":6},"University of British Columbia","100584181","phase-2-psilocybin-assisted-therapy-for-post-traumatic-stress-disorder-in-survivors-of-intimate-partner-violence-100584181",false,"NCT06885996","Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence","PsiPTSD","Inclusion Criteria:\n\n* Individuals of all sexes, gender identities, and ethnicities\n* Ages 19 to 65 years at the time of screening\n* At least 6 months since last IPV incident\n* A score of 1 on the Composite Abuse Scale with repetition of abusive events\n* Minimum PCL-5 score of ≥ 33\n* Limited lifetime use of serotonergic hallucinogens\n* Ability to read\u002Fwrite English\n\nExclusion Criteria:\n\n* Severe or moderate substance use disorder other than nicotine in past 6 months\n* Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative)\n* Active suicidal ideation or serious attempt within the past 1 year.\n* Current pregnancy or nursing, trying to become pregnant\n* Any notable abnormality on ECG or routine medical blood laboratory test\n* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Epilepsy with a history of seizures\n* Current or recent (within 12 weeks) participation in a clinical trial\n* Cognitive impairment (SLUMS score \\\u003C20)\n* Suffered a moderate\u002Fsevere TBI at least once in lifetime\n* Suffered a mild TBI within the last 6 months\n* Any other circumstances that, in the opinion of the investigators, compromises participant safety\n* Not compelled to enter treatment to avoid legal consequences","ALL","18 Years","65 Years",{"count":110,"type":111},76,"ESTIMATED","INTERVENTIONAL",[114],"PHASE2","The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV).\n\nThis trail will test the following 2 aims:\n\nAIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD.\n\nAIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility.\n\nParticipants will be asked to:\n\n* Complete a 2 part screening process\n* Attend a baseline assessment\n* Complete a psychoeducation preparation session(s)\n* Attend psilocybin administration session (receive high dose \\[25mg\\] or low dose psilocybin \\[1mg\\])\n* Complete 5-6 weekly sessions of ACT\n* Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.",[117,118],"Post Traumatic Stress Disorder PTSD","Intimate Partner Violence (IPV)",[120,22,121],"Psychotherapy","Acceptance and Commitment Therapy","NOT_YET_RECRUITING","2026-05-11",{"date":125,"type":126},"2026-05-14","ACTUAL",{"date":128,"type":111},"2026-08-01",{"date":130,"type":111},"2029-08-01",{"name":5,"class":6},2]