[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619597":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":48,"centralContacts":49,"locations":55,"responsibleParty":74,"collaborators":48,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":48,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":103,"whyStopped":48,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,17,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo","EXPERIMENTAL","3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by \\>1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.",[13,14,15,16],"Drug: AVCN319301b (6mg)","Drug: AVCN319301b (9mg)","Drug: AVCN319301b (15mg)","Drug: Placebo",{"label":18,"type":10,"description":11,"interventionNames":19},"Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg",[13,14,15,16],{"label":21,"type":10,"description":11,"interventionNames":22},"Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg",[13,14,15,16],{"label":24,"type":10,"description":11,"interventionNames":25},"Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg",[13,14,15,16],[27,34,39,44],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","AVCN319301b (6mg)","AVCN319301b is a standardized oral capsule containing a precise dose of Δ9-THC.",[21,9,18,24],[33],"Low Dose",{"type":28,"name":35,"description":30,"armGroupLabels":36,"otherNames":37},"AVCN319301b (9mg)",[21,9,18,24],[38],"Medium Dose",{"type":28,"name":40,"description":30,"armGroupLabels":41,"otherNames":42},"AVCN319301b (15mg)",[21,9,18,24],[43],"High Dose",{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Placebo","The matched placebo is an oral capsule identical in appearance to the active study drug and contains the same non-medicinal ingredients but no Δ9-THC. It is manufactured to match the active capsules in size, color, taste, and packaging to maintain blinding for participants and study staff.",[21,9,18,24],null,[50],{"name":51,"role":52,"phone":53,"phoneExt":48,"email":54},"Leah M Mayo, PhD","CONTACT","587-893-0257","leah.mayo@ucalgary.ca",[56],{"facility":57,"status":48,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"University of Calgary, Heritage Medical Research Building","Calgary","Alberta","T2N 4N1","Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-114.08529,51.05011,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":48,"email":73},"Gavin N Petrie, PhD","5194009323","gavin.petrie@ucalgary.ca",{"type":75,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100619597","phase-1-a-study-testing-the-effects-of-different-thc-doses-on-psychological-and-biological-function-100619597",false,"NCT07346690","A Study Testing the Effects of Different THC Doses on Psychological and Biological Function","Acute Dose-Dependent Effects of Oral THC on Physiological and Subjective Responses in Healthy Cannabis-Experienced Adults","DRATT","Inclusion Criteria:\n\n* Adults aged 18-55\n* No major medical or psychiatric conditions\n* At least one previous, well-tolerated experience with cannabis\n* Not currently pregnant or breastfeeding\n\nExclusion Criteria:\n\n* Family history (first- or second-degree relatives) of bipolar disorder, psychosis, or schizophrenia\n* Significant negative reaction to cannabis in the past or known allergy to cannabis products\n* Currently using recreational drugs",true,"ALL","18 Years","55 Years",{"count":89,"type":90},24,"ESTIMATED","INTERVENTIONAL",[93],"PHASE1","The goal of this clinical trial is to learn how a investigational medicinal product (THC) affects psychological and physical responses in healthy adults with prior cannabis use experience. The main questions it aims to answer are:\n\n\\- How do different dose levels of the investigational medicinal product (THC) influence short-term subjective and physiological responses?\n\nResearchers will compare three dose levels of the study drug to a placebo (a look-alike substance with no active ingredient) to see how responses vary across sessions.\n\nParticipants will:\n\n* Attend four in-person study visits, each involving a single dose of either the study drug or placebo\n* Complete questionnaires about their moment-to-moment experiences\n* Have their heart rate, blood pressure, and other physical measures monitored\n* Undergo serial blood sampling to measure circulating biomarkers",[96,97,98,99],"Evaluate PK Profile","Evaluate PD Profile","Healthy Adults","Safety and Tolerability in Healthy Volunteers",[101,102],"Cannabinoid","Cannabis","NOT_YET_RECRUITING","2026-01-07",{"date":106,"type":107},"2026-01-16","ACTUAL",{"date":109,"type":90},"2026-02-01",{"date":111,"type":90},"2028-02-01",{"name":5,"class":6},1]