[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523721":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":39,"locations":51,"responsibleParty":77,"collaborators":49,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":49,"studyType":94,"phases":95,"briefSummary":98,"conditions":99,"keywords":49,"overallStatus":54,"whyStopped":49,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14,17,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"CBD:THC Group 1","EXPERIMENTAL","Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).\n\nGroup will attend a total of five study visits (one for each study product) with at least 1 week between each visit.\n\nThe order in which the study products will be administered depend on the randomization sequence.",[13],"Drug: ∆9-tetrahydrocannabinol",{"label":15,"type":10,"description":11,"interventionNames":16},"CBD:THC Group 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"CBD:THC Group 3",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"CBD:THC Group 4",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"CBD:THC Group 5",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","∆9-tetrahydrocannabinol","Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled",[9,15,18,21,24],[33],"Cannabidiol",[35],{"name":36,"affiliation":37,"role":38},"Didier Jutras-Aswad, MD, MS","CRCHUM","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Pamela Lachance, PhD","CONTACT","514-890-8000","30938","pamela.lachance-touchette.chum@ssss.gouv.qc.ca",{"name":47,"role":42,"phone":48,"phoneExt":49,"email":50},"François-Olivier Hébert, PhD","581 741-4941",null,"francois-olivier.hebert.chum@ssss.gouv.qc.ca",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Centre de recherche du Centre Hospitalier Universitaire de Montréal","RECRUITING","Montreal","Quebec","H2X0A9","Canada","CA",{"type":61,"coordinates":62},"Point",[63,64],-73.58781,45.50884,{"lat":64,"lon":63},[67,70,75],{"name":68,"role":42,"phone":69,"phoneExt":49,"email":45},"Pamela Lachance-Touchette, Ph.D","514 995 5338",{"name":71,"role":42,"phone":72,"phoneExt":73,"email":74},"Amina Sow, Ph.D","514 890 8000","21491","amina.sow.chum@ssss.gouv.qc.ca",{"name":76,"role":38,"phone":49,"phoneExt":49,"email":49},"Didier Jutras-Aswad, MD",{"type":78,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100523721","phase-1-modulation-of-thc-effects-by-cbd-a-dose-ranging-study-100523721",false,"NCT06099379","Modulation of THC Effects by CBD: a Dose-ranging Study","Modulation of ∆9-tetrahydrocannabinol Acute Psychoactive Effects by Ranging Doses of Cannabidiol in Healthy, Occasional Cannabis Users: a Controlled, Triple Blind, Randomized, Cross-over Study","SPECTRE","Inclusion Criteria:\n\n1. Between 21 and 49 years of age, inclusively;\n2. Have used cannabis at least once in their lifetime and have used cannabis three days or less in the 30 days prior to enrollment;\n3. Be able to provide a signed informed consent;\n4. Willing to comply with study procedures and requirements as per protocol;\n5. Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;\n6. Able to communicate and understand English or French language;\n7. For female participants:\n\n   a. No childbearing potential, defined as: i. postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age); or ii. Documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or b. For female of childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits.\n\nii. AND have no pregnancy plan while on the study iii. AND must agree to use a medically accepted method of birth control throughout the study.\n\nExclusion criteria\n\nParticipants will be excluded if any of the following criteria are met:\n\n1. Any disabling medical condition, as assessed by medical history, physical exam, vital signs and\u002For laboratory assessments that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent;\n2. Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality based on the Mini International Neuropsychiatric Interview);\n3. Any other disabling, unstable or acute mental condition that, in the opinion of the study physician, precludes safe participation in the study or ability to provide fully informed consent;\n4. Known chronic liver disease or aspartate transaminase\u002Falanine transaminase (AST\u002FALT) two times higher than upper limit of normal values at screening visit;\n5. Blood pressure higher than 130\u002F80 mmHg;\n6. Kidney disorders;\n7. Bleeding disorders;\n8. Current moderate or severe DSM-5 substance use disorder (except nicotine) according to SCID-V;\n9. Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;\n10. Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;\n11. Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with cannabis.\n12. Participation in clinical studies or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization.\n13. Resting heart rate over 100 beats per minute.\n14. Current body mass index (BMI) over 29.9 kg\u002Fm2.\n15. Any clinically significant electrocardiogram abnormalities at screening visit.",true,"ALL","21 Years","49 Years",{"count":92,"type":93},100,"ESTIMATED","INTERVENTIONAL",[96,97],"PHASE1","PHASE2","The purposes of this study are 1) to determine if CBD modulates THC-induced acute psychoactive effects at different CBD:THC ratios, compared with the control product (0:20, 20:20, 40:20, 80:20, 120:20) and 2) to determine if different doses of CBD modulate other THC induced behavioral effects, compared with the control product and 3)To explore qualitatively whether CBD modulates THC effects by mechanisms that are not detected with standard clinical research tools.",[100,101],"Cannabis","THC","2025-12-16",{"date":104,"type":105},"2025-12-22","ACTUAL",{"date":107,"type":105},"2024-06-27",{"date":109,"type":93},"2026-12-31",{"name":5,"class":6},1]