[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659981":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":56,"studyPopulation":43,"armGroups":57,"interventions":95,"overallOfficials":125,"centralContacts":129,"locations":134,"responsibleParty":149,"collaborators":151,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":43,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":162,"minAge":163,"maxAge":43,"enrollmentInfo":164,"targetDuration":43,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":177,"whyStopped":43,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":43,"otherOutcomes":43},[9,13,17,20,23,27,31,34,37,40],{"measure":10,"description":11,"timeFrame":12},"Driving performance as assessed by standard deviation of lateral position (SDLP)","The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.","Baseline, , 2-, 4-, 6-, 8-hours post dosing.",{"measure":14,"description":15,"timeFrame":16},"Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)","Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).","Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing",{"measure":18,"description":19,"timeFrame":16},"Driving Under the Influence of Drugs (DRUID) application global impairment score","Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).",{"measure":21,"description":22,"timeFrame":16},"Number of Correct Trials on the Digit Symbol Substitution Task (DSST)","Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).",{"measure":24,"description":25,"timeFrame":26},"Driving performance as assessed by global drive score","Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). There is no upper or lower limit to possible scores","Baseline, 2, 4, 6, and 8 hours post-dosing.",{"measure":28,"description":29,"timeFrame":30},"Drug Effect Questionnaire (DEQ) - Feel Drug Effect","The DEQ will be used to obtain subjective ratings of \"feel drug effects\". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none\u002Fextreme designation.","Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.",{"measure":32,"description":33,"timeFrame":30},"Drug Effect Questionnaire (DEQ) - Drug Liking","The DEQ will be used to obtain subjective ratings of \"drug liking\". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none\u002Fextreme designation.",{"measure":35,"description":36,"timeFrame":30},"Drug Effect Questionnaire - Confidence to Drive","The DEQ will be used to obtain subjective ratings of \"confidence to drive\". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none\u002Fextreme designation.",{"measure":38,"description":39,"timeFrame":30},"Heart Rate - Beats per Minute","Beats per minute will be used to assess affects on heart rate.",{"measure":41,"description":42,"timeFrame":30},"Whole Blood Concentrations - THC Concentrations","Blood THC concentrations will be measured to assess changing in blood concentrations following drug administration.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"RANDOMIZED","CROSSOVER","All participants will complete all dose conditions (study arms) in a randomized order","BASIC_SCIENCE",{"masking":50,"maskingDescription":43,"whoMasked":51},"QUADRUPLE",[52,53,54,55],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, or 10mg THC; 0, 10, 50, 100, 300mg CBD). Primary outcomes include performance on cognitive and psychomotor assessments, subjective drug effects, simulated driving performance, and impact on blood pharmacokinetics.",[58,64,70,75,80,85,90],{"label":59,"type":60,"description":61,"interventionNames":62},"0mg THC + 0mg CBD","PLACEBO_COMPARATOR","Participants ingest a brownie containing 0mg THC and 0mg CBD.",[63],"Drug: 0mg THC + 0mg CBD Brownie",{"label":65,"type":66,"description":67,"interventionNames":68},"10mg THC + 0mg CBD","EXPERIMENTAL","Participants ingest a brownie containing 10mg THC and 0mg CBD.",[69],"Drug: 10mg THC + 0mg CBD Brownie",{"label":71,"type":66,"description":72,"interventionNames":73},"10mg THC + 10mg CBD","Participants ingest a brownie containing 10mg THC and 10mg CBD.",[74],"Drug: 10mg THC + 10mg CBD Brownie",{"label":76,"type":66,"description":77,"interventionNames":78},"10mg THC + 50mg CBD","Participants ingest a brownie containing 10mg THC and 50mg CBD.",[79],"Drug: 10mg THC + 50mg CBD Brownie",{"label":81,"type":66,"description":82,"interventionNames":83},"10mg THC + 100mg CBD","Participants ingest a brownie containing 10mg THC and 100mg CBD.",[84],"Drug: 10mg THC + 100mg CBD Brownie",{"label":86,"type":66,"description":87,"interventionNames":88},"10mg THC + 300mg CBD","Participants ingest a brownie containing 10mg THC and 300mg CBD.",[89],"Drug: 10mg THC + 300mg CBD Brownie",{"label":91,"type":66,"description":92,"interventionNames":93},"0mg THC + 300mg CBD","Participants ingest a brownie containing 0mg THC and 300mg CBD.",[94],"Drug: 0mg THC + 300mg CBD Brownie",[96,101,105,109,113,117,121],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":43},"DRUG","0mg THC + 0mg CBD Brownie","Brownie containing no THC and CBD will be self administered through oral ingestion.",[59],{"type":97,"name":102,"description":103,"armGroupLabels":104,"otherNames":43},"10mg THC + 0mg CBD Brownie","Brownie containing 10mg THC and no CBD will be self administered through oral ingestion.",[65],{"type":97,"name":106,"description":107,"armGroupLabels":108,"otherNames":43},"10mg THC + 10mg CBD Brownie","Brownie containing 10mg THC and 10mg CBD will be self administered through oral ingestion.",[71],{"type":97,"name":110,"description":111,"armGroupLabels":112,"otherNames":43},"10mg THC + 50mg CBD Brownie","Brownie containing 10mg THC and 50mg CBD will be self administered through oral ingestion.",[76],{"type":97,"name":114,"description":115,"armGroupLabels":116,"otherNames":43},"10mg THC + 100mg CBD Brownie","Brownie containing 10mg THC and 100mg CBD will be self administered through oral ingestion.",[81],{"type":97,"name":118,"description":119,"armGroupLabels":120,"otherNames":43},"10mg THC + 300mg CBD Brownie","Brownie containing 10mg THC and 300mg CBD will be self administered through oral ingestion.",[86],{"type":97,"name":122,"description":123,"armGroupLabels":124,"otherNames":43},"0mg THC + 300mg CBD Brownie","Brownie containing no THC and 300mg CBD will be self administered through oral ingestion.",[91],[126],{"name":127,"affiliation":5,"role":128},"Carlos A Zamarripa, PhD","PRINCIPAL_INVESTIGATOR",[130],{"name":127,"role":131,"phone":132,"phoneExt":43,"email":133},"CONTACT","410-550-6969","czamarr2@jhmi.edu",[135],{"facility":5,"status":43,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":146,"contacts":147},"Baltimore","Maryland","21224","United States","US",{"type":142,"coordinates":143},"Point",[144,145],-76.61219,39.29038,{"lat":145,"lon":144},[148],{"name":127,"role":131,"phone":132,"phoneExt":43,"email":133},{"type":150,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[152],{"name":153,"class":154},"National Institute on Drug Abuse (NIDA)","NIH","100659981","phase-1-effects-of-cannabidiol-cbd-on-a-fixed-dose-of-delta-9-tetrahydrocannabinol-thc-100659981",false,"NCT07870187","Effects of Cannabidiol (CBD) on a Fixed Dose of Delta-9-tetrahydrocannabinol (THC)","Inclusion Criteria:\n\n* at least 21 years old;\n* be in good general health based on screening procedures (e.g., physical exam, EKG, blood testing, psychiatric evaluation);\n* have vital signs in normal range;\n* have not donated blood in past 30 days;\n* not be pregnant (assessed via blood serum at screening and urinalysis before each study session) or breast feeding (women only);\n* have a body mass index (BMI) in the range of 18 to 36 kg\u002Fm\\^2;\n* report using cannabis in the last 3 years, but not in the past month;\n* negative urine test for illicit drug use (including THC) and negative breath alcohol test (0% breath alcohol concentration) at screening and before study sessions.\n\nExclusion Criteria:\n\n* psychoactive drug use (aside from nicotine, alcohol, or caffeine) in past month;\n* current use of over the counter (OTC) drugs, supplements\u002Fvitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety or pharmacokinetics (PK) of the study drugs;\n* history of or current evidence of significant medical condition;\n* evidence of current psychiatric condition (based on MINI);\n* been in treatment previously for cannabis use disorder;\n* liver function tests more than 2x normal range;\n* enrollment in another clinical trial or receiving of any drug as part of research within past 30 days;\n* epilepsy or a history of seizures",true,"ALL","21 Years",{"count":165,"type":166},70,"ESTIMATED","INTERVENTIONAL",[169],"PHASE1","This study will evaluate the subjective and behavioral effects of cannabis products containing delta-9-tetrahydrocannabinol and cannabidiol",[172],"Cannabis Intoxication",[174,175,176],"Cannabis","delta-9-tetrahydrocannabinol","cannabidiol","NOT_YET_RECRUITING","2026-10-06",{"date":180,"type":181},"2026-10-13","ACTUAL",{"date":183,"type":166},"2027-02-01",{"date":185,"type":166},"2029-02-01",{"name":5,"class":6},1]