[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485559":3},{"organization":4,"armGroups":7,"interventions":48,"overallOfficials":61,"centralContacts":65,"locations":74,"responsibleParty":91,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":60,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":60,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":60,"overallStatus":77,"whyStopped":60,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14,20,24,28,32,36,40,44],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Gummy","PLACEBO_COMPARATOR","Participants will self-administer a gummy containing 0mg THC",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Low Dose Gummy","EXPERIMENTAL","Participants will self-administer a gummy containing 10mg THC",[19],"Drug: Cannabis",{"label":21,"type":16,"description":22,"interventionNames":23},"High Dose Gummy","Participants will self-administer a gummy containing 25mg THC",[19],{"label":25,"type":10,"description":26,"interventionNames":27},"Placebo Chocolate","Participants will self-administer chocolate containing 0mg THC",[13],{"label":29,"type":16,"description":30,"interventionNames":31},"Low Dose Chocolate","Participants will self-administer chocolate containing 10mg THC",[19],{"label":33,"type":16,"description":34,"interventionNames":35},"High Dose Chocolate","Participants will self-administer chocolate containing 25mg THC",[19],{"label":37,"type":10,"description":38,"interventionNames":39},"Placebo Beverage","Participants will self-administer a beverage containing 0mg THC",[13],{"label":41,"type":16,"description":42,"interventionNames":43},"Low Dose Beverage","Participants will self-administer a beverage containing 10mg THC",[19],{"label":45,"type":16,"description":46,"interventionNames":47},"High Dose Beverage","Participants will self-administer a beverage containing 25mg THC",[19],[49,56],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Cannabis","Cannabis will be orally ingested",[45,33,21,41,29,15],[55],"marijuana",{"type":50,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Placebo","Placebo will be orally ingested",[37,25,9],null,[62],{"name":63,"affiliation":5,"role":64},"Tory Spindle, PhD","PRINCIPAL_INVESTIGATOR",[66,70],{"name":63,"role":67,"phone":68,"phoneExt":60,"email":69},"CONTACT","410-550-0529","tspindle@jhmi.edu",{"name":71,"role":67,"phone":72,"phoneExt":60,"email":73},"Lindsay Howard","410-550-0009","lhowar29@jhmi.edu",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Johns Hopkins Behavioral Pharmacology Research Unit","RECRUITING","Baltimore","Maryland","21224","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-76.61219,39.29038,{"lat":87,"lon":86},[90],{"name":63,"role":67,"phone":68,"phoneExt":60,"email":69},{"type":92,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR",[94],{"name":95,"class":96},"National Institute on Drug Abuse (NIDA)","NIH","100485559","phase-1-the-impact-of-product-formulation-on-the-pharmacokinetics-and-pharmacodynamics-of-cannabis-edibles-100485559",false,"NCT05602649","The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles","Inclusion Criteria\n\n* Have provided written informed consent.\n* Be between the ages of 21 and 55.\n* Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests).\n* Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions.\n* Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at admission for each session.\n* Have prior experience using THC-dominant cannabis.\n* Have a body mass index (BMI) in the range of 16 to 38 kg\u002Fm2.\n* Have not donated blood in the past 30 days.\n\nExclusion Criteria\n\n* Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days.\n* History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products.\n* Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B.\n* History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the participant's safety or interfere with study outcomes.\n* Evidence of current psychiatric condition (based on MINI for DSM-5).\n* Been in treatment previously for cannabis use disorder.\n* Receiving of any drug as part of a research study within the past 30 days.\n* History of epilepsy or other serious medical condition.",true,"ALL","21 Years","55 Years",{"count":108,"type":109},80,"ESTIMATED","INTERVENTIONAL",[112],"PHASE1","This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session. Participants will consume THC containing products in a fasted state; following drug administration, the participants will complete cognitive and psychomotor tasks, subjective assessments, have blood collected, and vital signs monitored.",[115],"Cannabis Use","2026-04-09",{"date":118,"type":119},"2026-04-13","ACTUAL",{"date":121,"type":119},"2024-07-10",{"date":123,"type":109},"2027-01",{"name":5,"class":6},1]