[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569337":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":38,"locations":44,"responsibleParty":68,"collaborators":71,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":37,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":37,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":47,"whyStopped":37,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Washington State University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: clopidogrel alone","EXPERIMENTAL","Participants will be administered a single oral dose (75 mg) of clopidogrel. Blood and urine will be collected for 24 hours.",[13],"Drug: Clopidogrel",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: chronic hemp (30 mg CBD) + clopidogrel","Participants will self-administer a single low dose of hemp (30 mg CBD) as an oral softgel at home daily for 5 consecutive days. On day 6, participants will return to the research setting, where they will be administered a single low dose of hemp (30 mg CBD) and a single oral dose of clopidogrel (75 mg). Blood will be collected for 72 hours and urine will be collected for 24 hours.",[18,13],"Drug: Cannabidiol in the form of hemp",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm 3: chronic hemp (240 mg CBD) + clopidogrel","Participants will repeat the Arm 2 procedures using a higher dose of hemp (240 mg CBD)",[18,13],[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Cannabidiol in the form of hemp","Cannabidiol (30 mg) in the form of an orally administered hemp oil softgel",[15,20],[30],"CBD",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Clopidogrel","75 mg oral clopidogrel",[9,15,20],[36],"Plavix",null,[39],{"name":40,"role":41,"phone":42,"phoneExt":37,"email":43},"Mary F Paine, RPh, PhD","CONTACT","509-358-7759","mary.paine@wsu.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Washington State University College of Pharmacy and Pharmaceutical Sciences","RECRUITING","Spokane","Washington","99202","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-117.42908,47.65966,{"lat":57,"lon":56},[60,61,63,66],{"name":40,"role":41,"phone":42,"phoneExt":37,"email":43},{"name":40,"role":62,"phone":37,"phoneExt":37,"email":37},"PRINCIPAL_INVESTIGATOR",{"name":64,"role":65,"phone":37,"phoneExt":37,"email":37},"Matthew Layton, MD, PhD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":37,"phoneExt":37,"email":37},"John White, PharmD, PA-C",{"type":62,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Mary Paine","Professor",[72,75],{"name":73,"class":74},"Office of Dietary Supplements (ODS)","NIH",{"name":76,"class":74},"National Center for Complementary and Integrative Health (NCCIH)","100569337","early-phase-1-effects-of-a-hemp-product-on-the-pharmacokinetics-and-pharmacodynamics-of-clopidogrel-100569337",false,"NCT06692933","Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel","Inclusion Criteria:\n\n* 21-64 years old and healthy;\n* Confirmed by genetic test to be a CYP2C19 normal, rapid, or ultra-rapid metabolizer;\n* Not taking any medications (prescription and non-prescription, including clopidogrel) or dietary supplements\u002Fbotanical products known to alter the pharmacokinetics of cannabis and\u002For clopidogrel;\n* Have taken hemp or cannabis (in any form) before and tolerated it well;\n* Willing to abstain from consuming dietary supplements\u002Fbotanical products and citrus juices for the duration of the study;\n* Willing to abstain from cannabis\u002Fmarijuana, hemp, THC- and\u002For CBD-containing products for several weeks;\n* Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of any inpatient day;\n* Willing to abstain from consuming alcoholic beverages for one day prior to any inpatient day;\n* Willing to use a secondary method of birth control that does not include the introduction or discontinuance of hormonal-based birth control (such as abstinence, copper IUD, or condoms), continuing for 1 week after completing the study;\n* Have the ability to and are willing to comply with the requirements of the study;\n* Geographically located within a 40-mile radius of Spokane and have the time to participate and;\n* Can read and speak English\n\nExclusion Criteria:\n\n* Under the age of 21 or over the age of 64;\n* Any major illness;\n* Pregnant or nursing;\n* History of allergy or intolerance to cannabis or clopidogrel;\n* Taking concomitant medications, both prescription and non-prescription (including clopidogrel) or dietary supplements\u002Fbotanical products known to alter the pharmacokinetics of cannabis and\u002For clopidogrel;\n* Never taken cannabis (in any form) before;\n* Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise participant safety or the quality of the data;\n* Currently using or have recently used drugs or other illicit substances for recreational purposes;\n* Have used cannabis\u002Fmarijuana, hemp, THC- and\u002For CBD-containing products within the last 4 weeks;\n* Have an out-of-range clinical laboratory value such that the study physician considers participation in the study a health risk, or;\n* Unable to read and speak English",true,"ALL","21 Years","64 Years",{"count":88,"type":89},24,"ESTIMATED","INTERVENTIONAL",[92],"EARLY_PHASE1","The goal of this clinical trial is to determine how two different doses of cannabidiol (CBD), given as a hemp product, change the blood concentrations of the drug clopidogrel in the body. Results will be used to help design future studies and to assist healthcare providers in informing their patients about the safe use of CBD.",[95],"Interaction",[97,98,99,30,100,101],"CYP2C19","pharmacokinetics","hemp","natural product","clopidogrel","2026-06-02",{"date":104,"type":105},"2026-06-04","ACTUAL",{"date":107,"type":105},"2024-06-20",{"date":109,"type":89},"2027-12-31",{"name":5,"class":6},1]