[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516043":3},{"organization":4,"armGroups":7,"interventions":45,"overallOfficials":72,"centralContacts":76,"locations":83,"responsibleParty":104,"collaborators":106,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":81,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":139,"overallStatus":86,"whyStopped":81,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,16,20,25,29,33,37,41],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo marijuana and regular cigarette","EXPERIMENTAL","Participants will vape a 50\u002F50 mixture of placebo marijuana (0% THC) and regular cigarette (25.94 mg\u002Fg nicotine content)",[13,14,15],"Drug: Nicotine","Device: Pax Loose Leaf Vaporizer","Other: Placebo Marijuana",{"label":17,"type":10,"description":18,"interventionNames":19},"Placebo marijuana and Very Low Nicotine Content cigarette","Participants will vape a 50\u002F50 mixture of placebo marijuana (0% THC) and Very Low Nicotine Content cigarette (0.42 mg\u002Fg nicotine content)",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Medium marijuana and regular cigarette","Participants will vape a 50\u002F50 mixture of medium marijuana (\\\u003C5% THC) and regular cigarette (25.94 mg\u002Fg nicotine content)",[24,13,14],"Drug: Cannabis",{"label":26,"type":10,"description":27,"interventionNames":28},"Medium marijuana and Very Low Nicotine Content cigarette","Participants will vape a 50\u002F50 mixture of medium marijuana (\\\u003C5% THC) and Very Low Nicotine Content cigarette (0.42 mg\u002Fg nicotine content)",[24,13,14],{"label":30,"type":10,"description":31,"interventionNames":32},"High marijuana and regular cigarette","Participants will vape a 50\u002F50 mixture of high marijuana (\\>10% THC) and regular cigarette (25.94 mg\u002Fg nicotine content)",[24,13,14],{"label":34,"type":10,"description":35,"interventionNames":36},"High marijuana and Very Low Nicotine Content cigarette","Participants will vape a 50\u002F50 mixture of high marijuana (\\>10% THC) and Very Low Nicotine Content cigarette (0.42 mg\u002Fg nicotine content)",[24,13,14],{"label":38,"type":10,"description":39,"interventionNames":40},"High marijuana only","Participants will vape high marijuana (\\>10% THC)",[24,14],{"label":42,"type":10,"description":43,"interventionNames":44},"Regular cigarette only","Participants will vape a regular cigarette (25.94 mg\u002Fg nicotine content)",[13,14],[46,53,59,66],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","Cannabis","Participants will vape marijuana in varying doses from the PAX device",[34,30,38,26,21],[52],"Marijuana",{"type":47,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Nicotine","Participants will vape Regular and Very Low Nicotine content cigarettes from the PAX device",[34,30,26,21,17,9,42],[58],"Nicotine product",{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"DEVICE","Pax Loose Leaf Vaporizer","In all arms, participants will be using the PAX Loose Leave Vaporizer.",[34,30,38,26,21,17,9,42],[65],"Electronic vaporizor",{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Placebo Marijuana","Participants will vape placebo marijuana from the PAX device",[17,9],[71],"Placebo for Marijuana",[73],{"name":74,"affiliation":5,"role":75},"Gideon St Helen","PRINCIPAL_INVESTIGATOR",[77],{"name":78,"role":79,"phone":80,"phoneExt":81,"email":82},"Armando Barraza","CONTACT","628-206-4226",null,"armando.barraza@ucsf.edu",[84],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Zuckerberg San Francisco General Hospital","RECRUITING","San Francisco","California","94110","United States","US",{"type":93,"coordinates":94},"Point",[95,96],-122.41942,37.77493,{"lat":96,"lon":95},[99,102],{"name":100,"role":79,"phone":81,"phoneExt":81,"email":101},"Lisa Lawrence","Lisa.Lawrence@ucsf.edu",{"name":103,"role":75,"phone":81,"phoneExt":81,"email":81},"Gideon St. Helen, PhD",{"type":105,"investigatorFullName":81,"investigatorTitle":81,"investigatorAffiliation":81,"oldNameTitle":81,"oldOrganization":81},"SPONSOR",[107,110,112],{"name":108,"class":109},"National Institute on Drug Abuse (NIDA)","NIH",{"name":111,"class":109},"National Institutes of Health (NIH)",{"name":113,"class":114},"Food and Drug Administration (FDA)","FED","100516043","phase-2-understanding-the-clinical-pharmacology-of-marijuana-tobacco-co-administration-100516043",false,"NCT05999383","Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration","CANNIC","Inclusion Criteria:\n\n* Heart rate \\\u003C 105 beats per minute (BPM)\\*\n* Systolic Blood Pressure \\\u003C 160 and \\> 90\\*\n* Diastolic Blood Pressure \\\u003C 100 and \\> 50\\*\n\n  \\*Considered out of range if both machine and manual readings are above\u002Fbelow these thresholds.\n* Body Mass Index (BMI) ≤ 38.0 (at investigator's discretion for higher BMI if no other concurrent health issues)\n* Current regular user of cannabis who smokes or vapes cannabis or THC extracts at least three days a week for the past 3 months or more\n* Test positive for D-9-tetrahydrocannabinol (THC) at screening and self-report of cannabis use\n* Current user of inhaled forms of tobacco\u002Fnicotine (cigarette, cigars, e-cigarettes) who use the product daily for the past 3 months or more\n* Saliva cotinine ≥ 30 ng\u002FmL\n\nExclusion Criteria:\n\n* Unstable medical conditions:\n\n  * Heart disease\n  * Seizures\n  * Cancer\n  * Thyroid disease (okay if controlled with medication)\n  * Diabetes\n  * Hepatitis B or C or Liver disease\n  * Glaucoma\n  * Kidney disease or urinary retention\n  * An ulcer in the past year\n  * Active use of an inhaler for asthma or Chronic Obstructive Pulmonary Disease (COPD)\n* Hypertension if uncontrolled (meaning participant has a diagnosis, but they are not taking medication\u002Funder treatment (e.g., diet or exercise plan)\n* Drug\u002FAlcohol Dependence\n\n  * Alcohol or illicit drug dependence within the past 12 months (currently in treatment) with the exception of those who recently completed an alcohol\u002Fdrug treatment program\n  * Positive toxicology test at the screening visit (THC \\& prescribed medications okay)\n  * Opioid replacement therapy (including methadone, buprenorphine, or other)\n* Psychiatric conditions\n\n  * Current or past schizophrenia, and\u002For current or past bipolar disorder\n  * Major depression, current or within the past year\n  * Major personality disorder\n  * Participants with current or past minor or moderate depression and\u002For anxiety disorders will be reviewed by the PI \\[study physician\\] and considered for inclusion\n  * History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's \\[study physician's\\] approval\n* Current regular use of any psychiatric medications with the exception of Selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) and current evaluation by the PI that the participant is otherwise healthy, stable, and able to participate\n* Congenital or acquired immunodeficiency disorders (i.e. HIV, congenital immune deficiency syndrome, chronic diseases)\n* Other disorders (i.e. ICU, malnutrition, immunosuppressive therapy)\n* Traumatic brain injury\n* Recent onset or change (worsening) in cough, fever and\u002For abdominal symptoms (vomiting or pain) in the past two weeks\n* Medications\n\n  * Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs)\n  * Concurrent use of nicotine-containing medications\n  * Any stimulant medications (ex. Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment\n* Other\u002FMisc. Chronic Health Problems\n\n  * Oral thrush\n  * Fainting\n  * Other \"life threatening illnesses\" as per study physician's discretion\n* Pregnancy\n\n  * Pregnancy (self-reported and urine pregnancy test)\n  * Breastfeeding (determined by self-report)\n* Concurrent participation in another clinical trial\n* Inability to communicate in English\n* History of marijuana-induced psychosis or paranoia after smoking marijuana\n* Scoring a 7 or higher on the Severity of Dependence Scale (SDS) for cannabis use\n* Planning to quit smoking or vaping within the next 60 days\n* Planning to quit cannabis use within the next 60 days\n* Uncomfortable with getting blood drawn\n* Willingness to abstain from tobacco smoking and all combustible products for 13 hours before admission\n* Willingness to abstain from smoking\u002Fingestion of cannabis 13 hours before\n* Willingness to abstain from nicotine products 13 hours before each admission",true,"ALL","21 Years","65 Years",{"count":127,"type":128},48,"ESTIMATED","INTERVENTIONAL",[131],"PHASE2","This is a crossover, randomized, double-blinded clinical pharmacology study enrolling dual cannabis-tobacco smokers to better understand the combined effects of co-administering cannabis and tobacco. The project aims to describe the pharmacokinetics and pharmacodynamics of marijuana-tobacco co-administration by delivering THC and nicotine in various combinations. This foundational study will establish a research program focused on elucidating the public health consequences of marijuana-tobacco co-use.",[134,48,135,136,137,138],"THC","Cannabis Use","Cannabis Smoking","Tobacco Use","Vaping",[134,48,52,54,140],"Vape","2026-01-05",{"date":143,"type":144},"2026-01-07","ACTUAL",{"date":146,"type":144},"2025-07-01",{"date":148,"type":128},"2028-02-01",{"name":5,"class":6},1]