protocolSection identificationModule nctId: NCT06334016, orgStudyIdInfo id: I-3597023, secondaryIdInfos id: NCI-2024-01556, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3597023, type: OTHER, domain: Roswell Park Cancer Institute, secondaryIdInfos id: R01DA057228, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA057228, briefTitle: Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03-27, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety., conditionsModule conditions: Cannabis Dependence, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Within-subject crossover study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: Both participants and clinical personnel will be blinded to the nicotine product sequence (active vs. placebo)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Cannabis sativa Extract, interventions name: Nicotine, interventions name: Placebo Administration, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Maximum concentration of THC in plasma (Cmax), primaryOutcomes measure: Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360), primaryOutcomes measure: Time to maximum concentration of THC in plasma (Tmax), secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Puffing behaviors, secondaryOutcomes measure: Puffing behaviors, secondaryOutcomes measure: Short-term drug effects, secondaryOutcomes measure: Marijuana Withdrawal Checklist [MWC), secondaryOutcomes measure: Digit Symbol Substitution Task (DSST), secondaryOutcomes measure: Paced Auditory Serial Addition Task (PASET), secondaryOutcomes measure: Tobacco Craving Questionnaire (Short Form), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Danielle M. Smith, role: CONTACT, phone: 716-845-8403, email: Danielle.Smith@RoswellPark.org, contacts name: Danielle M. Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False