protocolSection identificationModule nctId: NCT06303115, orgStudyIdInfo id: CSD231005 BoE, briefTitle: CSD231005 Nicotine Pouch Biomarkers of Exposure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-15, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: RAI Services Company, class: INDUSTRY, descriptionModule briefSummary: This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence., conditionsModule conditions: Tobacco Use, conditions: Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Nicotine Pouch P1312914, 4 mg nicotine, interventions name: Nicotine Pouch P1312915, 8 mg nicotine, interventions name: Nicotine Pouch P1013215, 8 mg nicotine, interventions name: Nicotine Pouch P1013218, 10 mg nicotine, interventions name: Nicotine Pouch P1012919, 12 mg nicotine, interventions name: Smoking Abstinence, interventions name: Continued UB cigarette smoking, outcomesModule primaryOutcomes measure: 4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL], secondaryOutcomes measure: 4Aminobiphenyl [4ABP], secondaryOutcomes measure: 1Aminonaphthalene [1AN], secondaryOutcomes measure: 2Aminonaphthalene [2AN], secondaryOutcomes measure: 2Cyanoethyl mercapturic acid [CEMA], secondaryOutcomes measure: 3Hydroxypropyl mercapturic acid [3HPMA], secondaryOutcomes measure: 3Hydroxy1methylpropylmercapturic acid [HMPMA], secondaryOutcomes measure: 3hydroxybenzo[a]pyrene [3-OH-B[a]P], secondaryOutcomes measure: 1hydroxypyrene [1OHP], secondaryOutcomes measure: Monohydroxybutyl mercapturic acid [MHBMA], secondaryOutcomes measure: Nnitrosonornicotine [NNN] + glucuronides [Total NNN], secondaryOutcomes measure: SPhenyl mercapturic acid [SPMA], secondaryOutcomes measure: Total nicotine equivalents (molar sum of nicotine, cotinine, 3hydroxycotinine and their glucuronides) [TNneq], secondaryOutcomes measure: Carboxyhemoglobin [COHb], secondaryOutcomes measure: Nnitrosonornicotine [NNN] + glucuronides [Total NNN], eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Pillar Bentonville, city: Bentonville, state: Arkansas, zip: 72712, country: United States, geoPoint lat: 36.37285, lon: -94.20882, locations facility: AMR Lexington, city: Lexington, state: Kentucky, zip: 40509, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: QPS Missouri, city: Springfield, state: Missouri, zip: 65802, country: United States, geoPoint lat: 37.21533, lon: -93.29824, locations facility: AMR Knoxville, city: Knoxville, state: Tennessee, zip: 37920, country: United States, contacts name: William Smith, MD, role: CONTACT, geoPoint lat: 35.96064, lon: -83.92074, locations facility: Pillar Richardson, city: Richardson, state: Texas, zip: 75080, country: United States, geoPoint lat: 32.94818, lon: -96.72972, hasResults: False