protocolSection identificationModule nctId: NCT06310187, orgStudyIdInfo id: STUDY00023967, secondaryIdInfos id: U54DA058271-01, type: NIH, link: https://reporter.nih.gov/quickSearch/U54DA058271-01, briefTitle: Little Cigar Oxidants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2029-08, completionDateStruct date: 2029-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 6 exposure groups. These include a high oxidant unflavored little cigar exposure condition, a low oxidant unflavored little cigar exposure condition, a high oxidant flavored exposure condition, a low oxidant flavored exposure little cigar exposure condition, their usual cigarette, and a control condition (unlit little cigar). Following the smoking of each product, exhaled breath condensate samples will be collected at baseline, 30, 60, 90, 120 and 150 minutes. Samples will be analyzed for levels of oxidant markers including hydrogen peroxide, 8-isoprostanes, and C-reactive protein, as well as nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN)., conditionsModule conditions: Tobacco Use, conditions: Oxidative Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Williams Design for Cross over-trials with a 6-period 6-treatment cross-over design in 36 healthy daily cigarette smokers., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: High Oxidant Unflavored Little Cigar - Group A, interventions name: Low Oxidant Unflavored Little Cigar - Group B, interventions name: High Oxidant Flavored Little Cigar - Group C, interventions name: Low Oxidant Flavored Little Cigar - Group D, interventions name: Usual Cigarette - Group E, interventions name: Unlit Little Cigar - Group F, outcomesModule primaryOutcomes measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 8-isoprostanes Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 8-isoprostanes Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 8-isoprostanes Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 8-isoprostanes Concentration in Exhaled Breath Condensate, primaryOutcomes measure: C-reactive Protein Concentration in Exhaled Breath Condensate, primaryOutcomes measure: C-reactive Protein Concentration in Exhaled Breath Condensate, primaryOutcomes measure: C-reactive Protein Concentration in Exhaled Breath Condensate, primaryOutcomes measure: C-reactive Protein Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Nicotine Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Nicotine Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Nicotine Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Nicotine Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False