nctId: NCT06310187 id: STUDY00023967 id: U54DA058271-01 type: NIH link: https://reporter.nih.gov/quickSearch/U54DA058271-01 briefTitle: Little Cigar Oxidants overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2029-08 date: 2029-08 date: 2024-03-15 date: 2024-03-15 name: Milton S. Hershey Medical Center class: OTHER name: National Institute on Drug Abuse (NIDA) 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). conditions: Tobacco Use conditions: Oxidative Stress studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 50 type: ESTIMATED name: High Oxidant Unflavored Little Cigar - Group A name: Low Oxidant Unflavored Little Cigar - Group B name: High Oxidant Flavored Little Cigar - Group C name: Low Oxidant Flavored Little Cigar - Group D name: Usual Cigarette - Group E name: Unlit Little Cigar - Group F measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate measure: 8-isoprostanes Concentration in Exhaled Breath Condensate measure: 8-isoprostanes Concentration in Exhaled Breath Condensate measure: 8-isoprostanes Concentration in Exhaled Breath Condensate measure: 8-isoprostanes Concentration in Exhaled Breath Condensate measure: C-reactive Protein Concentration in Exhaled Breath Condensate measure: C-reactive Protein Concentration in Exhaled Breath Condensate measure: C-reactive Protein Concentration in Exhaled Breath Condensate measure: C-reactive Protein Concentration in Exhaled Breath Condensate measure: Nicotine Concentration in Exhaled Breath Condensate measure: Nicotine Concentration in Exhaled Breath Condensate measure: Nicotine Concentration in Exhaled Breath Condensate measure: Nicotine Concentration in Exhaled Breath Condensate measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False