NCT06310187

Little Cigar Oxidants

Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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 3 exposure groups. These include a high oxidant little cigar exposure condition, a low oxidant little cigar exposure condition, and their usual cigarette. Biological samples will be collected before and after product usage.

Detailed description

Exhaled breath condensate samples will be collected at pre-product usage, post-product usage, 30, and 60 minutes. Samples will be analyzed for levels of oxidant markers including 8-isoprostanes, 8-OHdG acrolein adducts and C-reactive protein. Exhaled breath samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for levels of oxidant markers in Volitive Organic Compound (VOC) profiles. Blood samples will be collected at pre-product usage and post-product usage. Samples will be analyzed nicotine, 8-isoprostane and other oxidative makers of stress. Buccal cell samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts. Salvia samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts and metabolomic profiles.

Conditions

• Tobacco Use
• Oxidative Stress

Interventions

Type	Name	Description
OTHER	High Oxidant Little Cigar	Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.
OTHER	Low Oxidant Little Cigar	Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.
OTHER	Usual Cigarette	Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.

Timeline

• Start date: 2026-03-23
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2024-03-15
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States