Little Cigar Oxidants

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06310187
Status
Recruiting
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Conditions

  • Oxidative Stress
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 23, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group A
    Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit.
  • Experimental: Group B
    Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit.
  • Experimental: Group C
    Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit.

Primary Outcome Measure

8-isoprostanes Concentration in Exhaled Breath Condensate [ Time Frame: -5 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State College of MedicineHersheyPennsylvania17033
Kenneth Houser, MS
[email protected]
7175315473
Joshua Muscat, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Penn State College of Medicine· Hershey, PA

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