RecruitingNot ApplicableNCT06310187

Little Cigar Oxidants

Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars


Sponsor

Milton S. Hershey Medical Center

Enrollment

50 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria8

  • Aged 21 - 65 years old
  • Daily cigarette smoker (>= 1 cigarette per day);
  • Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter
  • No current or past use of Little Cigars
  • All other forms of nicotine must be used <6 days out of the past 30 days.
  • Able to read and write in English
  • No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days
  • No plan to quitting smoking in the next 3 months

Exclusion Criteria5

  • Women who are pregnant and/or nursing or trying to become pregnant
  • Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)
  • Respiratory diseases (e.g., exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data
  • Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months
  • Exhaled Carbon Monoxide (CO) measurement of >= 17 parts per million

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Interventions

OTHERHigh 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.

OTHERLow 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.

OTHERUsual Cigarette

Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.


Locations(1)

Penn State College of Medicine

Hershey, Pennsylvania, United States

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NCT06310187


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