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NCT Number: NCT06310187

Little Cigar Oxidants

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.

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Key information

Conditions

Tobacco Use Behavior Oxidative Stress

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Location contact

Joshua Muscat, PhD

PRINCIPAL_INVESTIGATOR

Kenneth Houser, MS

CONTACT

[email protected]

7175315473

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 8-isoprostanes Concentration in Exhaled Breath Condensate

    Time frame: -5 minutes

  2. 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

    Time frame: -5 minutes

  3. C-reactive Protein Concentration in Exhaled Breath Condensate

    Time frame: -5 minutes

  4. 8-isoprostanes Concentration in Exhaled Breath Condensate

    Time frame: 0 minutes

  5. 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

    Time frame: 0 minutes

  6. C-reactive Protein Concentration in Exhaled Breath Condensate

    Time frame: 0 minutes

  7. 8-isoprostanes Concentration in Exhaled Breath Condensate

    Time frame: 30 minutes

  8. 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

    Time frame: 30 minutes

  9. C-reactive Protein Concentration in Exhaled Breath Condensate

    Time frame: 30 minutes

  10. 8-isoprostanes Concentration in Exhaled Breath Condensate

    Time frame: 60 minutes

  11. 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

    Time frame: 60 minutes

  12. C-reactive Protein Concentration in Exhaled Breath Condensate

    Time frame: 60 minutes

  13. Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples

    Time frame: -5 minutes

  14. Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples

    Time frame: 0 minutes

  15. Nicotine concentration in Blood Samples

    Time frame: -5 minutes

  16. Nicotine concentration in Blood Samples

    Time frame: 0 minutes

  17. 8-isoprostanes Concentration in Blood Samples

    Time frame: -5 minutes

  18. 8-isoprostanes Concentration in Blood Samples

    Time frame: 0 minutes

  19. 8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples

    Time frame: -5 minutes

  20. 8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples

    Time frame: 0 minutes

  21. 8-OHdg Acrolein Adduct Concentration in Saliva Samples

    Time frame: -5 minutes

  22. 8-OHdg Acrolein Adduct Concentration in Saliva Samples

    Time frame: 0 minutes

  23. Metabolomic Profiles in Saliva Samples

    Time frame: -5 minutes

  24. Metabolomic Profiles in Saliva Samples

    Time frame: 0 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Muscat, Ph.D.

CONTACT

[email protected]

7175318521

Kenneth Houser, MS

CONTACT

[email protected]

7175315473

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 15, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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