RecruitingNot Applicable

Little Cigar Oxidants

United States50 participantsStarted 2026-03-23

Plain-language 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.

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

8-isoprostanes Concentration in Exhaled Breath Condensate

Timeframe: -5 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Timeframe: -5 minutes

C-reactive Protein Concentration in Exhaled Breath Condensate

Timeframe: -5 minutes

8-isoprostanes Concentration in Exhaled Breath Condensate

Timeframe: 0 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Timeframe: 0 minutes

C-reactive Protein Concentration in Exhaled Breath Condensate

Timeframe: 0 minutes

8-isoprostanes Concentration in Exhaled Breath Condensate

Timeframe: 30 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Timeframe: 30 minutes

Trial details

NCT IDNCT06310187

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-08

Contact for this trial

Joshua Muscat, Ph.D.

7175318521 jmuscat@pennstatehealth.psu.edu

View on ClinicalTrials.gov More Tobacco Use trials

Plain-language summary

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

8-isoprostanes Concentration in Exhaled Breath Condensate

Timeframe: -5 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Timeframe: -5 minutes

C-reactive Protein Concentration in Exhaled Breath Condensate

Timeframe: -5 minutes

8-isoprostanes Concentration in Exhaled Breath Condensate

Timeframe: 0 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Timeframe: 0 minutes

C-reactive Protein Concentration in Exhaled Breath Condensate

Timeframe: 0 minutes

8-isoprostanes Concentration in Exhaled Breath Condensate

Timeframe: 30 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Timeframe: 30 minutes