Little cigar exposure and oxidative stress markers in adult smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, balanced crossover exposure study in adult daily cigarette smokers who have not used little cigars previously. Each participant will complete three exposure conditions: a high-oxidant little cigar, a low-oxidant little cigar, and their usual cigarette, with biological samples collected before and after product use. Samples include exhaled breath condensate, exhaled breath, blood, buccal cells, and saliva collected at specified time points (pre-use, immediately post-use, and at 30 and 60 minutes) and analyzed for oxidant markers such as 8-isoprostanes, 8-OHdG, acrolein adducts, CRP, VOC profiles, nicotine, and metabolomic signatures. The crossover design allows within-subject comparisons of short-term oxidative exposure between product conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Women who are pregnant and/or nursing or trying to become pregnant
2. Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)
3. 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
4. Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months
5. Exhaled Carbon Monoxide (CO) measurement of \>= 17 parts per million

Where it's running

• Penn State College of Medicine
  Hershey, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Joshua Muscat, Ph.D. — Penn State Hershey College of Medicine
• Study coordinator: Joshua Muscat, Ph.D.
• Email: jmuscat@pennstatehealth.psu.edu
• Phone: 7175318521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.