Little cigar exposure and oxidative stress markers in adult smokers

Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars

We will test whether using high- or low-oxidant little cigars changes markers of oxidative stress compared with your usual cigarette in adult daily cigarette smokers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT06310187 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal participants are adults aged 21–65 who smoke at least one cigarette daily, smoke regular filtered cigarettes, have not used little cigars before, and are willing to attend on-site visits in Hershey, PA.

Not a fit: People who are non-smokers, current little cigar users, pregnant or nursing women, or those with recent serious medical or unstable respiratory, cardiac, renal, hepatic, or severe immune conditions are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could clarify whether little cigars produce greater or lesser short-term oxidative exposure than cigarettes and help inform clinical, regulatory, and personal decisions about tobacco product risk.

How similar studies have performed: Biomarker studies of cigarettes have reliably measured acute changes in oxidative markers, but direct comparisons specifically involving little cigars are limited, so this approach is partly established but partly novel for little cigars.

Eligibility criteria

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 this trial is running

Hershey, Pennsylvania

• 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.

Conditions Tobacco Use; Oxidative Stress