Recruiting

Little Cigars

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06310187

Conditions

Tobacco Use

Oxidative Stress

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

High Oxidant Little Cigar

Low Oxidant Little Cigar

Usual Cigarette

Study Details

Brief 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.

Conditions

Tobacco Use

Oxidative Stress

Study ID

NCT06310187

Start date

Mar 25, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Group A

Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit.

experimental: Group B

Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit.

experimental: Group C

Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit.

Interventions

High 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.

Low 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.

Usual Cigarette

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

Primary outcome measure

  • 8-isoprostanes Concentration in Exhaled Breath Condensate [ Time Frame: -5 minutes ]
  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate [ Time Frame: -5 minutes ]
  • C-reactive Protein Concentration in Exhaled Breath Condensate [ Time Frame: -5 minutes ]
  • 8-isoprostanes Concentration in Exhaled Breath Condensate [ Time Frame: 0 minutes ]
  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate [ Time Frame: 0 minutes ]
  • C-reactive Protein Concentration in Exhaled Breath Condensate [ Time Frame: 0 minutes ]
  • 8-isoprostanes Concentration in Exhaled Breath Condensate [ Time Frame: 30 minutes ]
  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate [ Time Frame: 30 minutes ]
  • C-reactive Protein Concentration in Exhaled Breath Condensate [ Time Frame: 30 minutes ]
  • 8-isoprostanes Concentration in Exhaled Breath Condensate [ Time Frame: 60 minutes ]
  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate [ Time Frame: 60 minutes ]
  • C-reactive Protein Concentration in Exhaled Breath Condensate [ Time Frame: 60 minutes ]
  • Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples [ Time Frame: -5 minutes ]
  • Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples [ Time Frame: 0 minutes ]
  • Nicotine concentration in Blood Samples [ Time Frame: -5 minutes ]
  • Nicotine concentration in Blood Samples [ Time Frame: 0 minutes ]
  • 8-isoprostanes Concentration in Blood Samples [ Time Frame: -5 minutes ]
  • 8-isoprostanes Concentration in Blood Samples [ Time Frame: 0 minutes ]
  • 8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples [ Time Frame: -5 minutes ]
  • 8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples [ Time Frame: 0 minutes ]
  • 8-OHdg Acrolein Adduct Concentration in Saliva Samples [ Time Frame: -5 minutes ]
  • 8-OHdg Acrolein Adduct Concentration in Saliva Samples [ Time Frame: 0 minutes ]
  • Metabolomic Profiles in Saliva Samples [ Time Frame: -5 minutes ]
  • Metabolomic Profiles in Saliva Samples [ Time Frame: 0 minutes ]

Central Contacts and Locations

Central contacts

Joshua Muscat, Ph.D.

7175318521jmuscat@pennstatehealth.psu.edu

Kenneth Houser, MS

7175315473khouser@pennstatehealth.psu.edu

Locations

Penn State College of Medicine

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Kenneth Houser, MS

7175315473khouser@pennstatehealth.psu.edu

Principal Investigator:

Joshua Muscat, PhD

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-06-16.