| NCT ID | NCT06310187 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Tobacco Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-03-23 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Joshua Muscat, Ph.D.
PRINCIPAL INVESTIGATOR
Penn State Hershey College of Medicine
Frequently Asked Questions
Who can join the NCT06310187 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Tobacco Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06310187 currently recruiting?
Yes, NCT06310187 is actively recruiting participants. Contact the research team at jmuscat@pennstatehealth.psu.edu for enrollment information.
Where is the NCT06310187 trial being conducted?
This trial is being conducted at Hershey, United States.
Who is sponsoring the NCT06310187 clinical trial?
NCT06310187 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Joshua Muscat, Ph.D. at Penn State Hershey College of Medicine. The trial plans to enroll 50 participants.