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Search / Trial NCT06310187

Little Cigar Oxidants

Launched by MILTON S. HERSHEY MEDICAL CENTER · Mar 7, 2024

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial, called "Little Cigar Oxidants," is studying how smoking little cigars affects the body, specifically looking at exposure to harmful substances found in tobacco smoke. The researchers want to compare different types of little cigars—both flavored and unflavored, as well as their usual cigarettes—to see how they affect levels of certain harmful markers in the body that are related to oxidative stress, which can affect health. Participants will be cigarette smokers who are 21 years old or older and smoke at least one cigarette daily. They should also be able to read and write in English and not be planning to quit smoking in the next three months.

If you choose to participate, you will be assigned to smoke different products during the study, and your breath will be tested at various times afterwards to measure the levels of toxins. It's important to know that this study excludes people who are pregnant, have serious medical conditions, or have certain respiratory or kidney diseases. Participation in this trial may help us understand more about the effects of little cigars and contribute to information that could benefit public health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Aged 21 and older
  • 2. Daily cigarette smoker (\>= 1 cigarette per day);
  • 3. Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter
  • 4. Able to read and write in English
  • 5. No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days
  • 6. No plan on quitting smoking in the next 3 months
  • 7. Exhaled Carbon Monoxide (CO) measurement of \<= 16 parts per million at baseline
  • 8. Pulmonary Function of 80%-120% determined via Spirometry
  • 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

About Milton S. Hershey Medical Center

Milton S. Hershey Medical Center, a leading academic medical institution affiliated with Penn State University, is dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the center leverages its expertise in various medical fields to conduct rigorous clinical studies aimed at improving treatment outcomes and enhancing the understanding of complex health conditions. The facility is committed to ethical research practices and fostering collaboration among multidisciplinary teams, ensuring that participants receive the highest standard of care while contributing to the advancement of medical knowledge.

Locations

Patients applied

0 patients applied

Trial Officials

Joshua Muscat, Ph.D.

Principal Investigator

Penn State Hershey College of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported