Little Cigar Oxidants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorMilton S. Hershey Medical Center
About this trial
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
Qualifiers
Aged 21 - 65 years old
Daily cigarette smoker (>= 1 cigarette per day);
Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter
No current or past use of Little Cigars
Disqualifiers
Women who are pregnant and/or nursing or trying to become pregnant
Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)
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
Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months
Trial design
Treatments tested in this trial
- High Oxidant Little Cigar
- Low Oxidant Little Cigar
- Usual Cigarette
Treatment groups
50 Participants
are divided into 3 treatment groupsSponsors and collaborators
Milton S. Hershey Medical Center
Lead sponsor
Penn State University
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov