Oxidative Stress, Tobacco Use
Conditions
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.
Detailed description
Exhaled breath condensate samples will be collected at pre-product usage, post-product usage, 30, and 60 minutes. Samples will be analyzed for levels of oxidant markers including 8-isoprostanes, 8-OHdG acrolein adducts and C-reactive protein. Exhaled breath samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for levels of oxidant markers in Volitive Organic Compound (VOC) profiles. Blood samples will be collected at pre-product usage and post-product usage. Samples will be analyzed nicotine, 8-isoprostane and other oxidative makers of stress. Buccal cell samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts. Salvia samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts and metabolomic profiles.
Interventions
OTHERHigh 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.
OTHERLow 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.
OTHERUsual Cigarette
Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.
Sponsors
Milton S. Hershey Medical Center
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Williams Design for Cross over-trials with a 3-period 3-treatment cross-over design in 36 healthy daily cigarette smokers.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 8-isoprostanes Concentration in Exhaled Breath Condensate | -5 minutes |
| 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate | -5 minutes |
| C-reactive Protein Concentration in Exhaled Breath Condensate | -5 minutes |
| Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples | -5 minutes |
| Nicotine concentration in Blood Samples | -5 minutes |
| 8-isoprostanes Concentration in Blood Samples | -5 minutes |
| 8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples | -5 minutes |
| 8-OHdg Acrolein Adduct Concentration in Saliva Samples | -5 minutes |
| Metabolomic Profiles in Saliva Samples | -5 minutes |
Countries
United States
Contacts
CONTACTJoshua Muscat, Ph.D.
CONTACTKenneth Houser, MS
PRINCIPAL_INVESTIGATORJoshua Muscat, Ph.D.
Penn State Hershey College of Medicine
Outcome results
None listed