Clinical trial NCT06310187: Little Cigar Oxidants
Official title: Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tobacco Use
Oxidative Stress
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Williams Design for Cross over-trials with a 6-period 6-treatment cross-over design in 36 healthy daily cigarette smokers.
Primary purpose: BASIC_SCIENCE

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 6 exposure groups. These include a high oxidant unflavored little cigar exposure condition, a low oxidant unflavored little cigar exposure condition, a high oxidant flavored exposure condition, a low oxidant flavored exposure little cigar exposure condition, their usual cigarette, and a control condition (unlit little cigar). Following the smoking of each product, exhaled breath condensate samples will be collected at baseline, 30, 60 and 120 minutes. Samples will be analyzed for levels of oxidant markers including hydrogen peroxide, 8-isoprostanes, and C-reactive protein, as well as nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN).


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

Primary outcomes:
measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate
timeFrame: 0 minutes
measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate
timeFrame: 30 minutes
measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate
timeFrame: 60 minutes
measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate
timeFrame: 120 minutes
measure: 8-isoprostanes Concentration in Exhaled Breath Condensate
timeFrame: 0 minutes
measure: 8-isoprostanes Concentration in Exhaled Breath Condensate
timeFrame: 30 minutes
measure: 8-isoprostanes Concentration in Exhaled Breath Condensate
timeFrame: 60 minutes
measure: 8-isoprostanes Concentration in Exhaled Breath Condensate
timeFrame: 120 minutes
measure: C-reactive Protein Concentration in Exhaled Breath Condensate
timeFrame: 0 minutes
measure: C-reactive Protein Concentration in Exhaled Breath Condensate
timeFrame: 30 minutes
measure: C-reactive Protein Concentration in Exhaled Breath Condensate
timeFrame: 60 minutes
measure: C-reactive Protein Concentration in Exhaled Breath Condensate
timeFrame: 120 minutes
measure: Nicotine Concentration in Exhaled Breath Condensate
timeFrame: 0 minutes
measure: Nicotine Concentration in Exhaled Breath Condensate
timeFrame: 30 minutes
measure: Nicotine Concentration in Exhaled Breath Condensate
timeFrame: 60 minutes
measure: Nicotine Concentration in Exhaled Breath Condensate
timeFrame: 120 minutes
measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate
timeFrame: 0 minutes
measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate
timeFrame: 30 minutes
measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate
timeFrame: 60 minutes
measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate
timeFrame: 120 minutes
measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate
timeFrame: 0 minutes
measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate
timeFrame: 30 minutes
measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate
timeFrame: 60 minutes
measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Penn State Hershey College of Medicine
name: Joshua Muscat, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: