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Recruiting NCT06310187

Little Cigar Oxidants

No phase Interventional Tobacco Use Oxidative Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Oxidant Little Cigar, Low Oxidant Little Cigar, Usual Cigarette.
Who it may be relevant to
Registry conditions: Tobacco Use, Oxidative Stress. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars

Overview

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

  • Other High 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.
  • Other Low 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.
  • Other Usual Cigarette
    Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.

Primary outcome measures

  • 8-isoprostanes Concentration in Exhaled Breath Condensate [Time frame: -5 minutes]
  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate [Time frame: -5 minutes]
  • C-reactive Protein Concentration in Exhaled Breath Condensate [Time frame: -5 minutes]
  • 8-isoprostanes Concentration in Exhaled Breath Condensate [Time frame: 0 minutes]
  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate [Time frame: 0 minutes]
  • C-reactive Protein Concentration in Exhaled Breath Condensate [Time frame: 0 minutes]
  • 8-isoprostanes Concentration in Exhaled Breath Condensate [Time frame: 30 minutes]
  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate [Time frame: 30 minutes]
  • C-reactive Protein Concentration in Exhaled Breath Condensate [Time frame: 30 minutes]
  • 8-isoprostanes Concentration in Exhaled Breath Condensate [Time frame: 60 minutes]

Eligibility criteria

Inclusion criteria

  • 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
  • All other forms of nicotine must be used <6 days out of the past 30 days.
  • Able to read and write in English
  • No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days
  • No plan to quitting smoking in the next 3 months

Exclusion criteria

  • 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
  • Exhaled Carbon Monoxide (CO) measurement of >= 17 parts per million

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Penn State College of Medicine — Hershey

Identifiers

NCT: NCT06310187 · STUDY000023967 · U54DA058271-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗