Little Cigar Oxidants (NCT06310187) | Clinical Trial Compass
RecruitingNot Applicable
Little Cigar Oxidants
United States50 participantsStarted 2026-03-25
Plain-language 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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring oxidative stress and inflammation markers in my breath, blood, saliva, and cheek cells — what do those measurements actually tell researchers about how little cigars affect my body compared to other tobacco products?
2Since this study doesn't appear to involve a treatment but is focused on collecting biological samples from tobacco users, what would I actually be asked to do during the study, and how many visits or sample collections would that involve?
3The trial is measuring nicotine levels alongside oxidative stress markers — does participating in this study involve any changes to my current tobacco use, or would I continue smoking as I normally do?
4Given that this is a research or observational study rather than a treatment trial, would participating here in any way affect my access to standard cessation support or other treatments for tobacco use?
5The study is collecting exhaled breath condensate and buccal cell samples — are there any known risks or discomforts associated with those collection methods, and is there anything about my current health that might make me a poor fit for this kind of study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
8-isoprostanes Concentration in Exhaled Breath Condensate
Timeframe: -5 minutes
2
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Timeframe: -5 minutes
3
C-reactive Protein Concentration in Exhaled Breath Condensate
Timeframe: -5 minutes
4
8-isoprostanes Concentration in Exhaled Breath Condensate
Timeframe: 0 minutes
5
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Timeframe: 0 minutes
6
C-reactive Protein Concentration in Exhaled Breath Condensate
Timeframe: 0 minutes
7
8-isoprostanes Concentration in Exhaled Breath Condensate
. 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
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Timeframe: 30 minutes
9
C-reactive Protein Concentration in Exhaled Breath Condensate
Timeframe: 30 minutes
10
8-isoprostanes Concentration in Exhaled Breath Condensate
Timeframe: 60 minutes
11
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Timeframe: 60 minutes
12
C-reactive Protein Concentration in Exhaled Breath Condensate
Timeframe: 60 minutes
13
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples
Timeframe: -5 minutes
14
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples
Timeframe: 0 minutes
15
Nicotine concentration in Blood Samples
Timeframe: -5 minutes
16
Nicotine concentration in Blood Samples
Timeframe: 0 minutes
17
8-isoprostanes Concentration in Blood Samples
Timeframe: -5 minutes
18
8-isoprostanes Concentration in Blood Samples
Timeframe: 0 minutes
19
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples
Timeframe: -5 minutes
20
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples
Timeframe: 0 minutes
21
8-OHdg Acrolein Adduct Concentration in Saliva Samples
Timeframe: -5 minutes
22
8-OHdg Acrolein Adduct Concentration in Saliva Samples