Tobacco UseNCT06310187
Little Cigar Oxidants
A study testing High Oxidant Little Cigar, Low Oxidant Little Cigar and Usual Cigarette in people with Tobacco Use and Oxidative Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Tobacco Use, Oxidative Stress
- What is being tested?
- High Oxidant Little Cigar, Low Oxidant Little Cigar and Usual Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Kenneth Houser, MS, 7175315473, khouser@pennstatehealth.psu.edu
Joshua Muscat, PhD
About this study
Official title: Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars
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.
Read the 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.
- Conditions
- Tobacco Use, Oxidative Stress
- Being tested
- High Oxidant Little Cigar, Low Oxidant Little Cigar, Usual Cigarette
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Oxidant Little CigarOther
Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.
Low Oxidant Little CigarOther
Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.
Usual CigaretteOther
Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit. Receives: Other: High Oxidant Little Cigar; Other: Low Oxidant Little Cigar; Other: Usual Cigarette |
| Group B | Experimental | Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit. Receives: Other: High Oxidant Little Cigar; Other: Low Oxidant Little Cigar; Other: Usual Cigarette |
| Group C | Experimental | Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit. Receives: Other: High Oxidant Little Cigar; Other: Low Oxidant Little Cigar; Other: Usual Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-isoprostanes Concentration in Exhaled Breath Condensate
Measured: -5 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Measured: -5 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
Measured: -5 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate
Measured: 0 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Measured: 0 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
Measured: 0 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate
Measured: 30 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Measured: 30 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
Measured: 30 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate
Measured: 60 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Measured: 60 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
Measured: 60 minutes
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples
Measured: -5 minutes
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples
Measured: 0 minutes
Nicotine concentration in Blood Samples
Measured: -5 minutes
Nicotine concentration in Blood Samples
Measured: 0 minutes
8-isoprostanes Concentration in Blood Samples
Measured: -5 minutes
8-isoprostanes Concentration in Blood Samples
Measured: 0 minutes
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples
Measured: -5 minutes
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples
Measured: 0 minutes
8-OHdg Acrolein Adduct Concentration in Saliva Samples
Measured: -5 minutes
8-OHdg Acrolein Adduct Concentration in Saliva Samples
Measured: 0 minutes
Metabolomic Profiles in Saliva Samples
Measured: -5 minutes
Metabolomic Profiles in Saliva Samples
Measured: 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start25 Mar 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Williams Design for Cross over-trials with a 3-period 3-treatment cross-over design in 36 healthy daily cigarette smokers.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joshua Muscat, Penn State University
- Investigators
- Joshua Muscat, Ph.D., Principal investigator, Penn State Hershey College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310187
- Sponsor's protocol ID
- STUDY000023967
- Other IDs
- U54DA058271-01
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars
- ClinicalTrials.gov ID
- NCT06310187
- Acronym / sponsor ID
- STUDY000023967
- Conditions
- Tobacco Use, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Williams Design for Cross over-trials with a 3-period 3-treatment cross-over design in 36 healthy daily cigarette smokers.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: High Oxidant Little Cigar, Other: Low Oxidant Little Cigar, Other: Usual CigaretteSubjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit. |
| Group B | Experimental | Other: High Oxidant Little Cigar, Other: Low Oxidant Little Cigar, Other: Usual CigaretteSubjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit. |
| Group C | Experimental | Other: High Oxidant Little Cigar, Other: Low Oxidant Little Cigar, Other: Usual CigaretteSubjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Oxidant Little CigarSubjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage. | Other | Group A, Group B, Group C |
| Low Oxidant Little CigarSubjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage. | Other | Group A, Group B, Group C |
| Usual CigaretteSubjects will use their own cigarette for outcome measure data collection in the lab before and after product usage. | Other | Group A, Group B, Group C |
Primary outcome
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
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
Time frame: 60 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
Time frame: 60 minutes
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples
Time frame: -5 minutes
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples
Time frame: 0 minutes
Nicotine concentration in Blood Samples
Time frame: -5 minutes
Nicotine concentration in Blood Samples
Time frame: 0 minutes
8-isoprostanes Concentration in Blood Samples
Time frame: -5 minutes
8-isoprostanes Concentration in Blood Samples
Time frame: 0 minutes
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples
Time frame: -5 minutes
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples
Time frame: 0 minutes
8-OHdg Acrolein Adduct Concentration in Saliva Samples
Time frame: -5 minutes
8-OHdg Acrolein Adduct Concentration in Saliva Samples
Time frame: 0 minutes
Metabolomic Profiles in Saliva Samples
Time frame: -5 minutes
Metabolomic Profiles in Saliva Samples
Time frame: 0 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Muscat, Ph.D. principal investigator
Penn State Hershey College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Oxidant Little Cigar, Low Oxidant Little Cigar and Usual Cigarette in people with Tobacco Use and Oxidative Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Muscat, Ph.D. (7175318521, jmuscat@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
8-isoprostanes Concentration in Exhaled Breath Condensate (time frame: -5 minutes). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.