Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2026-02-28
2029-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Group A
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.
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.
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.
Usual Cigarette
Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.
Group B
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.
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.
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.
Usual Cigarette
Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.
Group C
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.
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.
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.
Usual Cigarette
Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.
Interventions
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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.
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.
Usual Cigarette
Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Joshua Muscat
Professor, Department of Public Health Sciences
Principal Investigators
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Joshua Muscat, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Penn State Hershey College of Medicine
Central Contacts
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Other Identifiers
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STUDY000023967
Identifier Type: -
Identifier Source: org_study_id
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