Can cutting nicotine in little cigars reduce harm?
NCT ID NCT06630728
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether very low nicotine little cigars change how people smoke and affect their lungs compared to regular cigars. About 50 adult little cigar smokers will attend three 4-hour visits at Ohio State University. They will fill surveys, give blood, do breathing tests, and smoke either their own cigars or study cigars. The goal is to see if lower nicotine reduces addiction and toxic exposure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Smokers: 1) self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use will be defined as \>=8 cigars smoked per month based on data showing median cigarillo use is 7.5 times per month and median FLC use is 14 times per month 59. We will attempt to bring in heavier users if feasible during recruitment; or 2) Cigarette smokers (\>=8d/month for at least 3 months) with either (i) co-use of filtered little cigars, cigarillos, little cigars, or small cigars (at least once in their lifetime) or (ii) answering "yes" to the question "If all cigarettes were taken off the market, would you consider switching to filtered little cigars?" * willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions * Willing to bring their own, preferred brand little cigars/ small cigars/ cigarillos/ filtered little cigars to smoke in the lab on the first study visit * capable of and willing to provide written informed consent * read and speak in English. Exclusion Criteria: * Self-reported significant current lung disease (e.g. asthma, COPD, cystic fibrosis, pulmonary fibrosis); exercise-induced asthma, seasonal allergies for which a patient takes inhalers are allowed * History of diagnosis or treatment for lung cancer * Self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes) * History of cardiac event or distress within the past 3 months * Unstable or significant psychiatric conditions (past and stable conditions will be allowed) * Substance use disorders besides nicotine addiction * Regular use of other tobacco products besides cigarettes such as snuff, chewing tobacco, snus, e-cigarettes \>10d per month * Exclusive large or premium cigar users * Use of blunts every time or most of the time * Regular use of cannabis \>10d per month * Planning to quit in next 30 days or currently trying to quit or quit attempt in past 30 days * Pregnant, delivery in past 12 weeks, breastfeeding, or planning to get pregnant * Inability to perform tests or follow instructions during testing
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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