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Can cutting nicotine in little cigars reduce harm?

NCT ID NCT06630728

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

21 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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Conditions

The condition(s) this trial relates to.

Behavior, Addictive nicotine dependence Smoking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

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