Effects of Low Nicotine Filtered Little Cigars on Smoking Behavior

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how reducing nicotine content in filtered little cigars influences usage patterns and lung health among current users. Participants will attend three visits at Ohio State University, where they will complete surveys, provide blood samples, perform breathing tests, and smoke either their own cigars or study cigars with varying nicotine levels. The study will assess puffing behaviors, satisfaction, craving suppression, and health effects associated with different nicotine levels in cigars.

Why it matters

Who can join: the full rules

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

Where it's running

• The Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Dharini M Bhammar, PhD, MBBS — Ohio State University
• Study coordinator: Dharini M Bhammar, PhD, MBBS
• Email: dharini.bhammar@osumc.edu
• Phone: 614-366-9467

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.