The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question\[s\] it aims to answer are:
Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars?
Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will
* fill several surveys * provide blood samples * perform breathing tests * complete smoking sessions using either their own cigars or the study cigars.
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
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
Single group
Reduced Nicotine Content Cigars
DrugParticipants will smoke a very low nicotine content filtered little cigar containing 0.50mg nicotine per gram of tobacco
Normal nicotine content cigar
DrugParticipants will smoke a normal nicotine content filtered little cigar containing 5.17mg nicotine per gram of tobacco
Usual brand cigar
DrugParticipants will smoke their usual brand filtered little cigar
Drug self-administration- Puff topography- total puff volume
Derived from puff topography, total puff volume indicates the total amount of smoke inhaled during the smoking session. Units: mL
Forced expiratory volume in 1 second
Spirometry will be completed before and after a 65 min smoking session
Nicotine
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 5 minutes after the smoking session
Nicotine
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 65 minutes after the smoking session
Functional residual capacity
Functional residual capacity will be measured with plethysmography to assess dynamic hyperinflation after the smoking session
Airway resistance (R5)
Impulse oscillometry will be used to measure total airway resistance before and after the smoking session
Airway resistance (R5-R20)
Impulse oscillometry will be used to measure small airway resistance before and after the smoking session
Modified Cigarette Evaluation Scale
The 12-item modified Cigarette Evaluation Scale will provide subjective effects of smoking cigars on a 0-6-point Likert scale from "not at all" to "extremely". There are five subscales including smoking satisfaction, psychological reward, enjoyment of respiratory symptoms, craving reduction, and aversion
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