Addiction Potential of Very Low Nicotine Filtered Little Cigars

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-75
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Reduced Nicotine Content Cigars
  • Normal nicotine content cigar
  • Usual brand cigar

Treatment groups

50 Participants
are divided into 1 treatment group