Addiction Potential of Very Low Nicotine Filtered Little Cigars

Description

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.

Conditions

Smoking (Tobacco) Addiction

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Study Overview

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Study Details

Study overview

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.

Addiction Potential of Very Low Nicotine Filtered Little Cigars

Addiction Potential of Very Low Nicotine Filtered Little Cigars

Condition
Smoking (Tobacco) Addiction
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 21-55 years old in age
  • * 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
  • * willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
  • * capable of and willing to provide written informed consent
  • * read and speak in English.
  • * 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
  • * Underweight BMI\<18.5 or Extreme obesity BMI \> 50

Ages Eligible for Study

21 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Ohio State University Comprehensive Cancer Center,

Dharini M Bhammar, PhD, MBBS, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

2028-01