RECRUITING

Addiction Potential of Very Low Nicotine Filtered Little Cigars

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Addiction Potential of Very Low Nicotine Filtered Little Cigars

Quick Facts

Study Start:2025-02-13
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06630728

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.

Ages Eligible for Study:21 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 21-55 years old in age
  2. * 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
  3. * willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
  4. * capable of and willing to provide written informed consent
  5. * read and speak in English.
  1. * 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
  2. * History of diagnosis or treatment for lung cancer
  3. * Self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes)
  4. * History of cardiac event or distress within the past 3 months
  5. * Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
  6. * Substance use disorders besides nicotine addiction
  7. * Regular use of other tobacco products besides cigarettes such as snuff, chewing tobacco, snus, e-cigarettes \>10d per month
  8. * Exclusive large or premium cigar users
  9. * Use of blunts every time or most of the time
  10. * Regular use of cannabis \>10d per month
  11. * Planning to quit in next 30 days or currently trying to quit or quit attempt in past 30 days
  12. * Pregnant, delivery in past 12 weeks, breastfeeding, or planning to get pregnant
  13. * Inability to perform tests or follow instructions during testing
  14. * Underweight BMI\<18.5 or Extreme obesity BMI \> 50

Contacts and Locations

Study Contact

Dharini M Bhammar, PhD, MBBS
CONTACT
614-366-9467
dharini.bhammar@osumc.edu
The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Dharini M Bhammar, PhD, MBBS
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-13
Study Completion Date2028-01

Study Record Updates

Study Start Date2025-02-13
Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

  • Smoking (Tobacco) Addiction