Actively Recruiting

Phase 4
Age: 21Years - 75Years
All Genders
Healthy Volunteers
NCT06630728

Addiction Potential of Very Low Nicotine Filtered Little Cigars

Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-10-16

50

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Addiction Potential of Very Low Nicotine Filtered Little Cigars

Who Can Participate

Age: 21Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Regular use of filtered little cigars, cigarillos, little cigars, or small cigars for the past 3 months, smoking at least 8 cigars per month; or cigarette smokers (8 or more days per month for at least 3 months) who have used filtered little cigars or similar cigars before or would consider switching to them if cigarettes were unavailable
  • Willing to abstain from all tobacco and nicotine for at least 12 hours before lab sessions
  • Willing to bring their own preferred brand of little cigars or similar products to the first study visit
  • Able and willing to provide written informed consent
  • Able to read and speak English
Not Eligible

You will not qualify if you...

  • Significant current lung disease such as asthma, COPD, cystic fibrosis, or pulmonary fibrosis (exercise-induced asthma and seasonal allergies treated with inhalers are allowed)
  • History of lung cancer diagnosis or treatment
  • Serious or uncontrolled kidney, liver, or metabolic diseases
  • Cardiac event or distress within the past 3 months
  • Unstable or significant psychiatric conditions (stable past conditions allowed)
  • Substance use disorders other than nicotine addiction
  • Regular use of other tobacco products besides cigarettes more than 10 days per month
  • Exclusive use of large or premium cigars
  • Frequent use of blunts (most or every time)
  • Regular cannabis use more than 10 days per month
  • Planning to quit smoking in the next 30 days, currently trying to quit, or quit attempt in the past 30 days
  • Pregnant, delivered in the past 12 weeks, breastfeeding, or planning pregnancy
  • Inability to perform tests or follow instructions during testing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

D

Dharini M Bhammar, PhD, MBBS

CONTACT

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Addiction Potential of Very Low Nicotine Filtered Little Cigars | DecenTrialz