Actively Recruiting
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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how reducing the nicotine content in filtered little cigars affects their use and lung health among adult users. The study aims to compare puffing behaviors, satisfaction, craving suppression, nicotine effects, and exposure to harmful substances between participants' usual cigars, normal nicotine study cigars, and very low nicotine study cigars. This Phase 4 clinical trial is sponsored by Ohio State University Comprehensive Cancer Center and focuses on smoking addiction. Participants will attend three separate smoking sessions, each involving a different cigar type: their own usual brand, a normal nicotine study cigar, and a reduced nicotine content cigar containing 0.50mg nicotine per gram. Each session allows researchers to observe differences in smoking behavior and physical effects. The sessions are designed to last up to 65 minutes of puffing time, with careful monitoring of nicotine intake and other health indicators. During three study visits lasting up to four hours each, participants will complete surveys, provide blood samples, and perform breathing tests to evaluate lung function and toxicant exposure. Researchers will measure outcomes such as puff volume, nicotine levels, carbon monoxide changes, and lung function changes before and after smoking sessions. This comprehensive assessment will help understand how nicotine reduction impacts smoking behavior and health over the course of the study, which is expected to continue until January 2028.
CONDITIONS
Brief Title
Addiction Potential of Very Low Nicotine Filtered Little Cigars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 75 years
- Current regular use of filtered little cigars, cigarillos, little cigars, or small cigars for at least 3 months, defined as 8 or more cigars smoked per month
- Cigarette smokers using tobacco 8 or more days per month for at least 3 months who have used filtered little cigars or would consider switching if cigarettes were unavailable
- Willing to abstain from all tobacco and nicotine for at least 12 hours before lab sessions
- Able and willing to bring their own preferred brand of filtered little cigars or related cigars to the first study visit
- Capable of providing written informed consent
- Able to read and speak English
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 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 (every time or most of the time)
- Regular cannabis use more than 10 days per month
- Planning to quit tobacco in the next 30 days, currently trying to quit, or recent quit attempt within 30 days
- Pregnant, recently delivered within 12 weeks, breastfeeding, or planning pregnancy
- Unable to perform tests or follow instructions during testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Each session lasts approximately 65 minutes
Participants undergo three separate smoking sessions using their usual brand cigar, a normal nicotine content cigar, and a reduced nicotine content cigar.
3 smoking sessions (in-person)
Trial Site Locations
Total: 1 location
1
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
D
Dharini M Bhammar, PhD, MBBS
T
The Ohio State University Comprehensive Cancer Center
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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