NCT06630728 · Ohio State University Comprehensive Cancer Center
Addiction Potential of Very Low Nicotine Filtered Little Cigars
(LOWFLC)
What this study 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.
View original scientific 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.
Interventions
DRUG
Reduced Nicotine Content Cigars
Participants will smoke a very low nicotine content filtered little cigar containing 0.50mg nicotine per gram of tobacco
DRUG
Normal nicotine content cigar
Participants will smoke a normal nicotine content filtered little cigar containing 5.17mg nicotine per gram of tobacco
DRUG
Usual brand cigar
Participants will smoke their usual brand filtered little cigar
Primary outcome measures
Drug self-administration- Puff topography- total puff volume
Time frame: During session 65 minute puffing session
Derived from puff topography, total puff volume indicates the total amount of smoke inhaled during the smoking session. Units: mL
Forced expiratory volume in 1 second
Time frame: Change from 0 to 65 minutes
Spirometry will be completed before and after a 65 min smoking session
Nicotine
Time frame: Change from 0 to 5 minutes
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 5 minutes after the smoking session
Nicotine
Time frame: Change from 0 to 65 minutes
Plasma sample will be analyzed for nicotine to assess pharmacokinetics from before to 65 minutes after the smoking session
Carbon monoxide boost
Time frame: Change from 0 to 5 minutes
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and 5 minutes after the smoking session
Carbon monoxide boost
Time frame: Change from 0 to 65 minutes
Exhaled carbon monoxide (CO) will be measured for assessing CO boost as a measure of toxicity before and after the smoking session
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- read and speak in English.
Exclusion criteria
- 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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2025 · Source of record for eligibility and locations