Effects of Low Nicotine Filtered Little Cigars on Smoking Behavior
Addiction Potential of Very Low Nicotine Filtered Little Cigars
PHASE4 · Ohio State University Comprehensive Cancer Center · NCT06630728
This study looks at how smoking little cigars with less nicotine affects how often people smoke and their lung health.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06630728 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how reducing nicotine content in filtered little cigars influences usage patterns and lung health among current users. Participants will attend three visits at Ohio State University, where they will complete surveys, provide blood samples, perform breathing tests, and smoke either their own cigars or study cigars with varying nicotine levels. The study will assess puffing behaviors, satisfaction, craving suppression, and health effects associated with different nicotine levels in cigars.
Who should consider this trial
Good fit: Ideal candidates are adult smokers who regularly use filtered little cigars or are dual-users of cigarettes and little cigars.
Not a fit: Patients with significant current lung disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help inform strategies to reduce smoking addiction and improve lung health among cigar users.
How similar studies have performed: While there is ongoing research into nicotine reduction in cigarettes, this specific approach with filtered little cigars is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Columbus, Ohio
- The Ohio State University — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Dharini M Bhammar, PhD, MBBS — Ohio State University
- Study coordinator: Dharini M Bhammar, PhD, MBBS
- Email: dharini.bhammar@osumc.edu
- Phone: 614-366-9467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Smoking Addiction