Little Cigars for Tobacco Use
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how little cigars, both high and low in oxidants, affect exposure to chemicals from tobacco smoke in cigarette smokers. Participants will try both types of little cigars and their usual cigarettes during different visits to observe the effects on their bodies. It is suitable for daily cigarette smokers who have not used little cigars before and do not plan to quit smoking soon. As an unphased trial, this study provides a unique opportunity to contribute to understanding tobacco exposure without the constraints of traditional trial phases.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that little cigars, regardless of their oxidant levels, release more harmful substances called free radicals than regular cigarettes. Free radicals are unstable molecules that can damage cells and tissues in the body. Evidence indicates that smoke from little cigars contains higher levels of toxic and cancer-causing chemicals compared to cigarette smoke, suggesting potential health risks.
Currently, specific health effects of high and low oxidant little cigars remain largely unknown. However, using these products might pose risks equal to or greater than those of smoking regular cigarettes. Many people believe little cigars are less harmful, but research does not necessarily support this belief. Prospective clinical trial participants should consider these factors carefully.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it examines the effects of different types of little cigars and usual cigarettes, specifically focusing on their oxidant levels. Unlike the standard care of smoke cessation products like nicotine patches or gums, this trial uniquely looks at how varying oxidant levels in little cigars might impact users. By comparing high oxidant and low oxidant little cigars with usual cigarettes, researchers hope to uncover insights into health impacts and potentially inform safer smoking alternatives.
What evidence suggests that this trial's treatments could be effective for tobacco smoke exposure?
Research has shown that little cigars release more harmful particles, called free radicals, than regular cigarettes. Free radicals are unstable molecules that can damage cells and lead to health problems. This trial will evaluate both high and low oxidant little cigars, which produce these harmful particles. Studies also reveal that graphic warnings on little cigars can encourage people to attempt quitting, indicating awareness of health risks. However, many still believe little cigars are less harmful than cigarettes. These findings suggest that little cigars could pose significant health risks, so caution is advised.13456
Who Is on the Research Team?
Joshua Muscat, Ph.D.
Principal Investigator
Penn State Hershey College of Medicine
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are exposed to different types of little cigars and their usual cigarette in a randomized cross-over design
Sample Collection and Analysis
Biological samples are collected and analyzed for oxidant markers before and after product usage
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- High Oxidant Little Cigar
- Low Oxidant Little Cigar
- Usual Cigarette
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit.
Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit.
Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Little Cigars are More Toxic than Cigarettes and Uniquely ...
Despite little being known about the health effects of LCs, these products are perceived as less harmful than cigarettes by young adults. Since ...
Free Radicals in Little Cigar Mainstream Smoke and the ...
Our results show that free radical delivery from little cigars is greater than that from research cigarettes and provide empirical evidence for the harmfulness ...
Graphic Warnings on Little Cigars and Cigarillos Drive Higher ...
“These are the strongest data yet showing that graphic warnings on little cigars and cigarillos can influence real-world quitting behaviors,” ...
Free radicals in little cigar mainstream smoke and the ... - PMC
Therefore, as smoke from little cigars is inhaled into the lungs, users are susceptible to the same adverse health effects as are anticipated ...
5.
tobaccoinduceddiseases.org
tobaccoinduceddiseases.org/Perceptions-of-nicotine-harm-among-adults-who-use-little-cigars-and-cigarillos-A,214722,0,2.htmlPerceptions of nicotine harm among adults who use little ...
Approximately 63.0% of respondents who use LCCs overestimated nicotine harms and 65.7% reported nicotine misperceptions. We found no significant ...
Study Details | NCT06310187 | Little Cigar Oxidants
Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage. Other : Low Oxidant ...
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