Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perception… (NCT06230159) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use
United States34 participantsStarted 2023-11-28
Plain-language summary
This clinical trial evaluates the impact of synthetic cooling agents in combustible cigarettes on smoking perceptions and use. Menthol, a natural chemical, is a cooling agent that increases nicotine dependence among smokers. Menthol cigarettes largely contribute to the huge burden that smoking puts on public health. Approximately 43% of adult smokers smoke menthol cigarettes. Regulatory agencies have begun a ban on menthol. In response to the ban, the tobacco industry has introduced synthetic cooling agents as a flavorless replacement to provide the same cooling effects as menthol. Information gained from this trial may help researchers determine how the addition of synthetic cooling agents changes the appeal, abuse liability potential, and respiratory toxicity profile of combustible cigarettes.
Who can participate
Age range
21 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 21 - 29 years
* Established cigarette user
* Willing to provide informed consent and abstain from using tobacco products 12 hours prior to the three lab sessions
* Read and speak English
Exclusion Criteria:
* Recently coronavirus disease 2019 positive (COVID-19+) or a recent COVID-19 hospitalization
* Self-reported unstable or significant psychiatric conditions
* History of cardiac event or distress within the past 3 months
* Are currently pregnant, planning to become pregnant, or breastfeeding
* Currently attempting to quit using combustible tobacco products
* Have suffered from any serious lung disease or infection in the past 30 days
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at how synthetic cooling agents in cigarettes affect things like appeal and abuse liability — what do those findings mean for someone in my situation who is currently smoking, especially regarding cancer risk?
2The trial measured 'demand' for cigarettes with cooling agents using something called a forced choice task — did the results suggest these types of cigarettes are more or less addictive than standard cigarettes, and does that change any advice you'd give me about quitting?
3Since this study examined puff topography — meaning how deeply and how often people smoked these cigarettes — do the results tell us anything about whether cooling agents cause people to inhale more harmful chemicals, and should that affect what kinds of cigarettes I avoid while I'm trying to quit?
4Now that this trial is completed, are the findings available, and is there anything in the results about cigarette chemical contents that you think I should know about as someone trying to reduce my smoking-related cancer risk?
5Are there currently any evidence-based cessation treatments or other studies you'd recommend I consider instead of, or alongside, learning about this research, given that this was an observational study rather than a treatment trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cigarette Chemical Contents
Timeframe: Approximately 3 months prior to start of participant recruitment
2
Impact of Cooling Effects on Demand Via the Forced Choice Task
Timeframe: After completion of study cigarette smoking session (Week 1, Week 2, Week 3)
3
Abuse Liability Via Puff Topography - Total Smoking Time
Timeframe: During study cigarette smoking session (Week 1, Week 2, Week 3)
4
Abuse Liability Via Puff Topography - Average Puff Duration
Timeframe: During study cigarette smoking session (Week 1, Week 2, Week 3)
5
Abuse Liability Via Puff Topography - Average Flow Rate
Timeframe: During study cigarette smoking session (Week 1, Week 2, Week 3)
6
Abuse Liability Via Puff Topography - Average Inter-Puff Interval
Timeframe: During study cigarette smoking session (Week 1, Week 2, Week 3)
7
Abuse Liability Via Puff Topography - Average Puff Volume
Trial details
NCT IDNCT06230159
SponsorOhio State University Comprehensive Cancer Center