N/A
N=32
Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use
Cigarette Smoking-Related Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT06230159 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2026
Primary outcome: Primary: Cigarette Chemical Contents — 22.86; 22.30; 21.42; 1.64 mg/g of tobacco rod
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-menthol Cigarette Smoking (Behavioral); Menthol Cigarette Smoking (Behavioral); Synthetic Cooling Agent Cigarette Smoking (Behavioral); Usual Brand Cigarette Smoking (Behavioral); Spirometry (Diagnostic_test); Questionnaire Administration (Other); Nasal Epithelial Lining Fluid (Diagnostic_test)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarette Chemical Contents |
22.86; 22.30; 21.42; 1.64; 0; 0 | — |
| PRIMARY Impact of Cooling Effects on Demand Via the Forced Choice Task |
9; 6; 9 | — |
| PRIMARY Abuse Liability Via Puff Topography - Total Smoking Time |
255.00; 280.41; 236.49 | — |
| PRIMARY Abuse Liability Via Puff Topography - Average Puff Duration |
1.60; 1.62; 1.68 | — |
| PRIMARY Abuse Liability Via Puff Topography - Average Flow Rate |
25.18; 25.92; 25.13 | — |
| PRIMARY Abuse Liability Via Puff Topography - Average Inter-Puff Interval |
20.05; 21.94; 20.34 | — |
| PRIMARY Abuse Liability Via Puff Topography - Average Puff Volume |
38.17; 39.60; 39.97 | — |
| PRIMARY Cigarette Appeal |
58.87; 53.57; 52.83; 33.97; 35.20; 39.73 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06230159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.