Evaluating the effects of cooling agents in e-cigarettes
The ICE Study: Perceptions of E-Cigarettes and Synthetic Cooling Agents (R01)
NA · Ohio State University Comprehensive Cancer Center · NCT06208202
This study is testing how different cooling agents in e-cigarettes affect how young adult users feel about them, how they use them, and their exposure to harmful substances.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 21 Years to 29 Years |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06208202 on ClinicalTrials.gov |
What this trial studies
This study investigates how synthetic cooling additives, such as WS-3 and WS-23, influence perceptions of e-cigarettes, user behavior, and exposure to toxicants. Participants aged 21-29 who are current exclusive e-cigarette users will attend four sessions where they will use one of four randomly assigned flavored e-cigarettes. The study aims to assess the abuse liability of these e-liquids, analyze puffing behavior, and measure exposure to harmful constituents. Surveys and biosample collections will be conducted throughout the sessions to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 21-29 who are current exclusive e-cigarette users.
Not a fit: Patients who are not current e-cigarette users or have significant psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer e-cigarette formulations and inform public health strategies.
How similar studies have performed: While studies on e-cigarettes exist, the specific focus on synthetic cooling agents is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 21-29 years * Current e-cigarette (EC) user (defined as ≥ weekly use over the past 3 months) * Willing to provide informed consent and abstain from using their EC at least 12 hours prior to the four lab sessions * Read and speak English Exclusion Criteria: * Recently COVID-19+ (defined as positive test in the past 30 days) or a recent COVID-19 hospitalization (defined as a hospitalization within the past 6 months) * Unstable or significant psychiatric conditions (past and stable conditions will be allowed) * History of cardiac event or distress within the past 3 months * Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test) * Have suffered from any serious lung disease or infection (e.g. , tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days * Have hemophilia or another type of bleeding disorder * Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Alayna P Tackett, PhD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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: Abuse Tobacco, Exposure