Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT06208202
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perceptions of E-Cigarettes and Synthetic Cooling Agents, the ICE Study
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
The ICE Study: Perceptions of E-Cigarettes and Synthetic Cooling Agents (R01)
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICE
Brief Summary:
This study evaluates how synthetic cooling additives like WS-3 and WS-23 impact e-cigarette perceptions, use behavior, and toxicant exposure.
Detailed Description:
PRIMARY OBJECTIVES:
I. Assess the abuse liability of e-liquids with and without the presence of synthetic cooling agents.
II. Determine the impact of synthetic cooling agents and flavor on EC puffing behavior (topography).
III. Determine the exposure ranges (harmful and potentially harmful constituents \[HPHCs\], other toxicants) from vaping e-liquids with and without the presence of synthetic cooling agents.
OUTLINE:
Participants attend 4 sessions where they receive 1 of 4 randomly assigned flavored e-cigarettes. Participants use the e cigarettes for vaping followed by ad libitum vaping. Participants also complete surveys and undergo biosample collection throughout the study.
I. Assess the abuse liability of e-liquids with and without the presence of synthetic cooling agents.
II. Determine the impact of synthetic cooling agents and flavor on EC puffing behavior (topography).
III. Determine the exposure ranges (harmful and potentially harmful constituents \[HPHCs\], other toxicants) from vaping e-liquids with and without the presence of synthetic cooling agents.
OUTLINE:
Participants attend 4 sessions where they receive 1 of 4 randomly assigned flavored e-cigarettes. Participants use the e cigarettes for vaping followed by ad libitum vaping. Participants also complete surveys and undergo biosample collection throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-06312 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| R01CA276696 | NIH | None | https://reporter.nih.gov/quic… | View |