Clinical trial NCT06208202: Perceptions of E-Cigarettes and Synthetic Cooling Agents, the ICE Study
Official title: The ICE Study: Perceptions of E-Cigarettes and Synthetic Cooling Agents (R01)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abuse Tobacco
Exposure
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-17
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomization to condition order will be completed prior to study Visit 1. Each participant will receive a randomized ordering developed using a random sequence generator. Participants and data collection staff will be blinded to the order/conditions administered at each trial. The sequence list and subsequent participant ID numbers will be kept separate from data collection staff and will only be accessible by staff who will not be interacting with participants.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Aged 21-29 years
* Current exclusive 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

Primary outcomes:
measure: Satisfaction and psychological reward
timeFrame: Minute 5 of vaping session, Minute 35 of vaping session
measure: Sensory perceptions of EC vaping experience
timeFrame: Pre-vaping session
measure: E-cigarette puff topography
timeFrame: 35 Minute Vaping session
measure: Levels of HPHC and other toxicant exposure from vaping e-liquids
timeFrame: After completion of sessions, estimated 4 years
measure: Appeal and Sensory
timeFrame: Minute 5 of vaping session, Minute 35 of vaping session
Secondary outcomes:
measure: Economic demand breakpoint
timeFrame: Minute 35 of vaping session
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Alayna P Tackett, PhD
role: PRINCIPAL_INVESTIGATOR
References: