Perceptions of E-Cigarettes and Synthetic Cooling Agents, The ICE Study

N/ARecruitingNCT06208202

Ohio State University Comprehensive Cancer Center300 enrolled

Overview

This study evaluates how synthetic cooling additives like WS-3 and WS-23 impact e-cigarette perceptions, use behavior, and toxicant exposure.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

300

Conditions

Abuse Tobacco Exposure

Interventions

Behavioral InterventionBEHAVIORAL

Receive and use flavored e-cigarettes (EC) as directed

Biospecimen CollectionOTHER

Undergo biosample sample collection

Survey AdministrationOTHER

Complete surveys

Eligibility

Sex: ALLMin age: 21 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Satisfaction and psychological reward

Satisfaction and psychological reward of e-cigarette (EC) vaping will be measured by the Modified Cigarette Evaluation Questionnaire (mCEQ). The mCEQ asks questions relating to satisfaction of using e-cigarettes on a scale from 0 (Not at all) - 6 (Extremely).

Time frame: Minute 5 of vaping session, Minute 35 of vaping session

Sensory perceptions of EC vaping experience

Sensory perceptions of EC vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always).

Time frame: Pre-vaping session

E-cigarette puff topography

Will be measured with a topography device that records frequency, duration, and flow rate of EC puffs. These measures are combined to inform overall EC puff behavior.

Time frame: 35 Minute Vaping session

Levels of HPHC and other toxicant exposure from vaping e-liquids

Topography data collected for all participants for each of the conditions vaped will be averaged to produce four human-derived puffing regimens. Machine vaping will be conducted for each of the four e-liquids using the associated human-derived puffing regimens to determine the range of HPHCs and other toxicants in mainstream EC vapor.

Time frame: After completion of sessions, estimated 4 years

Appeal and Sensory

Participants will rate appeal (e.g., liking, disliking) and sensory attributes (e.g., harshness, coolness) outcomes on Visual Analogue Scales (range, 0-100).

Time frame: Minute 5 of vaping session, Minute 35 of vaping session

Secondary Outcomes

Economic demand breakpoint

Central Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066 OSUCCCClinicaltrials@osumc.edu

Data from ClinicalTrials.gov

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