Perceptions of E-Cigarettes and Synthetic Cooling Agents, the ICE Study
- Conditions
- Abuse TobaccoExposure
- Interventions
- Behavioral: Behavioral InterventionOther: Biospecimen CollectionOther: Survey Administration
- Registration Number
- NCT06208202
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fruit flavored e-cigarette with synthetic cooling agents added Behavioral Intervention Synthetic cooling agents will be added to fruit flavored e-liquid for this condition. Fruit flavored e-cigarette with synthetic cooling agents added Biospecimen Collection Synthetic cooling agents will be added to fruit flavored e-liquid for this condition. Fruit flavored e-cigarette Behavioral Intervention Fruit flavored e-liquid will be used for this condition. Tobacco flavored e-cigarette with synthetic cooling agents added Biospecimen Collection Synthetic cooling agents will be added to tobacco flavored e-liquid for this condition. Tobacco flavored e-cigarette with synthetic cooling agents added Survey Administration Synthetic cooling agents will be added to tobacco flavored e-liquid for this condition. Fruit flavored e-cigarette with synthetic cooling agents added Survey Administration Synthetic cooling agents will be added to fruit flavored e-liquid for this condition. Fruit flavored e-cigarette Biospecimen Collection Fruit flavored e-liquid will be used for this condition. Fruit flavored e-cigarette Survey Administration Fruit flavored e-liquid will be used for this condition. Tobacco flavored e-cigarette with synthetic cooling agents added Behavioral Intervention Synthetic cooling agents will be added to tobacco flavored e-liquid for this condition. Tobacco flavored e-cigarette Behavioral Intervention Tobacco flavored e-liquid will be used for this condition. Tobacco flavored e-cigarette Survey Administration Tobacco flavored e-liquid will be used for this condition. Tobacco flavored e-cigarette Biospecimen Collection Tobacco flavored e-liquid will be used for this condition.
- Primary Outcome Measures
Name Time Method Satisfaction and psychological reward Minute 5 of vaping session, Minute 35 of vaping session 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).
Sensory perceptions of EC vaping experience Pre-vaping session 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).
E-cigarette puff topography 35 Minute Vaping session 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.
Levels of HPHC and other toxicant exposure from vaping e-liquids After completion of sessions, estimated 4 years 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.
Appeal and Sensory Minute 5 of vaping session, Minute 35 of vaping session Participants will rate appeal (e.g., liking, disliking) and sensory attributes (e.g., harshness, coolness) outcomes on Visual Analogue Scales (range, 0-100).
- Secondary Outcome Measures
Name Time Method Economic demand breakpoint Minute 35 of vaping session The price point at which a participant is no longer willing to pay for a puff of the study e-liquid will be determined by an EC purchase task questionnaire.
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States