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

The Ohio State University

Status: Enrolling

Conditions: Exposure; Abuse Tobacco

Treatments: Behavioral: Behavioral Intervention; Other: Biospecimen Collection; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06208202

OSU-23040

NCI-2023-06312 (Registry Identifier)

R01CA276696 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

300 participants in 4 patient groups

Fruit flavored e-cigarette with synthetic cooling agents added

Active Comparator group

Description:

Synthetic cooling agents will be added to fruit flavored e-liquid for this condition.

Treatment:

Other: Survey Administration

Other: Biospecimen Collection

Behavioral: Behavioral Intervention

Fruit flavored e-cigarette

Active Comparator group

Description:

Fruit flavored e-liquid will be used for this condition.

Treatment:

Other: Survey Administration

Other: Biospecimen Collection

Behavioral: Behavioral Intervention

Tobacco flavored e-cigarette with synthetic cooling agents added

Active Comparator group

Description:

Synthetic cooling agents will be added to tobacco flavored e-liquid for this condition.

Treatment:

Other: Survey Administration

Other: Biospecimen Collection

Behavioral: Behavioral Intervention

Tobacco flavored e-cigarette

Active Comparator group

Description:

Tobacco flavored e-liquid will be used for this condition.

Treatment:

Other: Survey Administration

Other: Biospecimen Collection

Behavioral: Behavioral Intervention