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

Exposure Clinical Trial

— ICE  

Official title:

The ICE Study: Perceptions of E-Cigarettes and Synthetic Cooling Agents (R01)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208202
• Other study ID #: OSU-23040
• Secondary ID: NCI-2023-06312R0
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: June 2028

Study information

• Verified date: May 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 29 Years

Eligibility

Inclusion Criteria:

• Aged 21-29 years

• Current exclusive e-cigarette (EC) user (defined as = weekly use over the past 3 months)

• Not currently using another tobacco/nicotine product (defined as no use in the past 6 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

Related Conditions & MeSH terms

• Exposure
• Tobacco Use Disorder

Intervention

Behavioral:
• Behavioral Intervention
Receive and use flavored e-cigarettes (EC) as directed

Other:
• Biospecimen Collection
Undergo biosample sample collection
• Survey Administration
Complete surveys

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Minute 5 of vaping session, Minute 35 of vaping session
Primary	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).	Minute 5 of vaping session, Minute 35 of vaping session
Primary	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.	35 Minute Vaping session
Primary	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.	After completion of sessions, estimated 4 years
Secondary	Economic demand breakpoint	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.	Minute 35 of vaping session

External Links

•   The Jamesline