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

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

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

Study Overview

• Status: Recruiting
• Conditions: Exposure; Abuse Tobacco
• Intervention / Treatment: Other: Survey Administration; Behavioral: Behavioral Intervention; Other: Biospecimen Collection

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Alayna P. Tackett, PhD
      • Principal Investigator: Alayna P. Tackett, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fruit flavored e-cigarette with synthetic cooling agents added; Synthetic cooling agents will be added to fruit flavored e-liquid for this condition.	Other: Survey Administration; Complete surveys; Behavioral: Behavioral Intervention; Receive and use flavored e-cigarettes (EC) as directed; Other: Biospecimen Collection; Undergo biosample sample collection; Other Names: Biological Sample Collection; Specimen Collection
Active Comparator: Tobacco flavored e-cigarette with synthetic cooling agents added; Synthetic cooling agents will be added to tobacco flavored e-liquid for this condition.	Other: Survey Administration; Complete surveys; Behavioral: Behavioral Intervention; Receive and use flavored e-cigarettes (EC) as directed; Other: Biospecimen Collection; Undergo biosample sample collection; Other Names: Biological Sample Collection; Specimen Collection
Active Comparator: Fruit flavored e-cigarette; Fruit flavored e-liquid will be used for this condition.	Other: Survey Administration; Complete surveys; Behavioral: Behavioral Intervention; Receive and use flavored e-cigarettes (EC) as directed; Other: Biospecimen Collection; Undergo biosample sample collection; Other Names: Biological Sample Collection; Specimen Collection
Active Comparator: Tobacco flavored e-cigarette; Tobacco flavored e-liquid will be used for this condition.	Other: Survey Administration; Complete surveys; Behavioral: Behavioral Intervention; Receive and use flavored e-cigarettes (EC) as directed; Other: Biospecimen Collection; Undergo biosample sample collection; Other Names: Biological Sample Collection; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alayna P Tackett, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: OSU-23040; NCI-2023-06312 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA276696 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No