CClinicalTrials.gg
Active, not recruitingNCT06208202ICEUpdated Jun 15, 2026

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

An interventional study of Behavioral Intervention and Biospecimen Collection in Abuse Tobacco and Exposure, sponsored by Ohio State University Comprehensive Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
21 Years to 29 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Abuse Tobacco
  • Exposure

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03

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 158 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
158 participants (actual)

Study arms

  • 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.

    Behavioral: Behavioral Intervention · Other: Biospecimen Collection · Other: Survey Administration

  • Active comparator
    Fruit flavored e-cigarette

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

    Behavioral: Behavioral Intervention · Other: Biospecimen Collection · Other: Survey Administration

  • 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.

    Behavioral: Behavioral Intervention · Other: Biospecimen Collection · Other: Survey Administration

  • Active comparator
    Tobacco flavored e-cigarette

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

    Behavioral: Behavioral Intervention · Other: Biospecimen Collection · Other: Survey Administration

Interventions

  • BehavioralBehavioral Intervention

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

  • OtherBiospecimen Collection

    Undergo biosample sample collection

    Also known as: Biological Sample Collection, Specimen Collection

  • OtherSurvey Administration

    Complete surveys

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  1. 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.

    Time frame: Minute 35 of vaping session

07

Study locations

1 site
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06208202
Lead sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Alayna Tackett (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Jan 17, 2024
Start date
May 8, 2024
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Jun 15, 2026

Study contacts

Alayna P Tackett, PhD
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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