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Active, Not Recruiting

NCT Number: NCT06208202

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Abuse Tobacco Chemically-Induced Disorders Exposure Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

21 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

behavioral intervention

Behavioral

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

Biospecimen Collection

Other

Undergo biosample sample collection

Other names: Biological Sample Collection, Specimen Collection

Survey Administration

Other

Complete surveys

Primary outcomes

  1. Satisfaction and psychological reward

    Time frame: 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).

  2. Sensory perceptions of EC vaping experience

    Time frame: 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).

  3. E-cigarette puff topography

    Time frame: 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.

  4. Levels of HPHC and other toxicant exposure from vaping e-liquids

    Time frame: 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.

  5. Appeal and Sensory

    Time frame: 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 outcomes

  1. Economic demand breakpoint

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: ICE

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 17, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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