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

NCT06208202 | Recruiting

• 3 other identifiers: OSU-23040NCI-2023-06312R01CA276696
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abuse Tobacco; Exposure

Outcome Measures

Primary Outcomes (5)

• 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).

  Pre-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

• 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).

  Minute 5 of vaping session, Minute 35 of vaping session

Secondary Outcomes (1)

• Economic demand breakpoint

  Minute 35 of vaping session

Study Arms (4)

Fruit flavored e-cigarette with synthetic cooling agents added

ACTIVE COMPARATOR

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

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

Fruit flavored e-cigarette

ACTIVE COMPARATOR

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

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

Tobacco flavored e-cigarette with synthetic cooling agents added

ACTIVE COMPARATOR

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

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

Tobacco flavored e-cigarette

ACTIVE COMPARATOR

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

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

Interventions

Behavioral Intervention BEHAVIORAL

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

Fruit flavored e-cigarette; Fruit flavored e-cigarette with synthetic cooling agents added; Tobacco flavored e-cigarette; Tobacco flavored e-cigarette with synthetic cooling agents added

Biospecimen Collection OTHER

Undergo biosample sample collection

Also known as: Biological Sample Collection, Specimen Collection

Fruit flavored e-cigarette; Fruit flavored e-cigarette with synthetic cooling agents added; Tobacco flavored e-cigarette; Tobacco flavored e-cigarette with synthetic cooling agents added

Survey Administration OTHER

Complete surveys

Fruit flavored e-cigarette; Fruit flavored e-cigarette with synthetic cooling agents added; Tobacco flavored e-cigarette; Tobacco flavored e-cigarette with synthetic cooling agents added

Eligibility Criteria

• Age: 21 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Behavior Therapy; Specimen Handling

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Alayna P Tackett, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and study staff will be blinded to the study conditions delivered at each visit.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomization to condition order will be completed prior to study Visit 1. Each participant will receive a randomized ordering developed using a random sequence generator. Participants and data collection staff will be blinded to the order/conditions administered at each trial. The sequence list and subsequent participant ID numbers will be kept separate from data collection staff and will only be accessible by staff who will not be interacting with participants.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 17, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)