Abuse TobaccoICENCT06208202
Perceptions of E-Cigarettes and Synthetic Cooling Agents, The ICE Study
A study testing Behavioral Intervention, Biospecimen Collection and Survey Administration in people with Abuse Tobacco and Exposure, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study evaluates how synthetic cooling additives like WS-3 and WS-23 impact e-cigarette perceptions, use behavior, and toxicant exposure. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Abuse Tobacco, Exposure
- What is being tested?
- Behavioral Intervention, Biospecimen Collection and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Abuse Tobacco, Exposure
- Being tested
- Behavioral Intervention, Biospecimen Collection, Survey Administration
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Receive and use flavored e-cigarettes (EC) as directed
Biospecimen CollectionOther
Also called Biological Sample Collection, Specimen Collection
Undergo biosample sample collection
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Behavioral Intervention; Other: Biospecimen Collection; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Minute 35 of vaping session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start8 May 2024
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse TobaccoStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alayna Tackett, Ohio State University Comprehensive Cancer Center
- Investigators
- Alayna P Tackett, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208202
- Sponsor's protocol ID
- OSU-23040
- Other IDs
- NCI-2023-06312, R01CA276696
- Acronym
- ICE
- Status last verified
- Jun 2026
- First submitted
- 30 Nov 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ICE Study: Perceptions of E-Cigarettes and Synthetic Cooling Agents (R01)
- ClinicalTrials.gov ID
- NCT06208202
- Acronym / sponsor ID
- ICE / OSU-23040
- Conditions
- Abuse Tobacco, Exposure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 May 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates how synthetic cooling additives like WS-3 and WS-23 impact e-cigarette perceptions, use behavior, and toxicant exposure.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fruit flavored e-cigarette with synthetic cooling agents added | Active comparator | Behavioral: Behavioral Intervention, Other: Biospecimen Collection, Other: Survey AdministrationSynthetic cooling agents will be added to fruit flavored e-liquid for this condition. |
| Fruit flavored e-cigarette | Active comparator | Behavioral: Behavioral Intervention, Other: Biospecimen Collection, Other: Survey AdministrationFruit flavored e-liquid will be used for this condition. |
| Tobacco flavored e-cigarette with synthetic cooling agents added | Active comparator | Behavioral: Behavioral Intervention, Other: Biospecimen Collection, Other: Survey AdministrationSynthetic cooling agents will be added to tobacco flavored e-liquid for this condition. |
| Tobacco flavored e-cigarette | Active comparator | Behavioral: Behavioral Intervention, Other: Biospecimen Collection, Other: Survey AdministrationTobacco flavored e-liquid will be used for this condition. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionReceive and use flavored e-cigarettes (EC) as directed | Behavioural | 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 CollectionAlso: Biological Sample Collection, Specimen CollectionUndergo biosample sample collection | Other | 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 AdministrationComplete surveys | Other | 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 |
Primary outcome
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).
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).
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.
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.
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).
1 secondary outcome
Economic demand breakpoint
Time frame: Minute 35 of vaping session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alayna P Tackett, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Biospecimen Collection and Survey Administration in people with Abuse Tobacco and Exposure, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction and psychological reward (time frame: Minute 5 of vaping session, Minute 35 of vaping session). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.