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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2028-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Abuse Tobacco Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants and study staff will be blinded to the study conditions delivered at each visit.

Study Groups

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Fruit flavored e-cigarette with synthetic cooling agents added

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

Group Type ACTIVE_COMPARATOR

Behavioral Intervention

Intervention Type BEHAVIORAL

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

Biospecimen Collection

Intervention Type OTHER

Undergo biosample sample collection

Survey Administration

Intervention Type OTHER

Complete surveys

Fruit flavored e-cigarette

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

Group Type ACTIVE_COMPARATOR

Behavioral Intervention

Intervention Type BEHAVIORAL

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

Biospecimen Collection

Intervention Type OTHER

Undergo biosample sample collection

Survey Administration

Intervention Type OTHER

Complete surveys

Tobacco flavored e-cigarette with synthetic cooling agents added

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

Group Type ACTIVE_COMPARATOR

Behavioral Intervention

Intervention Type BEHAVIORAL

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

Biospecimen Collection

Intervention Type OTHER

Undergo biosample sample collection

Survey Administration

Intervention Type OTHER

Complete surveys

Tobacco flavored e-cigarette

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

Group Type ACTIVE_COMPARATOR

Behavioral Intervention

Intervention Type BEHAVIORAL

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

Biospecimen Collection

Intervention Type OTHER

Undergo biosample sample collection

Survey Administration

Intervention Type OTHER

Complete surveys

Interventions

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Behavioral Intervention

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

Intervention Type BEHAVIORAL

Biospecimen Collection

Undergo biosample sample collection

Intervention Type OTHER

Survey Administration

Complete surveys

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Specimen Collection

Eligibility Criteria

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Inclusion Criteria

* Aged 21-29 years
* Current exclusive 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes