- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06868368
Perceptions of Vaping Products
Perceptions of Vaping Products Among Young Adults
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. Assess the pharmacokinetics of metatine and nicotine electronic (e)-cigarettes.
II. Assess the abuse liability and appeal of commercial e-cigarettes containing metatine versus nicotine.
III. Determine the impact of metatine on e-cigarette puffing behavior (topography).
OUTLINE: Participants attend 3 sessions where they will be randomized to 1 of 3 types of e-cigarette. Participants will use the e-cigarette ad-libitum for 30 minutes and answer survey questions about their perceptions of the e-cigarette. Participants must also undergo 4 blood draws during the vaping session.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 21-34 years
- Current nicotine EC user (defined as ≥ weekly use over the past 3 months)
- Willing to provide informed consent and abstain from using any e-cigarette at least 12 hours prior to the three lab sessions
- Read and speak English
Exclusion Criteria:
- Recently coronavirus disease 2019 (COVID-19) positive (defined as a 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
- Have suffered from any serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days
- Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)
- Have hemophilia or another type of bleeding disorder
- Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Participant's personal nicotine e-cigarette
The study participant's own preferred e-cigarette will be used for this condition.
|
Undergo blood sample collection
Other Names:
Complete Surveys
Use e-cigarette connected to a topography device
Participant vapes their own preferred e-cigarette for 30 minutes
|
|
Active Comparator: Nicotine e-cigarette
A fruit flavored commercially available nicotine e-cigarette will be used for this condition.
|
Undergo blood sample collection
Other Names:
Complete Surveys
Use e-cigarette connected to a topography device
Participant vapes a commercially available nicotine e-cigarette for 30 minutes
|
|
Active Comparator: 6-methyl nicotine (metatine) e-cigarette
A fruit flavored commercially available metatine e-cigarette will be used for this condition.
|
Undergo blood sample collection
Other Names:
Complete Surveys
Use e-cigarette connected to a topography device
Participant vapes a commercially available metatine e-cigarette for 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics of metatine and nicotine e-cigarettes
Time Frame: Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session
|
Pharmacokinetics of metatine and nicotine e-cigarettes will be examined by measuring the concentration of metatine and nicotine in blood plasma at different timepoints throughout the study vaping session.
|
Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session
|
|
Sensory perceptions of EC vaping experience
Time Frame: Minute 5 of vaping session, Minute 30 of vaping session
|
Sensory perceptions of 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).
|
Minute 5 of vaping session, Minute 30 of vaping session
|
|
Relief of withdrawal symptoms
Time Frame: Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session
|
Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS).
The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None, Slight, Moderate, Mild, or Severe.
|
Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session
|
|
E-cigarette puffing behavior
Time Frame: Week 1, Week 2, Week 3
|
E-cigarette puffing behavior will be measured with a topography device that records frequency, duration, and flow rate of e-cigarette puffs.
These measures are combined to inform the overall measure of e-cigarette puffing behavior.
|
Week 1, Week 2, Week 3
|
|
Appeal ratings
Time Frame: Minute 5 of vaping session, Minute 30 of vaping session
|
Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100).
|
Minute 5 of vaping session, Minute 30 of vaping session
|
|
Sensory ratings
Time Frame: Minute 5 of vaping session, Minute 30 of vaping session
|
Participants will rate sensory attributes (e.g., harshness, coolness) on Visual Analogue Scales (range, 0-100).
|
Minute 5 of vaping session, Minute 30 of vaping session
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alayna P Tackett, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-24276
- NCI-2024-10267 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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