Abuse Tobacco, Exposure
Conditions
Brief summary
This clinical trial studies the effects, appeal, and abuse liability of 6-methyl nicotine (metatine) electronic cigarettes among young adults.
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.
Interventions
OTHERBiospecimen Collection
Undergo blood sample collection
OTHERSurvey Administration
Complete Surveys
BEHAVIORALVaping Topography
Use e-cigarette connected to a topography device
OTHERParticipant's Own Preferred E-cigarette
Participant vapes their own preferred e-cigarette for 30 minutes
OTHERNicotine E-cigarette
Participant vapes a commercially available nicotine e-cigarette for 30 minutes
OTHER6-methyl-nicotine (metatine) e-cigarette
Participant vapes a commercially available metatine e-cigarette for 30 minutes
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 34 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of metatine and nicotine e-cigarettes | 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. |
| E-cigarette puffing behavior | 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. |
| Sensory perceptions of EC vaping experience | 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). |
| Appeal ratings | 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). |
| Sensory ratings | 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). |
| Relief of withdrawal symptoms | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlayna P Tackett, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed