E-Cig Use
Conditions
Keywords
Cooling components, e-cigarette, menthol, WS-23, WS-3
Brief summary
This pilot sensory experiment will examine cooling from comparable concentrations of WS-3 and menthol to determine appropriate concentrations to use in the main study.
Detailed description
This pilot study will establish low and high concentrations of both WS-3 and menthol concentrations to test in the main study. An anticipated 30 adult e-cigarette users will participate in one laboratory session during which participants will be exposed to e-liquids containing five different concentrations of two different cooling flavors without nicotine (10 e-liquids total). Participants will rate "coolness" using the generalized Labeled Magnitude Scale (gLMS). Using averages of participant ratings, we will select a low concentration of each constituent that is rated as more than "barely detectable" but less than "moderate" to ensure that cooling is weak but clearly perceptible. For the high concentration of each constituent, we will select a concentration that on average falls between "strong" and "very strong" to identify a strong cooling sensation while avoiding sensations that would also be uncomfortable.
Interventions
OTHERE-liquid coolant (WS-3, 0.05%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.05%.
OTHERE-liquid coolant (WS-3, 0.1%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%.
OTHERE-liquid coolant (WS-3, 0.5%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%.
OTHERE-liquid coolant (WS-3, 1.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%.
OTHERE-liquid coolant (WS-3, 2.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%.
OTHERE-liquid coolant (menthol, 0.05%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.05%.
OTHERE-liquid coolant (menthol, 0.1%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%.
OTHERE-liquid coolant (menthol, 0.5%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%.
OTHERE-liquid coolant (menthol, 1.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%.
OTHERE-liquid coolant (menthol, 2.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%.
OTHERE-liquid coolant (WS-23, 0.05%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.05%.
OTHERE-liquid coolant (WS-23, 0.1%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.1%.
OTHERE-liquid coolant (WS-23, 0.5%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.5%.
OTHERE-liquid coolant (WS-23, 1.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 1.0%.
OTHERE-liquid coolant (WS-23, 2.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 2.0%.
OTHERE-liquid coolant (WS-23, 4.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 4.0%.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants will be exposed to e-liquids containing 16 conditions (WS-3 block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%, WS-23 block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%, 4.0%, and menthol block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%) from low concentration to high concentration.
Intervention model description
Participants are exposed to all study conditions (16 e-liquid samples).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Able to read and write * Used e-cigarettes containing nicotine * Use e-cigs in past 30 days * No strong dislike of the menthol flavor * Urine cotinine ≥200ng/ml * Willing to abstain from tobacco/nicotine use 2 hrs prior to sessions
Exclusion criteria
* Known hypersensitivity to propylene glycol * Pregnant or lactating females * Uncontrolled asthma * Nut/e-liquid flavorant allergy * Current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms * Dislike of menthol flavor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coolness: Score Change in Coolness of Each E-cigarette Condition (16 Conditions in Total) | Following administration of e-cigarette condition 1 (at 10 minutes), then 5 minutes post administration of each e-cigarette condition, up to 85 minutes (condition 16) | Difference in overall flavor intensity, coolness, sweetness and harshness/irritation at each e-cigarette condition as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSuchitra Krishnan-Sarin, PhD
Yale University
Participant flow
Recruitment details
Participants were recruited from the local community and university settings using flyers, email advertisements, and online postings. Individuals who expressed interest were screened for eligibility and checked during intakes, and those meeting inclusion criteria were scheduled for a single laboratory session. A total of 31 eligible participants were enrolled, and 30 completed the study procedures, 27 were analyzed
Pre-assignment details
Prior to completion of the lab session, one participant did not attend (due to no-show) and was therefore excluded from the final dataset. A total of 30 participants completed the laboratory procedures and were assigned to the study conditions.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.8 years old STANDARD_DEVIATION 9.7 |
| E-cigarette use frequency | 26.0 days STANDARD_DEVIATION 3.6 |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 4 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 7 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 16 Participants |
| Race/Ethnicity, Customized Others | 1 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
None listed