Examine the Effects of Novel E-cigarette Constituents and Determining Appropriate Concentrations Among Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Coolness: Score Change in Coolness of Each E-cigarette Condition (16 Conditions in Total)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
WS-23 (6), no nicotine
WS-23 block: 4.0%
Intervention: E-liquid coolant (WS-23, 4.0%) (Other)
WS-3 (1), no nicotine
WS-3 block: 0.05%
Intervention: E-liquid coolant (WS-3, 0.05%) (Other)
WS-3 (2), no nicotine
WS-3 block: 0.1%
Intervention: E-liquid coolant (WS-3, 0.1%) (Other)
WS-3 (3), no nicotine
WS-3 block: 0.5%
Intervention: E-liquid coolant (WS-3, 0.5%) (Other)
WS-3 (4), no nicotine
WS-3 block: 1.0%
Intervention: E-liquid coolant (WS-3, 1.0%) (Other)
WS-3 (5), no nicotine
WS-3 block: 2.0%
Intervention: E-liquid coolant (WS-3, 2.0%) (Other)
Menthol (1), no nicotine
Menthol block: 0.05%
Intervention: E-liquid coolant (menthol, 0.05%) (Other)
Menthol (2), no nicotine
Menthol block: 0.1%
Intervention: E-liquid coolant (menthol, 0.1%) (Other)
Menthol (3), no nicotine
Menthol block: 0.5%
Intervention: E-liquid coolant (menthol, 0.5%) (Other)
Menthol (4), no nicotine
Menthol block: 1.0%
Intervention: E-liquid coolant (menthol, 1.0%) (Other)
Menthol (5), no nicotine
Menthol block: 2.0%
Intervention: E-liquid coolant (menthol, 2.0%) (Other)
WS-23 (1), no nicotine
WS-23 block: 0.05%
Intervention: E-liquid coolant (WS-23, 0.05%) (Other)
WS-23 (2), no nicotine
WS-23 block: 0.1%
Intervention: E-liquid coolant (WS-23, 0.1%) (Other)
WS-23 (3), no nicotine
WS-23 block: 0.5%
Intervention: E-liquid coolant (WS-23, 0.5%) (Other)
WS-23 (4), no nicotine
WS-23 block: 1.0%
Intervention: E-liquid coolant (WS-23, 1.0%) (Other)
WS-23 (5), no nicotine
WS-23 block: 2.0%
Intervention: E-liquid coolant (WS-23, 2.0%) (Other)
Outcomes
Primary Outcomes
Coolness: Score Change in Coolness of Each E-cigarette Condition (16 Conditions in Total)
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported