Effects of Novel E-cigarette Constituents on Adults TCORS 3.0
- Conditions
- Nicotine Use Disorder
- Interventions
- Other: E-liquid coolant (Low WS-3) for non-menthol (2)Other: E-liquid coolant (Low WS-23) for non-menthol (4)Other: E-liquid coolant (Low WS-23) for low menthol (4)Other: E-liquid coolant (Low WS-3) for high menthol (2)Other: E-liquid coolant (No WS-3) for high menthol (1)Other: E-liquid coolant (High WS-3) for non-menthol (3)Other: E-liquid coolant (High WS-3) for high menthol (3)Other: E-liquid coolant (High WS-23) for high menthol (5)Other: E-liquid coolant (No WS-3) for non-menthol (1)Other: E-liquid coolant (No WS-3) for low menthol (1)Other: E-liquid coolant (High WS-23) for low menthol (5)Other: E-liquid coolant (Low WS-3) for low menthol (2)Other: E-liquid coolant (High WS-3) for low menthol (3)Other: E-liquid coolant (Low WS-23) for high menthol (4)Other: E-liquid coolant (High WS-23) for non-menthol (5)
- Registration Number
- NCT05932745
- Lead Sponsor
- Yale University
- Brief Summary
This study is an examination of the influence of cooling components of WS-3, WS-23, and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults.
- Detailed Description
The investigators will examine the influence of cooling components of WS-3, WS-23 (synthetic coolants) and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults. Participants will rate the flavor intensity, coolness, sweetness, and irritation/harshness, bitterness experienced using validated rating scales. 66 adult participants (18+ years of age) who are current e-cigarette users will participate in 3 laboratory sessions. Participants will receive 3 e-cigarette that contain cooling flavors and nicotine (59mg/ml nicotine salt) during the sessions. Participants will be randomized to receive one of the 3 menthol conditions (no-menthol, low menthol, high menthol) in combination three WS-3 conditions (no WS-3, low WS-3, high WS-3) and two WS-23 conditions (low WS-23, high WS-23). All participants will be exposed to all fifteen conditions across 3 lab sessions.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 66
- 18 years or older
- Able to read and write
- Some current e-cigarette use
- Willing to abstain from tobacco/nicotine use 2 hours prior to sessions
- Current use of non-prescription substances besides nicotine, marijuana, alcohol
- Any significant current medical or psychiatric condition
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Non-menthol, nicotine 59mg/ml (2) E-liquid coolant (Low WS-3) for non-menthol (2) Flavor without menthol with 59mg/ml nicotine Non-menthol, nicotine 59mg/ml (4) E-liquid coolant (Low WS-23) for non-menthol (4) Flavor without menthol with 59mg/ml nicotine Low menthol, nicotine 59mg/ml (4) E-liquid coolant (Low WS-23) for low menthol (4) Flavor low menthol concentration with 59mg/ml nicotine High menthol, nicotine 59mg/ml (2) E-liquid coolant (Low WS-3) for high menthol (2) Flavor with high menthol concentration with 59mg/ml nicotine High menthol, nicotine 59mg/ml (1) E-liquid coolant (No WS-3) for high menthol (1) Flavor with high menthol concentration with 59mg/ml nicotine Non-menthol, nicotine 59mg/ml (3) E-liquid coolant (High WS-3) for non-menthol (3) Flavor without menthol with 59mg/ml nicotine High menthol, nicotine 59mg/ml (3) E-liquid coolant (High WS-3) for high menthol (3) Flavor with high menthol concentration with 59mg/ml nicotine High menthol, nicotine 59mg/ml (5) E-liquid coolant (High WS-23) for high menthol (5) Flavor high menthol concentration with 59mg/ml nicotine Non-menthol, nicotine 59mg/ml (1) E-liquid coolant (No WS-3) for non-menthol (1) Flavor without menthol with 59mg/ml nicotine Low menthol, nicotine 59mg/ml (1) E-liquid coolant (No WS-3) for low menthol (1) Flavor with low menthol concentration with 59mg/ml nicotine Low menthol, nicotine 59mg/ml (5) E-liquid coolant (High WS-23) for low menthol (5) Flavor low menthol concentration with 59mg/ml nicotine Low menthol, nicotine 59mg/ml (2) E-liquid coolant (Low WS-3) for low menthol (2) Flavor with low menthol concentration with 59mg/ml nicotine Low menthol, nicotine 59mg/ml (3) E-liquid coolant (High WS-3) for low menthol (3) Flavor with low menthol concentration with 59mg/ml nicotine High menthol, nicotine 59mg/ml (4) E-liquid coolant (Low WS-23) for high menthol (4) Flavor high menthol concentration with 59mg/ml nicotine Non-menthol, nicotine 59mg/ml (5) E-liquid coolant (High WS-23) for non-menthol (5) Flavor without menthol with 59mg/ml nicotine
- Primary Outcome Measures
Name Time Method Liking: Score change in liking/wanting of each e-cigarette condition (5 conditions in total) Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 5 (at 130 minutes) The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking).
Reinforcing Efficacy: Score change in drug effects of each e-cigarette condition (5 conditions in total) Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 5 (at 130 minutes) Difference between e-cigarette effects for each e-cigarette condition as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm).
Irritation/Harshness: Score change in irritation of harshness of each e-cigarette condition (5 conditions in total) Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 5 (at 130 minutes) Difference in 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 Outcome Measures
Name Time Method Craving: Change in craving score for e-cigarette from baseline at each e-cigarette condition (5 conditions in total) At baseline (at 0 minute), following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 5 (at 130 minutes) Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e cigarettes 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).
Changes of salivary Nicotine and Cotinine Levels from baseline at each e-cigarette condition (5 conditions in total) At baseline (at 0 minute), Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 5 (at 130 minutes) Saliva samples will be collected following each exposure to product and before each lab sessions to assess change in nicotine/cotinine levels. These levels will be used for correlational analyses with behavioral measures and will be determined using LC/MS techniques at the core laboratory of university.