Effects of Novel E-cigarette Constituents on Adults TCORS 3.0
ConditionNicotine Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Able to read and write
Some current e-cigarette use
Urine cotinine ≥200ng/ml
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
E-liquid coolant (No WS-3) for non-menthol (1)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
E-liquid coolant (No WS-3) for low (0.1%) menthol (1)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
E-liquid coolant (No WS-3) for high (2.0%) menthol (1)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (High [2.0%] WS-3) for non-menthol (3)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (High [2.0%] WS-23) for non-menthol (5)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.
E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.
E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.
E-liquid coolant (4% WS-23) for non-menthol (6)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.
E-liquid coolant (4% WS-23) for low (0.1%) menthol (6)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.
E-liquid coolant (4% WS-23) for high (2.0%) menthol (6)
Other interventionAdult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.
Treatment groups
66 Participants
are divided into 18 treatment groups18
Treatment groupsSee each treatment group below.
Group A: Non-menthol, nicotine 59mg/ml (1)Experimental treatment 1 intervention
Group B: Low (0.1%) menthol, nicotine 59mg/ml (1)Experimental treatment 1 intervention
Group C: High (2.0%) menthol, nicotine 59mg/ml (1)Experimental treatment 1 intervention
Group D: Non-menthol, nicotine 59mg/ml (2)Experimental treatment 1 intervention
Group E: Low (0.1%) menthol, nicotine 59mg/ml (2)Experimental treatment 1 intervention
Group F: High (2.0%) menthol, nicotine 59mg/ml (2)Experimental treatment 1 intervention
Group G: Non-menthol, nicotine 59mg/ml (3)Experimental treatment 1 intervention
Group H: Low (0.1%) menthol, nicotine 59mg/ml (3)Experimental treatment 1 intervention
Group I: High (2.0%) menthol, nicotine 59mg/ml (3)Experimental treatment 1 intervention
Group J: Non-menthol, nicotine 59mg/ml (4)Experimental treatment 1 intervention
Group K: Low (0.1%) menthol, nicotine 59mg/ml (4)Experimental treatment 1 intervention
Group L: High (2.0%) menthol, nicotine 59mg/ml (4)Experimental treatment 1 intervention
Group M: Non-menthol, nicotine 59mg/ml (5)Experimental treatment 1 intervention
Group N: Low (0.1%) menthol, nicotine 59mg/ml (5)Experimental treatment 1 intervention
Group O: High (2.0%) menthol, nicotine 59mg/ml (5)Experimental treatment 1 intervention
Group P: Non-menthol, nicotine 59mg/ml (6)Experimental treatment 1 intervention
Group Q: Low (0.1%) menthol, nicotine 59mg/ml (6)Experimental treatment 1 intervention
Group R: High (2.0%) menthol, nicotine 59mg/ml (6)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Liking: Score change in liking/wanting of each e-cigarette condition (5 conditions in total)
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).
Time frame
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 6 (at 160 minutes)2
Reinforcing Efficacy: Score change in drug effects of each e-cigarette condition (5 conditions in total)
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).
Time frame
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 6 (at 160 minutes)3
Irritation/Harshness: Score change in irritation of harshness of each e-cigarette condition (5 conditions in total)
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).
Time frame
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 6 (at 160 minutes)Secondary outcomes
1
Craving: Change in craving score for e-cigarette from baseline at each e-cigarette condition (5 conditions in total)
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).
Time frame
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 6 (at 160 minutes)2
Changes of salivary Nicotine and Cotinine Levels from baseline at each e-cigarette condition (6 conditions in total)
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.
Time frame
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 6 (at 160 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov