Clinical trial NCT05932745: Effects of Novel E-cigarette Constituents on Adults TCORS 3.0
Official title: Examining Appeal and Addiction Potential of Novel E-cigarette Constituents Among Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Use Disorder
Keywords: Menthol, cooling components, cigarette, e-cigarette, vaping
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-07-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants receive all 15 study conditions.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Liking: Score change in liking/wanting of each e-cigarette condition (5 conditions in total)
timeFrame: 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)
measure: Reinforcing Efficacy: Score change in drug effects of each e-cigarette condition (5 conditions in total)
timeFrame: 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)
measure: Irritation/Harshness: Score change in irritation of harshness of each e-cigarette condition (5 conditions in total)
timeFrame: 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)
Secondary outcomes:
measure: Craving: Change in craving score for e-cigarette from baseline at each e-cigarette condition (5 conditions in total)
timeFrame: 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)
measure: Changes of salivary Nicotine and Cotinine Levels from baseline at each e-cigarette condition (5 conditions in total)
timeFrame: 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)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: JB Pierce Lab
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim J, Wood A, Green BG. Derivation and evaluation of a labeled hedonic scale. Chem Senses. 2009 Nov;34(9):739-51. doi: 10.1093/chemse/bjp054.