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Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05932745
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
66
Enrollment
9
Arms
26
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is an examination of the influence of cooling components of WS-3 and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults.

Condition or Disease Intervention/Treatment Phase
  • Other: E-liquid coolant (no WS-3) (1)
  • Other: E-liquid coolant (Low WS-3) (1)
  • Other: E-liquid coolant (High WS-3) (1)
  • Other: E-liquid coolant (no WS-3) (2)
  • Other: E-liquid coolant (Low WS-3) (2)
  • Other: E-liquid coolant (High WS-3) (2)
  • Other: E-liquid coolant (no WS-3) (3)
  • Other: E-liquid coolant (Low WS-3) (3)
  • Other: E-liquid coolant (High WS-3) (3)
 N/A

Detailed Description

The investigators will examine the influence of cooling components of WS-3 (a synthetic coolant) 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). All participants will be exposed to all nine conditions across 3 lab sessions.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
All participants receive all 9 study conditions.All participants receive all 9 study conditions.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Participants will be given a nicotine containing e-cigarette that could have various levels of cooling flavoring. Participants will not be told the nicotine concentration of the product or the type or concentration of the added coolant or what order it is presented in. Investigator and research assistant (i.e. care provider) will know the doses of nicotine and coolant, but will not know what order coolants are presented to participants.
Primary Purpose:
Other
Official Title:
Examining Appeal and Addiction Potential of Novel E-cigarette Constituents Among Adults
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Non-menthol, nicotine 59mg/ml (1)

Flavor without menthol with 59mg/ml nicotine

Other: E-liquid coolant (no WS-3) (1)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
Other Names:
  • Flavor type

    		•
    Experimental: Low menthol, nicotine 59mg/ml (1)

    Flavor with low menthol concentration with 59mg/ml nicotine

    Other: E-liquid coolant (Low WS-3) (1)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
    Other Names:
  • Flavor type

    		•
    Experimental: High menthol, nicotine 59mg/ml (1)

    Flavor with high menthol concentration with 59mg/ml nicotine

    Other: E-liquid coolant (High WS-3) (1)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
    Other Names:
  • Flavor type

    		•
    Experimental: Non-menthol, nicotine 59mg/ml (2)

    Flavor without menthol with 59mg/ml nicotine

    Other: E-liquid coolant (Low WS-3) (2)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
    Other Names:
  • Flavor type

    		•
    Experimental: Low menthol, nicotine 59mg/ml (2)

    Flavor with low menthol concentration with 59mg/ml nicotine

    Other: E-liquid coolant (no WS-3) (2)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
    Other Names:
  • Flavor type

    		•
    Experimental: High menthol, nicotine 59mg/ml (2)

    Flavor with high menthol concentration with 59mg/ml nicotine

    Other: E-liquid coolant (Low WS-3) (3)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
    Other Names:
  • Flavor type

    		•
    Experimental: Non-menthol, nicotine 59mg/ml (3)

    Flavor without menthol with 59mg/ml nicotine

    Other: E-liquid coolant (High WS-3) (2)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
    Other Names:
  • Flavor type

    		•
    Experimental: Low menthol, nicotine 59mg/ml (3)

    Flavor with low menthol concentration with 59mg/ml nicotine

    Other: E-liquid coolant (High WS-3) (3)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
    Other Names:
  • Flavor type

    		•
    Experimental: High menthol, nicotine 59mg/ml (3)

    Flavor with high menthol concentration with 59mg/ml nicotine

    Other: E-liquid coolant (no WS-3) (3)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
    Other Names:
  • Flavor type

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Liking: Score change in liking/wanting of each e-cigarette condition (3 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 3 (at 70 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).

    2. Reinforcing Efficacy: Score change in drug effects of each e-cigarette condition (3 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 3 (at 70 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).

    3. Irritation/Harshness: Score change in irritation of harshness of each e-cigarette condition (3 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 3 (at 70 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

    1. Craving: Change in craving score for e-cigarette from baseline at each e-cigarette condition (3 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 3 (at 70 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).

    2. Changes of salivary Nicotine and Cotinine Levels from baseline at each e-cigarette condition (3 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 3 (at 70 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yale University
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Suchitra Krishnan-Sarin, PhD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT05932745
    Other Study ID Numbers:
    • 2000035551_b
    • 2U54DA036151-11
    First Posted:
    Jul 6, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Yale University
    Menthol, cooling components, cigarette, e-cigarette, vaping
    Additional relevant MeSH terms:
    Tobacco Use Disorder

    Study Results

    No Results Posted as of Jul 11, 2023