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Completed

NCT Number: NCT04996940

Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

The study is a randomized crossover trial. Current menthol smokers will complete a session with each flavor of an electronic cigarette: menthol and tobacco. The objective of this survey is to assess for flavor preference.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

About this study

Participants who report typically smoking menthol cigarettes will be invited to complete a session. Participants will undergo overnight tobacco/nicotine abstinence before the visit (eCO<12ppm). Participants will then be randomized 1:1 to e-cigarette flavor order (tobacco e-cigarette, menthol e-cigarette). They will complete a 30-minute ad libitum session with the first product, based on randomization, followed by a 1.5 hour standard washout period, followed by a 30-minute ad libitum vaping session with the second product. Throughout each session, puff topography will be measured via a pressure sensor attached to the e-cigarette device. Participants will complete self-report measures of smoking urges and withdrawal symptoms pre- and post-vaping session. In addition, they will complete measures of subjective vaping experience, perceptions of flavor, product demand, and intentions for future use.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • typically smoking menthol cigarettes
  • Non-Hispanic African American or white/Caucasian,
  • ≥21 years old, smoke 5-30 cigarettes per day,
  • daily cigarette smoker
  • smoked at current rate for at least 6 months
  • interested in trying e-cigarettes
  • not interested in or unable/unwilling to quit cigarette smoking
  • willing to complete one in-person study visits

Exclusion criteria

  • Interested in quitting cigarettes in the next 30 days
  • use of smoking cessation pharmacotherapy in the past 30 days
  • use of non-cigarette tobacco products in the past 30 days
  • use of e-cigarettes >5x in lifetime
  • use of e-cigarettes ≥4 of the past 30 days
  • weight < 110 lbs
  • uncontrolled hypertension (systolic BP ≥ 180 or diastolic BP ≥ 105)
  • pregnant, plans to become pregnant, or breastfeeding
  • live >10 miles from study site (Fairway CRU)
  • current enrollment is a research study or program that aims to alter tobacco use

Treatment and study plan

E-cigarette product

Device

Participants will be randomized 1:1 to e-cigarette flavor order either:

  • tobacco e-cigarette
  • menthol e-cigarette

Primary outcomes

  1. Questionnaire Scale "Intentions for Future Use"

    Time frame: during the intervention

    Using the questionnaire scale "Intentions for Future Use" How much each participant intends to use the products in the future.

    Scale: "Think about the product you just used. If this was the only flavor available, how likely would you be to try this flavor again?

    • Extremely unlikely
    • Unlikely
    • Neutral
    • Likely
    • Extremely likely The range of observed responses from participants for both groups was 1-5. Not all participants completed all study measures so the number of respondents is lower than enrolled.

Secondary outcomes

  1. Questionnaire Scale "Subjective Vaping Experience"

    Time frame: during the intervention

    Please indicate how you are feeling right now on a scale from 0 to 100 where 0 is not at all and 100 is extremely.

    How pleasant would the e-cigarette be to use right now? The observed range of responses from participants for both arms was 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled.

  2. Questionnaire Scale "Perceptions of Flavor"

    Time frame: during the intervention

    On a scale from 0 to 100 where 0 is not at all and 100 is extremely, to what extent did you like the flavor you just used? The observed range of responses from participants in both arms was from 0 to 100.

    Not all participants completed all study measures so the number of respondents is lower than enrolled.

  3. Questionnaire Scale "Product Demand"

    Time frame: during the intervention

    On a scale from 0 to 100 where 0 is not at all and 100 is extremely, how willing would you be to use the flavor you just used again in the future? The observed range of responses from participants in both arms was from 0 to 100.

    Not all participants completed all study measures so the number of respondents is lower than enrolled.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes Among Menthol Cigarette Smokers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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