Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Device: E-cigarette product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tobacco then Menthol<br>A 30-minute session with tobacco flavor then a 30-min session with menthol flavor | Device: E-cigarette product<br>* Participants will be randomized 1:1 to e-cigarette flavor order either: tobacco e-cigarette menthol e-cigarette<br>|
| Experimental: Menthol then tobacco<br>A 30-minute session with menthol flavor then a 30-min session with tobacco flavor | Device: E-cigarette product<br>* Participants will be randomized 1:1 to e-cigarette flavor order either: tobacco e-cigarette menthol e-cigarette<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire Scale Intentions for Future Use | 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. | during the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire Scale Subjective Vaping Experience | 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. | during the intervention | 
| Questionnaire Scale Perceptions of Flavor | 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. | during the intervention | 
| Questionnaire Scale Product Demand | 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. | during the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, e-cigarette