Clinical trial NCT04996940: Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes
Official title: Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes Among Menthol Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: tobacco
e-cigarette
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire Scale "Intentions for Future Use"
timeFrame: during the intervention
Secondary outcomes:
measure: Questionnaire Scale "Subjective Vaping Experience"
timeFrame: during the intervention
measure: Questionnaire Scale "Perceptions of Flavor"
timeFrame: during the intervention
measure: Questionnaire Scale "Product Demand"
timeFrame: during the intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Missouri
Study officials:
References: