Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

University of Kansas

Status

Completed

Conditions

Tobacco Use Disorder

Treatments

Device: E-cigarette product

Study type

Interventional

Funder types

Other

Identifiers

NCT04996940

145421a

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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