Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04996940
• Other study ID #: 145421a
• Status: Completed
• Phase: N/A
• Start date: June 20, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: August 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Device:
• E-cigarette product
Participants will be randomized 1:1 to e-cigarette flavor order either: tobacco e-cigarette menthol e-cigarette

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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