Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

NCT04996940 | Completed Results FDA Device

• 1 other identifier: 145421a
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

tobacco; e-cigarette

Outcome Measures

Primary Outcomes (1)

• 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? 1. Extremely unlikely 2. Unlikely 3. Neutral 4. Likely 5. 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 Outcomes (3)

• Questionnaire Scale "Subjective Vaping Experience"

  during the intervention

• Questionnaire Scale "Perceptions of Flavor"

  during the intervention

• Questionnaire Scale "Product Demand"

  during the intervention

Study Arms (2)

Tobacco then Menthol

EXPERIMENTAL

A 30-minute session with tobacco flavor then a 30-min session with menthol flavor

Device: E-cigarette product

Menthol then tobacco

EXPERIMENTAL

A 30-minute session with menthol flavor then a 30-min session with tobacco flavor

Device: E-cigarette product

Interventions

E-cigarette product DEVICE

Participants will be randomized 1:1 to e-cigarette flavor order either: 1. tobacco e-cigarette 2. menthol e-cigarette

Menthol then tobacco; Tobacco then Menthol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Results Point of Contact

• Title: Leah Lambart Graduate Research Assistant
• Organization: University of Kansas Medical Center

llambart@kumc.edu

9139457862

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 9, 2021
• Study Start: June 20, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)