Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

NCT ID: NCT04996940

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-20
• Study Completion Date: 2021-08-15

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tobacco then Menthol

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

Group Type: EXPERIMENTAL

E-cigarette product

Intervention Type: DEVICE

Participants will be randomized 1:1 to e-cigarette flavor order either:

1. tobacco e-cigarette

2. menthol e-cigarette

Menthol then tobacco

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

Group Type: EXPERIMENTAL

E-cigarette product

Intervention Type: DEVICE

Participants will be randomized 1:1 to e-cigarette flavor order either:

1. tobacco e-cigarette

2. menthol e-cigarette

Interventions

E-cigarette product

Participants will be randomized 1:1 to e-cigarette flavor order either:

1. tobacco e-cigarette

2. menthol e-cigarette

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Kansas Medical Center

Kansas City, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

145421a

Identifier Type: -

Identifier Source: org_study_id