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Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-cigarette product
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tobacco Use Disorder focused on measuring tobacco, e-cigarette

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tobacco then Menthol

Menthol then tobacco

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 14, 2021
Last Updated
August 18, 2023
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04996940
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
August 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
tobacco, e-cigarette

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tobacco then Menthol
Arm Type
Experimental
Arm Description
A 30-minute session with tobacco flavor then a 30-min session with menthol flavor
Arm Title
Menthol then tobacco
Arm Type
Experimental
Arm Description
A 30-minute session with menthol flavor then a 30-min session with tobacco flavor
Intervention Type
Device
Intervention Name(s)
E-cigarette product
Intervention Description
Participants will be randomized 1:1 to e-cigarette flavor order either: tobacco e-cigarette menthol e-cigarette
Primary Outcome Measure Information:
Title
Questionnaire Scale "Intentions for Future Use"
Description
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.
Time Frame
during the intervention
Secondary Outcome Measure Information:
Title
Questionnaire Scale "Subjective Vaping Experience"
Description
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.
Time Frame
during the intervention
Title
Questionnaire Scale "Perceptions of Flavor"
Description
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.
Time Frame
during the intervention
Title
Questionnaire Scale "Product Demand"
Description
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.
Time Frame
during the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes

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