Tobacco Use DisorderNCT04996940
Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes
A study testing E-cigarette product in people with Tobacco Use Disorder, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- E-cigarette product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2021to 15 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Missouri, 66160
About this study
Official title: Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes Among Menthol Cigarette Smokers
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.
Read the 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
- Being tested
- E-cigarette product
- Keywords
- tobacco, e-cigarette
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarette productDevice
Participants will be randomized 1:1 to e-cigarette flavor order either:
- tobacco e-cigarette
- menthol e-cigarette
| Study group | Role | What they receive |
|---|---|---|
| Tobacco then Menthol | Experimental | A 30-minute session with tobacco flavor then a 30-min session with menthol flavor Receives: Device: E-cigarette product |
| Menthol then tobacco | Experimental | A 30-minute session with menthol flavor then a 30-min session with tobacco flavor Receives: Device: E-cigarette product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the intervention
Secondary outcomes (3)
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.
Measured: during the intervention
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.
Measured: during the intervention
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.
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start20 Jun 2021
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996940
- Sponsor's protocol ID
- 145421a
- Status last verified
- Aug 2023
- First submitted
- 14 Jul 2021
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes Among Menthol Cigarette Smokers
- ClinicalTrials.gov ID
- NCT04996940
- Acronym / sponsor ID
- 145421a
- Conditions
- Tobacco Use Disorder
- Keywords
- tobacco, e-cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tobacco then Menthol | Experimental | Device: E-cigarette productA 30-minute session with tobacco flavor then a 30-min session with menthol flavor |
| Menthol then tobacco | Experimental | Device: E-cigarette productA 30-minute session with menthol flavor then a 30-min session with tobacco flavor |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigarette productParticipants will be randomized 1:1 to e-cigarette flavor order either: 1. tobacco e-cigarette 2. menthol e-cigarette | Device | Menthol then tobacco, Tobacco then Menthol |
Primary outcome
Questionnaire Scale "Intentions for Future Use"
Time frame: during the intervention
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.
3 secondary outcomes
Questionnaire Scale "Subjective Vaping Experience"
Time frame: during the intervention
Questionnaire Scale "Perceptions of Flavor"
Time frame: during the intervention
Questionnaire Scale "Product Demand"
Time frame: during the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette product in people with Tobacco Use Disorder, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Scale "Intentions for Future Use" (time frame: during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.