Tobacco UseNCT04009850
Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
A study testing Cigarette Brand Switching and E-cigarette Flavor in people with Tobacco Use, run by Yale University at 1 site in United States.
Trial summary
This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Cigarette Brand Switching and E-cigarette Flavor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- Able to read English
- Cigarette smoker
Who cannot join
- Seeking smoking cessation treatment
- Serious psychiatric or medical condition
- Use of other drugs
- Unable or unwilling to complete study protocol
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.
Read the detailed description
The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.
- Conditions
- Tobacco Use
- Being tested
- Cigarette Brand Switching, E-cigarette Flavor
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette Brand SwitchingOther
Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
E-cigarette FlavorOther
Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
| Study group | Role | What they receive |
|---|---|---|
| Menthol e-cigarette | Experimental | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Receives: Other: Cigarette Brand Switching |
| Tobacco e-cigarette | Experimental | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette Receives: Other: E-cigarette Flavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Cigarettes Smoked
Self-reported total number of cigarettes smoked per day (Timeline Follow Back)
Measured: Week 6
Secondary outcomes (4)
E-cigarette Use
Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)
Measured: Week 6
Tobacco Product Satisfaction
Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction
Measured: Week 6
Motivation to Quit Smoking
Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit
Measured: Week 6
Nicotine Dependence
Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jul 2019
- Primary completion9 Nov 2019
- Study completion31 Jan 2022
Why it stopped: Study enrollment was temporarily paused in 2020 due to COVID-19. Study was closed without further enrollment in 2022.
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 UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Parallel groups
- Model description
- Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Krysten Bold, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009850
- Sponsor's protocol ID
- 2000025572
- Other IDs
- 2U54DA036151-06
- Status last verified
- Feb 2024
- First submitted
- 3 Jul 2019
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
- ClinicalTrials.gov ID
- NCT04009850
- Acronym / sponsor ID
- 2000025572
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment was temporarily paused in 2020 due to COVID-19. Study was closed without further enrollment in 2022.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 9 Nov 2019 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.
Detailed description
The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes
| Arm | Type | Receives |
|---|---|---|
| Menthol e-cigarette | Experimental | Other: Cigarette Brand SwitchingAdult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette |
| Tobacco e-cigarette | Experimental | Other: E-cigarette FlavorAdult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 or older
- Able to read English
- Cigarette smoker
Key exclusion criteria (4 listed)
- Seeking smoking cessation treatment
- Serious psychiatric or medical condition
- Use of other drugs
- Unable or unwilling to complete study protocol
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 |
|---|---|---|
| Cigarette Brand SwitchingAdult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes | Other | Menthol e-cigarette |
| E-cigarette FlavorAdult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes | Other | Tobacco e-cigarette |
Primary outcome
Total Number of Cigarettes Smoked
Time frame: Week 6
Self-reported total number of cigarettes smoked per day (Timeline Follow Back)
4 secondary outcomes
E-cigarette Use
Time frame: Week 6
Tobacco Product Satisfaction
Time frame: Week 6
Motivation to Quit Smoking
Time frame: Week 6
Nicotine Dependence
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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.
Krysten Bold, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarette Brand Switching and E-cigarette Flavor in people with Tobacco Use, run by Yale University 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Mar 2024. 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 17 May 2022). 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?
Total Number of Cigarettes Smoked (time frame: Week 6). 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 8 Mar 2024.