Tobacco Use DisorderNCT03402243
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
A study testing Menthol ban on cigarettes, Menthol ban on cigarettes and e-cigarettes and No menthol ban in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Menthol ban on cigarettes, Menthol ban on cigarettes and e-cigarettes and No menthol ban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 25 Mar 2020
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18 and 64
- Purchase exclusively menthol cigarettes
- Not currently motivated to quit smoking
- Smoking a minimum number of cigarettes per day
Who cannot join
- Report a serious, unstable medical or psychiatric condition
- Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)
- Have used any smoking cessation therapy during the past month
- Regularly use any form of tobacco other than cigarettes
- Are pregnant or breast feeding or planning to become pregnant or breast feed during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, 55455
About this study
In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.
- Conditions
- Tobacco Use Disorder
- Being tested
- Menthol ban on cigarettes, Menthol ban on cigarettes and e-cigarettes, No menthol ban
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol ban on cigarettesOther
Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
Menthol ban on cigarettes and e-cigarettesOther
Participants will have neither menthol flavored cigarettes or e-cigarettes available
No menthol banOther
Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
| Study group | Role | What they receive |
|---|---|---|
| Menthol ban only for cigarettes | Experimental | Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge Receives: Other: Menthol ban on cigarettes |
| Menthol ban for cigarettes and e-cigarettes | Experimental | Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge Receives: Other: Menthol ban on cigarettes and e-cigarettes |
| No Menthol Ban | Other | Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge Receives: Other: No menthol ban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Tobacco Product Used
Total number of cigarettes smoked and puffs of e-cigarettes used
Measured: 6 weeks
Secondary outcomes (2)
How Much of Each Product is Obtained From the "Experimental Marketplace"
Number of packs of cigarettes obtained and amount of e-liquid obtained from the "experimental marketplace"
Measured: 6 weeks
Motivation to Quit Smoking Cigarettes
Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start26 Feb 2018
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402243
- Sponsor's protocol ID
- R03DA045150
- Other IDs
- R03DA045150
- Status last verified
- Jul 2021
- First submitted
- 9 Jan 2018
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable information will be shared with other researchers
Publications
Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Hatsukami DK. Effect on Tobacco Use and Subjective Measures of Including E-cigarettes in a Simulated Ban of Menthol in Combustible Cigarettes. Nicotine Tob Res. 2022 Aug 6;24(9):1448-1457. doi: 10.1093/ntr/ntac107.
PubMed 35430631
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
- ClinicalTrials.gov ID
- NCT03402243
- Acronym / sponsor ID
- R03DA045150
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menthol ban only for cigarettes | Experimental | Other: Menthol ban on cigarettesParticipants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge |
| Menthol ban for cigarettes and e-cigarettes | Experimental | Other: Menthol ban on cigarettes and e-cigarettesParticipants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge |
| No Menthol Ban | Other | Other: No menthol banParticipants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between the ages of 18 and 64
- Purchase exclusively menthol cigarettes
- Not currently motivated to quit smoking
- Smoking a minimum number of cigarettes per day
Key exclusion criteria (5 listed)
- Report a serious, unstable medical or psychiatric condition
- Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)
- Have used any smoking cessation therapy during the past month
- Regularly use any form of tobacco other than cigarettes
- Are pregnant or breast feeding or planning to become pregnant or breast feed during the study
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 |
|---|---|---|
| Menthol ban on cigarettesParticipants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes | Other | Menthol ban only for cigarettes |
| Menthol ban on cigarettes and e-cigarettesParticipants will have neither menthol flavored cigarettes or e-cigarettes available | Other | Menthol ban for cigarettes and e-cigarettes |
| No menthol banParticipant will have menthol and tobacco flavored cigarettes and e-cigarettes available | Other | No Menthol Ban |
Primary outcome
Amount of Tobacco Product Used
Time frame: 6 weeks
Total number of cigarettes smoked and puffs of e-cigarettes used
2 secondary outcomes
How Much of Each Product is Obtained From the "Experimental Marketplace"
Time frame: 6 weeks
Motivation to Quit Smoking Cigarettes
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35430631Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Hatsukami DK. Effect on Tobacco Use and Subjective Measures of Including E-cigarettes in a Simulated Ban of Menthol in Combustible Cigarettes. Nicotine Tob Res. 2022 Aug 6;24(9):1448-1457. doi: 10.1093/ntr/ntac107.
- Individual participant dataSharing planned: No. No identifiable information will be shared with other researchers
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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 Menthol ban on cigarettes, Menthol ban on cigarettes and e-cigarettes and No menthol ban in people with Tobacco Use Disorder, run by University of Minnesota 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 4 inclusion and 5 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 10 Aug 2021. 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 10 Aug 2021). 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?
Amount of Tobacco Product Used (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402243, which also lists 1 linked publication.
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 10 Aug 2021.