Tobacco Use DisorderNCT02342327
Smoking Cessation in Menthol Flavored Cigarette Smokers
A study testing switch to non-menthol cigarettes prior to cessation attempt and continue smoking menthol cigarettes prior to cessation attempt in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine if in smokers of menthol cigarettes, switching to non-menthol cigarettes prior to a cessation attempt results in greater cessation success than attempting to quit without first switching Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- switch to non-menthol cigarettes prior to cessation attempt and continue smoking menthol cigarettes prior to cessation attempt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2014to 11 Jul 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Self identify as African American
- smoke primarily menthol cigarettes
- be between the ages of 18 and 64
- smoke a minimum number of cigarettes per day
- express an interest in quitting smoking
Who cannot join
- current unstable medical / psychiatric condition
- regular use any form of nicotine or tobacco other than cigarettes
- are pregnant or breast feeding
- The investigators will evaluate if there are other reasons why someone may not be eligible to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, 55455
About this study
The purpose of this study is to determine if in smokers of menthol cigarettes, switching to non-menthol cigarettes prior to a cessation attempt results in greater cessation success than attempting to quit without first switching
- Conditions
- Tobacco Use Disorder
- Being tested
- switch to non-menthol cigarettes prior to cessation attempt, continue smoking menthol cigarettes prior to cessation attempt
- 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.
switch to non-menthol cigarettes prior to cessation attemptOther
continue smoking menthol cigarettes prior to cessation attemptOther
| Study group | Role | What they receive |
|---|---|---|
| Continue smoking menthol cigarettes | Other | Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking Receives: Other: continue smoking menthol cigarettes prior to cessation attempt |
| Switch to non-menthol cigarettes | Other | Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking Receives: Other: switch to non-menthol cigarettes prior to cessation attempt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Lapse
Time from smoking cessation until first lapse (i.e. a cigarette is smoked)
Measured: 6 months
Secondary outcomes (1)
Time to Relapse
Days from the quit attempt until the first of seven consecutive smoking days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start28 Oct 2014
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
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 (2)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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kotlyar, PharmD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342327
- Sponsor's protocol ID
- 1406M51364
- Status last verified
- Apr 2021
- First submitted
- 14 Jan 2015
- Last updated
- 28 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on Smoking Behavior of Switching Menthol Smokers to Non-menthol Cigarettes. Nicotine Tob Res. 2021 Oct 7;23(11):1921-1927. doi: 10.1093/ntr/ntab090.
PubMed 33983396Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on time to lapse of switching menthol smokers to non-menthol cigarettes prior to a cessation attempt: a pilot study. Tob Control. 2021 Sep;30(5):574-577. doi: 10.1136/tobaccocontrol-2020-055689. Epub 2020 Jul 27.
PubMed 32719011
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation in Menthol Flavored Cigarette Smokers
- ClinicalTrials.gov ID
- NCT02342327
- Acronym / sponsor ID
- 1406M51364
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if in smokers of menthol cigarettes, switching to non-menthol cigarettes prior to a cessation attempt results in greater cessation success than attempting to quit without first switching
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue smoking menthol cigarettes | Other | Other: continue smoking menthol cigarettes prior to cessation attemptMenthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking |
| Switch to non-menthol cigarettes | Other | Other: switch to non-menthol cigarettes prior to cessation attemptMenthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Self identify as African American
- smoke primarily menthol cigarettes
- be between the ages of 18 and 64
- smoke a minimum number of cigarettes per day
- express an interest in quitting smoking
Key exclusion criteria (4 listed)
- current unstable medical / psychiatric condition
- regular use any form of nicotine or tobacco other than cigarettes
- are pregnant or breast feeding
- The investigators will evaluate if there are other reasons why someone may not be eligible to participate
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 |
|---|---|---|
| switch to non-menthol cigarettes prior to cessation attempt | Other | Switch to non-menthol cigarettes |
| continue smoking menthol cigarettes prior to cessation attempt | Other | Continue smoking menthol cigarettes |
Primary outcome
Time to Lapse
Time frame: 6 months
Time from smoking cessation until first lapse (i.e. a cigarette is smoked)
1 secondary outcome
Time to Relapse
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33983396Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on Smoking Behavior of Switching Menthol Smokers to Non-menthol Cigarettes. Nicotine Tob Res. 2021 Oct 7;23(11):1921-1927. doi: 10.1093/ntr/ntab090.
- Derived from this study: PubMed 32719011Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on time to lapse of switching menthol smokers to non-menthol cigarettes prior to a cessation attempt: a pilot study. Tob Control. 2021 Sep;30(5):574-577. doi: 10.1136/tobaccocontrol-2020-055689. Epub 2020 Jul 27.
Related trials for Tobacco Use Disorder
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
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.
Michael Kotlyar, PharmD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing switch to non-menthol cigarettes prior to cessation attempt and continue smoking menthol cigarettes prior to cessation attempt 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 5 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: finished, as of the sponsor's last update on 28 Apr 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 28 Apr 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?
Time to Lapse (time frame: 6 months). 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 NCT02342327, which also lists 2 linked publications.
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 28 Apr 2021.