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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continue smoking menthol cigarettes | Other | Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking |
|
| Switch to non-menthol cigarettes | Other | Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| switch to non-menthol cigarettes prior to cessation attempt | Other |
| ||
| continue smoking menthol cigarettes prior to cessation attempt |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Lapse | Time from smoking cessation until first lapse (i.e. a cigarette is smoked) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse | Days from the quit attempt until the first of seven consecutive smoking days | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
The investigators will evaluate if there are other reasons why someone may not be eligible to participate
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kotlyar, PharmD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Sciences Institute | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33983396 | Derived | 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. | |
| 32719011 | Derived | Kotlyar 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continue Smoking Menthol Cigarettes | Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking continue smoking menthol cigarettes prior to cessation attempt |
| FG001 | Switch to Non-menthol Cigarettes | Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking switch to non-menthol cigarettes prior to cessation attempt |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continue Smoking Menthol Cigarettes | Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking continue smoking menthol cigarettes prior to cessation attempt |
| BG001 | Switch to Non-menthol Cigarettes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Lapse | Time from smoking cessation until first lapse (i.e. a cigarette is smoked) | Participants who attended the quit day visit | Posted | Median | 95% Confidence Interval | days | 6 months |
|
For the duration of each participant's participation (up to 7 months for each participant)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continue Smoking Menthol Cigarettes | Menthol cigarette smokers continue to smoke menthol cigarettes for a four week period before attempting to quit smoking continue smoking menthol cigarettes prior to cessation attempt |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kotlyar | University of Minnesota | 612-625-1160 | kotly001@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2017 | Mar 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Other |
|
Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking switch to non-menthol cigarettes prior to cessation attempt |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Time to Relapse | Days from the quit attempt until the first of seven consecutive smoking days | Posted | Median | 95% Confidence Interval | days | 6 months |
|
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|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Switch to Non-menthol Cigarettes | Menthol cigarette smokers switch to non-menthol cigarettes for a four week period before attempting to quit smoking switch to non-menthol cigarettes prior to cessation attempt | 0 | 62 | 0 | 62 | 0 | 62 |
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