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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50DA036151-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Food and Drug Administration (FDA) | FED |
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This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.
The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarette Brand Switching | Experimental | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette Brand Switching | Other | Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Cigarettes Smoked | Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes | Menthol smoking (Week 2), Non-menthol smoking (Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Dependence | Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence. | Week 4 (non-menthol) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krysten Bold, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31685586 | Derived | Bold KW, Jatlow P, Fucito LM, Eid T, Krishnan-Sarin S, O'Malley S. Evaluating the effect of switching to non-menthol cigarettes among current menthol smokers: an empirical study of a potential ban of characterising menthol flavour in cigarettes. Tob Control. 2020 Nov;29(6):624-630. doi: 10.1136/tobaccocontrol-2019-055154. Epub 2019 Nov 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cigarette Brand Switching | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of the 33 participants who were enrolled, four dropped out prior to the intervention phase where they switched from menthol to non-menthol cigarettes, so the final sample for analysis was n=29.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cigarette Brand Switching | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Total Number of Cigarettes Smoked | Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes | Posted | Mean | Standard Deviation | cigarettes per day | Menthol smoking (Week 2), Non-menthol smoking (Week 4) |
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Data were collected while participants were enrolled in the study (duration=4 weeks). Participants were enrolled over a one-year period.
Adverse events were assessed according to clinicaltrials.gov definitions and in accordance with systematic assessment guidelines by the university review board for grading the severity of adverse events.
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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 | Cigarette Brand Switching | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krysten Bold | Yale University | 203-974-7603 | Krysten.bold@yale.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 | Jun 11, 2018 | Mar 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes
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| Quitting Interest |
Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item "how important is quitting smoking to you?" from 1 "not at all" to 10 "extremely". |
| Week 4 (non-menthol) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Nicotine Dependence | Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence. | Posted | Mean | Standard Deviation | score on a scale | Week 4 (non-menthol) |
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| Secondary | Quitting Interest | Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item "how important is quitting smoking to you?" from 1 "not at all" to 10 "extremely". | Posted | Mean | Standard Deviation | units on a scale | Week 4 (non-menthol) |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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