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| ID | Type | Description | Link |
|---|---|---|---|
| R03DA045150 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menthol ban on cigarettes | Other | Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Tobacco Product Used | Total number of cigarettes smoked and puffs of e-cigarettes used | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 6 weeks |
| Motivation to Quit Smoking Cigarettes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Sciences Institute | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35430631 | Derived | 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. |
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No identifiable information will be shared with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Menthol Ban Only for Cigarettes | 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 Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes |
| FG001 | Menthol Ban for Cigarettes and E-cigarettes | 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 Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available |
| FG002 | No Menthol Ban | 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 No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Menthol Ban Only for Cigarettes | 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 Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only 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 | Amount of Tobacco Product Used | Total number of cigarettes smoked and puffs of e-cigarettes used | Posted | Mean | Standard Deviation | tobacco products use per day | 6 weeks |
|
For the duration of each participant's participation (up to 6 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
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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 | Menthol Ban Only for Cigarettes | 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 Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| throat irritation / cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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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 | Jan 16, 2020 | Jun 16, 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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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Menthol ban on cigarettes and e-cigarettes | Other | Participants will have neither menthol flavored cigarettes or e-cigarettes available |
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| No menthol ban | Other | Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available |
|
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
| 6 weeks |
| BG001 | Menthol Ban for Cigarettes and E-cigarettes | 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 Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available |
| BG002 | No Menthol Ban | 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 No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | No Menthol Ban | 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 No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available |
|
|
|
| Secondary | 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" | Posted | Mean | Standard Deviation | units of tobacco | 6 weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Menthol Ban for Cigarettes and E-cigarettes | 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 Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available | 0 | 15 | 0 | 15 | 2 | 15 |
| EG002 | No Menthol Ban | 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 No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available | 0 | 16 | 0 | 16 | 0 | 16 |
| pain / discomfort during inhalation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Mixed Models Analysis |
| 0.076 |
| Superiority |