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Study determined to be not feasible at this time due to limited availability of study product and limited availability of study products in the marketplace.
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The goal of this pilot project is to explore the feasibility of a real-world marketplace study design examining the effects of a reduced nicotine product standard for cigarettes on smoking in the context of a flavor restriction vs. no restriction on e-cigarettes in smokers switched to very low nicotine content cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLNC cigarettes plus access to tobacco and non-tobacco flavored e-cigarettes | Experimental | Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention |
|
| VLNC cigarettes plus access to only tobacco flavored e-cigarettes | Experimental | Smokers who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Participants will then be randomly assigned to a 4-week intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco and non-tobacco e-cigarettes | Other | Participants with no e-cigarette restrictions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants that drop-out by 4 week visit | Percent of participants that drop-out by 4 week visit | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean cigarettes per day (CPD) | Change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 4 visits | Baseline to 4 weeks |
| Number of participants experiencing smoke free days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Tobacco only e-cigarettes | Other | Participants restricted to tobacco flavored e-cigarettes only. |
|
| 4 weeks |