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Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Participants who were unable to fully switch will either be asked to increase the nicotine strength of their pouches or to use a nicotine patch along with pouches. The goal of the study is to see whether these strategies are feasible, acceptable, and helpful, and to inform the design of larger future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Increase | Active Comparator | Increase nicotine content of pouches |
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| Augment | Active Comparator | Add nicotine replacement therapy |
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| Continue | No Intervention | Participants will continue with their treatment from the parent trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine replacement therapy patches | Drug | Nicotine replacement therapy patches will be dosed based on current cigarette smoking at the end of the parent trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Feasibility endpoints include 1) the proportion of eligible subjects who subsequently enroll; 2) the proportion of enrolled subjects who complete the Day 28 and Day 56 assessments; and 3) the proportion of enrolled subjects who complete ≥80% of their daily surveys during the switching period. | Days 1-56 |
| Acceptability | Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM). This measure includes 4 items rated on scale of 1 to 5. Scores are created by averaging responses, with values ranging from 1 to 5. Higher values indicate higher acceptability. | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Palmer, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Universtiy of South Carolina | Charleston | South Carolina | 29425 | United States |
Data from this study may be shared, by reasonable request, with other investigators not affiliated with the tobacco industry.
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Oral nicotine pouches | Drug | Zyn oral nicotine pouches will be provided in the flavor preference of the participant and dosed based on their randomization in the parent trial and randomization in the extension study. |
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