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Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids, rather than free-base nicotine solutions that have been used in other ENDS device types. Manufacturers claim that these formulations reduce the harshness of nicotine delivery, while still delivering sufficiently high levels of nicotine. However, the role of nicotine salts in the popularity and use of pod systems remains unclear because no studies have directly manipulated and examined the role of nicotine formulation (salt vs. free base) in reinforcement value and use. The primary purpose of the proposed study is to assess the impact of nicotine formulation (nicotine salt vs. free-base) in reinforcement value and tobacco use. Current smokers (n=30) will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit during which they will sample a traditional cigarette and two ENDS products (nicotine salt ENDS, free base ENDS). All aspects of the device will be held constant other than the nicotine formulation (including nicotine concentration, flavor options, device brand). Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the products they sampled and their own cigarette. Finally, participants will be assigned to take one of the products they sampled home to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free Base Nicotine | Active Comparator | Participants assigned to this group will try both a free base nicotine and a salt base nicotine, and then take home an e-cigarette and free base nicotine e-liquid to sample for one week. |
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| Salt Base Nicotine | Active Comparator | Participants assigned to this group will try both a free base nicotine and a salt base nicotine, and then take home an e-cigarette and salt base nicotine e-liquid to sample for one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salt Base Nicotine | Other | Participants will try both free base and salt base nicotine e-liquid and then take home salt base nicotine |
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| Measure | Description | Time Frame |
|---|---|---|
| Most preferred product | Participants complete a preference assessment in which they choose between the salt liquid, free base liquid, or a traditional cigarette in a series of trials. The outcome of this assessment is the product chosen most often by each participant. | Lab Visit 2, occurring approximately one week after the initial screening/baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes per day | The average number of cigarettes smoked per day during the one week sampling period | Week 2 of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Neither the staff nor the participants will be told whether the e-liquid is free base or salt based.
| Free Base Nicotine | Other | Participants will try both free base and salt base nicotine e-liquid and then take home free base nicotine |
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