Salt-Based E-cigarette

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Non-Cigarette Tobacco Product Formulation on Reinforcement Value and Use in Current Smokers

Conditions
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Smoking, Tobacco Use

Intervention / Treatment
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* Other: Salt Base Nicotine
* Other: Free Base Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: daily cigarette smoker interested in using non-cigarette tobacco product have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion). Exclusion Criteria: additional tobacco use criteria additional medical criteria

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free Base Nicotine<br>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. | Other: Free Base Nicotine<br>* Participants will try both free base and salt base nicotine e-liquid and then take home free base nicotine<br>|
| Active Comparator: Salt Base Nicotine<br>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. | Other: Salt Base Nicotine<br>* Participants will try both free base and salt base nicotine e-liquid and then take home salt base nicotine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |