Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2

Study Overview
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Brief Summary
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The purpose of the study is to evaluate how limiting the nicotine content in regular cigarettes affects choices for regular cigarette and e-cigarette products. Eligible participants will be of legal age to purchase tobacco products and regularly use both e-cigarettes and regular cigarettes.

Detailed Description
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Participants in this study will undergo an in-person screening session where the study will be explained in detail and participants will answer questions and provide a breath sample. During the screening session, participants will also be asked to complete surveys. Eligible participants will then complete the training procedures during which they will select an e-cigarette device to use for future preference sessions. During the 4 preference sessions, participants will sample puffs from an e-cigarette and regular cigarette and answer questions about their experience with each. They will also complete a task during which they can choose to earn puffs from the e-cigarette or regular cigarette, or choose to not take any puffs. The 4 sessions will be the same except that a different combination of e-cigarette and regular cigarette is used at each session.

Official Title
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Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2

Conditions
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Smoking, Smoking, Cigarette, E-Cig Use, Nicotine Dependence

Intervention / Treatment
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* Other: very low nicotine content cigarettes
* Other: normal nicotine content cigarettes
* Other: Study e-cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Legal age to purchase tobacco products; Regular user of EC and CC; Owns the e-cigarette device used most often; Agrees to abstain from using all tobacco products for 12 hours prior to each experimental session; Self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid Exclusion Criteria: Unstable medical conditions as determined by the licensed medical professional; Unstable psychiatric conditions as determined by the licensed medical professional or PI; Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy; Serious quit attempt of either or both products in the past 3 months resulting in >30 days of abstinence; Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide; Plans to quit use of either EC or CC, or all tobacco products in the next 45 days; Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid; Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once): Systolic blood pressure (BP) greater than or equal to 160 mm/hg Diastolic BP greater than or equal to 100 mm/hg Heart rate greater than or equal to 115 bpm; Allergy to propylene glycol or vegetable glycerin; Previous adverse reaction when using vaping device or e-liquid; Current or recent alcohol or drug abuse problems; Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months; Literate and able to independently complete and comprehend the consent form and other written study materials and measures.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will complete 4 experimental sessions. At each session, they will receive a different combination of e-cigarette and combusted cigarette.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study EC + UB CC<br>Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC) | Other: Study e-cigarette<br>* E-cigarette provided by study<br>|
| Active Comparator: Study EC + NNC CC<br>Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC | Other: normal nicotine content cigarettes<br>* Investigational combusted cigarettes with normal nicotine content<br>* Other names: NNC;Other: Study e-cigarette<br>* E-cigarette provided by study<br>|
| Experimental: Study EC + VLNC CC<br>Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC | Other: very low nicotine content cigarettes<br>* Investigational combusted cigarettes with very low nicotine content<br>* Other names: VLNC;Other: Study e-cigarette<br>* E-cigarette provided by study<br>|
| No Intervention: Own EC + UB CC<br>Participants will make choices between their own EC device with their own tobacco flavor and their UB CC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of choices for CC during preference task | Participants will complete a preference task during which they will choose to take puffs from the session EC, the session CC, or to abstain from taking any puffs. A total of 10 trials will be completed. The number of choices for CC will be compared across the preference sessions. | during preference session, approximately 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of choices for EC during preference task | Participants will complete a preference task. The number of choices for EC will be compared across the preference sessions. | during preference session, approximately 2 hours | 
| Number of choices to abstain during preference task | Participants will complete a preference task. The number of choices to abstain from any puffs will be compared across the preference sessions. | during preference session, approximately 2 hours | 
| Cigarette Evaluation Scale | subjective reactions (e.g., satisfaction, dizziness) to CC product as well as how much a measure of how much they would pay for a day's worth of the product. Scale is administered on a 0-100 scale where 0 is not at all and 100 is extremely | during preference session, approximately 2 hours | 
| Perceived health risk | Participants will rate on a scale from 1 (very low risk) to 7 (very high risk) their perceived risk of developing a variety of health conditions (e.g., lung cancer, heart disease, stroke) as a result of using each product. | during preference session, approximately 2 hours | 
| Craving | craving rating on a scale from 1-10 [no urge to extremely strong urge] for CC and EC after product exposure relative to baseline value | during preference session, approximately 2 hours | 
| Product Valuation | Participants will be asked how many days per month would they use the CC product they just sampled at a variety of price increments | during preference session, approximately 2 hours | 
| CO boost | Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value | during preference session, approximately 2 hours | 
| Cross Price Elasticity | the change in demand for the session CC in response to a change in price of the session EC | during preference session, approximately 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Reduction, Dual users