Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)

Study Overview
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Brief Summary
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The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux) among current combustible cigarette users. The investigators will compare abuse liability indices between three FDA-authorized ECIG products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes. The investigators will also test the influence of ECIG flavor availability (tobacco vs. menthol) within three ECIG product classes.

Official Title
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Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)

Conditions
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Electronic Cigarette Use

Intervention / Treatment
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* Other: Tobacco product administration and assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy (determined by self-report) at least 18 years old willing to provide informed consent able to attend the lab and use designated products according to study protocol smoke cigarettes at least 3 days per week and on those days at least 1 cigarette smoked per day positive urine cotinine test Exclusion Criteria: Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening. Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will complete 4, within-subject, laboratory sessions that differ by the product used: 1) own brand cigarette, 2) NJOY Ace 2.4% nicotine ECIG (Menthol and Classic Tobacco flavor), 3) NJOY Ace 5.0% nicotine ECIG (Menthol and Classic Tobacco flavor), and 4) NJOY Daily ECIG 6% nicotine (Menthol and Extra Rich Tobacco). The first condition for all participants will be their own brand cigarette. The subsequent three sessions will be assigned using a Latin-square following enrollment, and within each session participants will sample and evaluate two flavors of each session's product (session flavor order is incorporated into the Latin-square condition order assignment).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Own Brand Cigarette<br> | Other: Tobacco product administration and assessment<br>* Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.<br>|
| Experimental: NJOY Ace 2.4% nicotine ECIG - Menthol flavor<br> | Other: Tobacco product administration and assessment<br>* Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.<br>|
| Experimental: NJOY Ace 2.4% nicotine ECIG - Classic Tobacco flavor<br> | Other: Tobacco product administration and assessment<br>* Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.<br>|
| Experimental: NJOY Ace 5.0% nicotine ECIG - Menthol flavor<br> | Other: Tobacco product administration and assessment<br>* Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.<br>|
| Experimental: NJOY Ace 5.0% nicotine ECIG - Classic Tobacco flavor<br> | Other: Tobacco product administration and assessment<br>* Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.<br>|
| Experimental: NJOY Daily 6.0% nicotine ECIG - Menthol flavor<br> | Other: Tobacco product administration and assessment<br>* Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.<br>|
| Experimental: NJOY Daily 6.0% nicotine ECIG - Extra Rich Tobacco flavor<br> | Other: Tobacco product administration and assessment<br>* Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breakpoint of Drug Purchase Task (DPT) | The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. | Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session | 
| Elasticity of Drug Purchase Task (DPT) | The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. | Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session | 
| Omax of Drug Purchase Task (DPT) | The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. | A DPT will be Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session once for each arm. | 
| Pmax of Drug Purchase Task (DPT) | The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. | Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session | 
| Intensity of Drug Purchase Task (DPT) | The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. | Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session | 
| Cross-price elasticity of the Cross Product-DPT | The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices. | Each CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic Cigarette, Nicotine Flux, Tobacco Use