The Interaction of Flavor With Nicotine Form in Adult Smokers

Study Overview
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Brief Summary
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This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.

Official Title
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The Interaction of Flavor With Nicotine Form in Adult Smokers

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Nicotine form
* Other: E-cigarette experimental flavor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years old, able to read and write, use of combustible Exclusion 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cigarette flavor<br>In this arm, participants will receive two experimental e-cigarette flavors | Drug: Nicotine form<br>* participants will receive 36mg/ml nicotine salt and freebase nicotine<br>Other: E-cigarette experimental flavor<br>* Participants will receive menthol and tobacco flavored e-cigarettes<br>|
| Experimental: E-cigarette nicotine form<br>In this arm, participants will receive two forms of nicotine in an e-cigarette | Drug: Nicotine form<br>* participants will receive 36mg/ml nicotine salt and freebase nicotine<br>Other: E-cigarette experimental flavor<br>* Participants will receive menthol and tobacco flavored e-cigarettes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Liking of E-cigarette Overall | Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with Neither Liked nor Disliked at the midpoint. | up to 3 weeks | 
| Changes in Liking of E-cigarette Flavor | Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with Neither Liked nor Disliked at the midpoint. | up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gLMS: Sweetness | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) right now on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: no sensation, barely detectable, weak, moderate, strong, very strong, and strongest imaginable, positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). | up to 3 weeks | 
| gLMS: Coolness | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) right now on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: no sensation, barely detectable, weak, moderate, strong, very strong, and strongest imaginable, positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). | up to 3 weeks | 
| gLMS: Irritation | Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) right now on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: no sensation, barely detectable, weak, moderate, strong, very strong, and strongest imaginable, positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness). | up to 3 weeks | 
| Number of Puffs | The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed. | up to 3 weeks |