Developing E-liquid Product Standards (Sweet Spot Study)

Study Overview
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Brief Summary
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The Sweet Spot Study aims to evaluate the effect of e-liquids with nicotine varying in freebase (FB) levels and concentrations on the appeal of electronic cigarettes (ECs) in young adult EC users with minimal/no history of smoking and older adult smokers.

Official Title
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Nicotine Concentration and Forms: Differential Appeal to Smokers Versus Non-Smokers

Conditions
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Nicotine, Nicotine Vaping, E-cigarette Use

Intervention / Treatment
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* Behavioral: Vaping study EC A
* Behavioral: Vaping study EC B
* Behavioral: Vaping study EC C
* Behavioral: Vaping study EC D
* Behavioral: Vaping study EC E
* Behavioral: Vaping study EC F
* Behavioral: Vaping study EC G
* Behavioral: Vaping study EC H
* Behavioral: Vaping study EC I
* Behavioral: Vaping study EC J


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Young adult e-cigarette user or older adult smoker Willing to abstain from all nicotine product use for 12 hours prior to the study visit Read and speak English Exclusion criteria: Currently attempting to quit nicotine products Currently pregnant, planning to become pregnant, or breastfeeding Current or past use of tobacco products other than e-cigarettes or cigarettes Self-reported diagnosis of lung disease Self-reported new or unstable cardiovascular disease

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Young adult EC users<br>Young Adult EC users | Behavioral: Vaping study EC A<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC B<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC C<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC D<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC E<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC F<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC G<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC H<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC I<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC J<br>* Vaping two puffs using the study EC device<br>|
| Active Comparator: Older adult smokers<br>Adult smokers | Behavioral: Vaping study EC A<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC B<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC C<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC D<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC E<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC F<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC G<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC H<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC I<br>* Vaping two puffs using the study EC device<br>Behavioral: Vaping study EC J<br>* Vaping two puffs using the study EC device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Intentions for continued use | The self-report measure on a 7-point scale will be completed following e-cigarette self-administration. | 1 hour | 
| Intensity of sensory attributes | The 5-item self-report measure will be completed following e-cigarette self-administration, using the general Labeled Magnitude Scale. | 1 hour | 
| Degree of liking or disliking of sensations | The self-report measure will be completed following e-cigarette self-administration, using the Labeled Hedonic Scale. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Appeal | The 11-item modified Cigarette Evaluation Questionnaire (mCEQ) will be completed following e-cigarette self-administration. | 1 hour |