Effects of E-Cigarette Flavors on Adults TCORS 2.0

Study Overview
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Brief Summary
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This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.

Detailed Description
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This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.

Official Title
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Effects of E-Cigarette Flavors on Adults

Conditions
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Nicotine Use Disorder

Intervention / Treatment
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* Drug: Nicotine
* Drug: Flavor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-24 years or 35 -50 years Able to read and write Smoking > 10 cigarettes or cigars/day Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes Not seeking treatment to stop smoking No regular use of e-cigarettes Exclusion Criteria: Daily use of other drugs including prescribed psychoactive drugs Any significant current medical or psychiatric condition Known hypersensitivity to propylene glycol Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low nicotine, tobacco<br>6 mg nicotine combined with tobacco flavored e-juice | Drug: Nicotine<br>* Nicotine level (6 or 18 mg)<br>Drug: Flavor<br>* Flavor of e-juice (tobacco, menthol, strawberry)<br>|
| Experimental: Low nicotine, menthol<br>6 mg nicotine combined with menthol flavored e-juice | Drug: Nicotine<br>* Nicotine level (6 or 18 mg)<br>Drug: Flavor<br>* Flavor of e-juice (tobacco, menthol, strawberry)<br>|
| Experimental: Low nicotine, strawberry<br>6 mg nicotine combined with strawberry flavored e-juice | Drug: Nicotine<br>* Nicotine level (6 or 18 mg)<br>Drug: Flavor<br>* Flavor of e-juice (tobacco, menthol, strawberry)<br>|
| Experimental: High nicotine, tobacco<br>18 mg nicotine combined with tobacco flavored e-juice | Drug: Nicotine<br>* Nicotine level (6 or 18 mg)<br>Drug: Flavor<br>* Flavor of e-juice (tobacco, menthol, strawberry)<br>|
| Experimental: High nicotine, menthol<br>18 mg nicotine combined with menthol flavored e-juice | Drug: Nicotine<br>* Nicotine level (6 or 18 mg)<br>Drug: Flavor<br>* Flavor of e-juice (tobacco, menthol, strawberry)<br>|
| Experimental: Hign Nicotine, strawberry<br>18 mg nicotine combined with strawberry flavored e-juice | Drug: Nicotine<br>* Nicotine level (6 or 18 mg)<br>Drug: Flavor<br>* Flavor of e-juice (tobacco, menthol, strawberry)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score in liking/wanting of e-cigarette | The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking) | Baseline (+10 minutes) to end of lab session (+40 minutes) |