Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

Study Overview
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Brief Summary
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This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. The hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.

Official Title
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Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Nicotine
* Other: Experimental Flavor
* Other: Menthol Flavor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-20 years Able to read and write Urine cotinine levels of >250 ng/ml at screening appointment Use of e-cigarettes in the past month May or may not currently smoke traditional cigarettes Exclusion Criteria: Seeking smoking cessation treatment Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants Current or past history of psychosis or other psychiatric diagnosis such as major depression Any significant current medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 20 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, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine. | Drug: Nicotine<br>* Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)<br>Other: Experimental Flavor<br>* Experimental fruit flavored e-cigarette for lab session<br>|
| Experimental: Menthol Flavor<br>In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine. | Drug: Nicotine<br>* Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)<br>Other: Menthol Flavor<br>* Menthol flavored e-cigarette for lab session<br>|
| Placebo Comparator: No Flavor<br>In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine. | Drug: Nicotine<br>* Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)<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 the e-cigarette | The Drug Effects Questionnaire (Soria et al) will be used to ask about liking and wanting during the lab session | Baseline (+10 minutes) to end of lab session (+40 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score in rating of coolness | gMLS rating of e-cigarette coolness | Baseline (+10 minutes) to end of lab session (+40 minutes) | 
| Change score in rating of harshness/irritation | gMLS rating of e-cigarette harshness/irritation | Baseline (+10 minutes) to end of lab session (+40 minutes) | 
| Change score in rating of sweetness | gMLS rating of e-cigarette sweetness | Baseline (+10 minutes) to end of lab session (+40 minutes) | 
| Change score in rating of sourness | gMLS rating of e-cigarette sourness | End of lab session (+40 minutes) | 
| Change score in rating of fruitiness | gMLS rating of e-cigarette fruitiness | Baseline (+10 minutes) to end of lab session (+40 minutes) | 
| Change score in rating of total sensation | gMLS rating of e-cigarette total sensation | Baseline (+10 minutes) to end of lab session (+40 minutes) | 
| E-cigarette value | Value of e-cigarette as determined by the Multiple Choice Questionnaire (MCP) task | Baseline (+10 minutes) to end of lab session (+40 minutes) | 
| Number of puffs | Number of puffs taken at the end of the ad-lib vaping period | End of ad-lib lab session 4 (+40 minutes) | 
| Change score in Tobacco Craving | The Brief Questionnaire on Smoking Urges (Tiffany & Drobes,1991) will be used to assess the magnitude of change in tobacco craving during the lab session | Baseline (+10 minutes) to end of lab session (+40 minutes) |