Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1

Study Overview
=================
Brief Summary
-----------------
This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.

Official Title
-----------------
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1

Conditions
-----------------
Nicotine Dependence, Other Tobacco Product

Intervention / Treatment
-----------------
* Drug: Nicotine
* Other: Low Dose Menthol
* Other: High Dose Menthol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-20 years Able to read and write Cigarette smoker Use of e-cigarettes in the past 30 days 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
-----------------
Minimum Age: 18 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Tobacco Flavor<br>In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. | Other: Low Dose Menthol<br>* A low dose of menthol will be added to the tobacco flavor.<br>Other: High Dose Menthol<br>* A high dose of menthol will be added to the tobacco flavor.<br>|
| Active Comparator: Low Dose Nicotine<br>In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. | Drug: Nicotine<br>* Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)<br>Other: Low Dose Menthol<br>* A low dose of menthol will be added to the tobacco flavor.<br>Other: High Dose Menthol<br>* A high dose of menthol will be added to the tobacco flavor.<br>|
| Active Comparator: High Dose Nicotine<br>In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. | Drug: Nicotine<br>* Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)<br>Other: Low Dose Menthol<br>* A low dose of menthol will be added to the tobacco flavor.<br>Other: High Dose Menthol<br>* A high dose of menthol will be added to the tobacco flavor.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liking/effect score of the e-cigarette | The Drug Effects Questionnaire (Soria et al) will be used to ask about participants' liking/effect of the e-cigarettes smoked during the 4 bouts of e-cigarette puffing during the lab session to determine which menthol dose is most preferred. A linear mixed-effects regression model wil be used with nicotine group (none, low, high) as between-subject factor, and menthol dose (none, low dose, high dose) as within-subject factor. | Every 30 min for 120 min during lab session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum value of money at which the e-cigarette is chosen over money | E-cigarette value will be determined using the Multiple Choice Procedure (Griffiths et al, 1993) to determine the reinforcing value of the e-cigarette. The MCP involves sampling the e-cigarette and then making a discrete choice between the e-cigarette or a series of monetary values. | Every 30 min for 120 min during lab session | 
| Change scores from baseline in Nicotine Withdrawal | The Minnesota Nicotine Withdrawal Scale (Hughes et al,1986) will be used to assess the magnitude of change in nicotine withdrawal symptoms during the lab session | Every 30 min for 120 min during lab session | 
| Change scores from baseline 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 | Every 30 min for 120 min during lab session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tobacco, electronic cigarettes, menthol, flavors