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

Yale University59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Nicotine Dependence, Other Tobacco Product

Interventions

NicotineDRUG

Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Low Dose MentholOTHER

A low dose of menthol will be added to the tobacco flavor.

High Dose MentholOTHER

A high dose of menthol will be added to the tobacco flavor.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CMHC

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: Every 30 min for 120 min during lab session

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: Every 30 min for 120 min during lab session

Data from ClinicalTrials.gov

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