Effects of E-Cigarette Flavors on Adults TCORS 2.0

Yale University130 enrolled

Overview

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

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. As of October 2020, this protocol was updated in which an additional lab session was added. Participants are to complete 4 lab sessions in which they will use an e-cigarette and complete questionnaires. In each individual lab session, they will sample one of the following four e-liquids: cherry, vanilla, menthol, tobacco. Additionally, participant age range was shifted to 21-50 with the younger condition being 21-34 and older being 35-50 and cigarette requirement was at least 1 cigarette/day at this time to be more representative of current persons who smoke.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

130

Conditions

Nicotine Use Disorder

Interventions

NicotineDRUG

Nicotine level (6 or 18 mg)

FlavorDRUG

Flavor of e-juice (tobacco, menthol, cherry, vanilla)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ages 21-34 years or 35 -50 years * Able to read and write * Smoking \>/= 1 cigarettes or cigars/day * Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes * Not seeking treatment to stop smoking 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

Locations (1)

CMHC, Substance Abuse Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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 \[range -100 to 100\] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)

Time frame: Baseline (+10 minutes) to end of lab session (+40 minutes)

Data from ClinicalTrials.gov

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