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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2019-02-25

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.

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Detailed Description

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Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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E-cigarette flavor

In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Experimental Flavor

Intervention Type OTHER

Experimental fruit flavored e-cigarette for lab session

Menthol Flavor

In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Menthol Flavor

Intervention Type OTHER

Menthol flavored e-cigarette for lab session

No Flavor

In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.

Group Type PLACEBO_COMPARATOR

Nicotine

Intervention Type DRUG

Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Interventions

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Nicotine

Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

Intervention Type DRUG

Experimental Flavor

Experimental fruit flavored e-cigarette for lab session

Intervention Type OTHER

Menthol Flavor

Menthol flavored e-cigarette for lab session

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes