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Effects of E-Cigarette Flavors on Adults TCORS 2.0

NCT ID: NCT03635333

Last Updated: 2025-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-14

Study Completion Date

2023-07-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Nicotine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Low nicotine, tobacco

6 mg nicotine combined with tobacco flavored e-juice

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine level (6 or 18 mg)

Flavor

Intervention Type DRUG

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

Low nicotine, menthol

6 mg nicotine combined with menthol flavored e-juice

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine level (6 or 18 mg)

Flavor

Intervention Type DRUG

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

Low nicotine,cherry

6 mg nicotine combined with cherry flavored e-juice

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine level (6 or 18 mg)

Flavor

Intervention Type DRUG

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

High nicotine, tobacco

18 mg nicotine combined with tobacco flavored e-juice

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine level (6 or 18 mg)

Flavor

Intervention Type DRUG

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

High nicotine, menthol

18 mg nicotine combined with menthol flavored e-juice

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine level (6 or 18 mg)

Flavor

Intervention Type DRUG

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

High Nicotine, cherry

18 mg nicotine combined with cherry flavored e-juice

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine level (6 or 18 mg)

Flavor

Intervention Type DRUG

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

Low Nicotine, Vanilla

6 mg nicotine combined with vanilla flavored e-juice

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine level (6 or 18 mg)

Flavor

Intervention Type DRUG

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

High Nicotine, Vanilla

18 mg nicotine combined with vanilla flavored e-juice

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine level (6 or 18 mg)

Flavor

Intervention Type DRUG

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

Interventions

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Nicotine

Nicotine level (6 or 18 mg)

Intervention Type DRUG

Flavor

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CMHC, Substance Abuse Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2U54DA036151-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000023077-2

Identifier Type: -

Identifier Source: org_study_id