The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers

NCT ID: NCT03186911

Last Updated: 2019-08-05

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2019-09-30

Brief Summary

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Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Participants will then sample two e-liquids that vary in nicotine content from little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the subjective effects of each one. Participants will then complete a preference assessment where they choose between the two e-liquids. Participants will be blind to the nicotine contents.

Detailed Description

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Conditions

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Tobacco Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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E-liquid Group

Participants will sample two different e-liquids.

Group Type OTHER

E-liquid sampling and preference assessment

Intervention Type BEHAVIORAL

Participants will sample two different e-liquids that vary in nicotine content, complete questionnaires about each one, and then choose between the two e-liquids in a preference assessment task.

Interventions

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E-liquid sampling and preference assessment

Participants will sample two different e-liquids that vary in nicotine content, complete questionnaires about each one, and then choose between the two e-liquids in a preference assessment task.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old
* Daily cigarette smoking
* Have tried vaping devices on a minimum of one lifetime occasion

Exclusion Criteria

* Unwilling to use a vaping device during the session
* Break alcohol level \> 0.01 (g/dL)
* Pregnant, trying to become pregnant, or breastfeeding
* Systolic BP greater than or equal to 160 mm/Hg or below 90 mm/Hg
* Diastolic BP greater than or equal to 100 mm/Hg or below 50 mm/Hg
* Heart rate greater than or equal to 105 bpm or lower than 45 bpm
* A current upper respiratory infection, recent cardiac event (in the last year), Buerger disease, irregular heartbeat or arrhythmia within the last year, previous allergic or adverse reaction to nicotine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric C Donny, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

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1U54DA031659-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U54 DA031659-06 Pilot

Identifier Type: -

Identifier Source: org_study_id

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