The Interaction of Flavor With Nicotine Form in Adult Smokers

NCT ID: NCT04262817

Last Updated: 2023-05-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-02-02

Brief Summary

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This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.

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, participants will receive two experimental e-cigarette flavors

Group Type EXPERIMENTAL

Nicotine form

Intervention Type DRUG

participants will receive 36mg/ml nicotine salt and freebase nicotine

E-cigarette experimental flavor

Intervention Type OTHER

Participants will receive menthol and tobacco flavored e-cigarettes

E-cigarette nicotine form

In this arm, participants will receive two forms of nicotine in an e-cigarette

Group Type EXPERIMENTAL

Nicotine form

Intervention Type DRUG

participants will receive 36mg/ml nicotine salt and freebase nicotine

E-cigarette experimental flavor

Intervention Type OTHER

Participants will receive menthol and tobacco flavored e-cigarettes

Interventions

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Nicotine form

participants will receive 36mg/ml nicotine salt and freebase nicotine

Intervention Type DRUG

E-cigarette experimental flavor

Participants will receive menthol and tobacco flavored e-cigarettes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 21 years old, able to read and write, use of combustible

Exclusion Criteria

\-
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Pierce Laboratory

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

1K01DA051882-01

Identifier Type: NIH

Identifier Source: secondary_id

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2000025687

Identifier Type: -

Identifier Source: org_study_id

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