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The Effect of Electronic Cigarette Liquid Characteristics in Smokers.

NCT ID: NCT03861078

Last Updated: 2022-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2021-12-13

Brief Summary

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The purpose of this study is to determine differences in nicotine delivery, user behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of cigarettes.

Detailed Description

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Conditions

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Electronic Cigarettes

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cigarette smokers

Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.

Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened

Group Type EXPERIMENTAL

Own Brand Cigarette

Intervention Type OTHER

Effects of own brand cigarette use.

ECIG 15 mg nicotine, sweetened

Intervention Type OTHER

Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid

ECIG 15 mg nicotine, unsweet

Intervention Type OTHER

Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid

ECIG 0 mg nicotine, sweetened

Intervention Type OTHER

Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid

ECIG 0 mg nicotine, unsweet

Intervention Type OTHER

Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid

Interventions

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Own Brand Cigarette

Effects of own brand cigarette use.

Intervention Type OTHER

ECIG 15 mg nicotine, sweetened

Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid

Intervention Type OTHER

ECIG 15 mg nicotine, unsweet

Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid

Intervention Type OTHER

ECIG 0 mg nicotine, sweetened

Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid

Intervention Type OTHER

ECIG 0 mg nicotine, unsweet

Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy (determined by self-report)
* Between the ages of 21-55 years old
* Current cigarette smokers
* Wiling to provide informed consent
* Able to attend the lab session and abstain from tobacco/nicotine products as required
* Agree to use designated products according to the study protocol

Exclusion Criteria

* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Individuals who weigh less than 110 pounds.

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison Breland, PhD

Role: STUDY_DIRECTOR

Virginia Commonwealth University

Locations

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Clinical Behavioral Pharmacology Laboratory

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Maloney SF, Hoetger C, Bono RS, Lester Scholtes R, Combs M, Karaoghlanian N, Lipato T, Breland A, Eissenberg T. Assessment of human abuse potential of an unflavored, sucralose-sweetened electronic cigarette in combustible cigarette smokers. Exp Clin Psychopharmacol. 2024 Oct;32(5):588-603. doi: 10.1037/pha0000720. Epub 2024 May 30.

Reference Type DERIVED
PMID: 38815111 (View on PubMed)

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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U54DA036105

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F31DA047018

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20015258

Identifier Type: -

Identifier Source: org_study_id