Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

NCT ID: NCT03710590

Last Updated: 2022-10-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-03-09

Brief Summary

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The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.

Detailed Description

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Conditions

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Electronic Cigarettes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

The purpose of this study is to determine differences in nicotine delivery, use behavior (puff topography), carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers and experienced electronic cigarette users use an electronic cigarette with different settings (different voltage and resistance settings, which together determine power levels) and different e-liquid concentrations.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will be blinded to the power level and nicotine concentration used in each session.

Study Groups

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Cigarette smokers

Group Type ACTIVE_COMPARATOR

ECIG Lab Session 15 watts, 10 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

ECIG Lab Session 15 watts, 15 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).

ECIG Lab Session 15 watts, 30 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

ECIG Lab Session 30 watts, 10 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

ECIG Lab Session 30 watts, 15 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

ECIG Lab Session 30 watts, 30 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Electronic cigarette users

Group Type ACTIVE_COMPARATOR

ECIG Lab Session 15 watts, 10 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

ECIG Lab Session 15 watts, 15 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).

ECIG Lab Session 15 watts, 30 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

ECIG Lab Session 30 watts, 10 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

ECIG Lab Session 30 watts, 15 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

ECIG Lab Session 30 watts, 30 mg nicotine

Intervention Type OTHER

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Interventions

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ECIG Lab Session 15 watts, 10 mg nicotine

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Intervention Type OTHER

ECIG Lab Session 15 watts, 15 mg nicotine

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).

Intervention Type OTHER

ECIG Lab Session 15 watts, 30 mg nicotine

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Intervention Type OTHER

ECIG Lab Session 30 watts, 10 mg nicotine

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Intervention Type OTHER

ECIG Lab Session 30 watts, 15 mg nicotine

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Intervention Type OTHER

ECIG Lab Session 30 watts, 30 mg nicotine

During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy (determined by self-report)
* between the ages of 18-55
* willing to provide informed consent
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to 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

18 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: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Clinical Behavioral Pharmacolgy Laboratory

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Eversole A, Budd S, Karaoghlanian N, Lipato T, Eissenberg T, Breland AB. Interactive effects of protonated nicotine concentration and device power on ENDS nicotine delivery, puff topography, and subjective effects. Exp Clin Psychopharmacol. 2023 Apr;31(2):443-454. doi: 10.1037/pha0000576. Epub 2022 Jun 13.

Reference Type DERIVED
PMID: 35696157 (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

HM20012738

Identifier Type: -

Identifier Source: org_study_id

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