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OpenTrials
Completed

NCT Number: NCT04378907

Assessing Electronic Cigarette Nicotine Flux

The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.

Completed

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Key information

Conditions

Electronic Cigarette Use Behavior Smoking Vaping

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for the Study of Tobacco Products

Richmond, Virginia, 23298, United States

About this study

Only one arm enrolled.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration

Other

ECIG LAB SESSION: 30 watts, 0 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration

Other

ECIG Lab Session, 30 watts, 6 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration

Other

ECIG Lab Session, 30 watts, 15 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration

Other

ECIG Lab Session, 30 watts, 30 mg/ml nicotine concentration

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

Primary outcomes

  1. Plasma Nicotine Concentration

    Time frame: Before directed bout, after directed bout, prior to ad lib use, after ad lib use, and immediately after own brand use.

    Blood will be taken during each session (5) to examine changes from baseline to immediately follow a ten-puff bout. There is one arm, but 4 different conditions per outcome. One subject with/ missing plasma samples was removed from analysis.

  2. Cigarette/ECIG Challenge Paradigm

    Time frame: Completion of ad lib bout to use of own brand cigarette

    Subjects, following a period of abstinence, they are given a limited time to use either their own brand of cigarette or an e-cigarette. One arm enrolled and the subjects received each of the 4 conditions per outcome.

Secondary outcomes

  1. Puff Volume

    Time frame: During directed bout, during ad lib bout

    Puff volume.

  2. Puff Duration

    Time frame: During directed bout, during ad lib bout

    Puff duration measured in seconds.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 7, 2020
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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