Assessing Electronic Cigarette Nicotine Flux

February 2, 2026 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Only one arm enrolled.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alison Breland, PhD
  • Phone Number: (804) 628-2300
  • Email: abbrelan@vcu.edu

Study Contact Backup

  • Name: Thomas Eissenberg, PhD
  • Phone Number: 804-827-3562
  • Email: teissenb@vcu.edu

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Center for the Study of Tobacco Products

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experiemental
Only one arm enrolled. ECIG Lab Session, 30 watts . During each session (intervention) participants will first complete a 10-puff product use bout, and then a 90-minute product use bout.
Other: Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration
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.
Other: Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration
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.
Other: Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration
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.
Other: Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Before directed bout, after directed bout, prior to ad lib use, after ad lib use, and immediately after own brand use.
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.
Completion of ad lib bout to use of own brand cigarette

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Puff Volume
Time Frame: During directed bout, during ad lib bout
Puff volume.
During directed bout, during ad lib bout
Puff Duration
Time Frame: During directed bout, during ad lib bout
Puff duration measured in seconds.
During directed bout, during ad lib bout

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in heart rate
Time Frame: Baseline to 255 minutes
Change in heart rate, measured in beats per minute.
Baseline to 255 minutes
Inter puff interval
Time Frame: Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout.
The time between each puff, in seconds.
Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout.
Flow rate
Time Frame: Flow rate will be measured during the approximately 5-minute, 10-puff use bout.
The rate of air flow during each puff, in ml/second.
Flow rate will be measured during the approximately 5-minute, 10-puff use bout.
Direct Effects of Vaping Questionnaire
Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
This measure is related to the effects of vaping (10 questions, each scored from 0 - 100).
This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
Direct Effects of Nicotine Questionnaire
Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
This measure is related to the side effects of nicotine (10 questions, each scored from 0 - 100).
This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
Hughes-Hatsukami Questionnaire
Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
This measure is related to nicotine abstinence symptoms (11 questions, each scored from 0 - 100).
This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
General Labeled Magnitude Scale
Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
This measure is related to perceptions of electronic cigarette effects (3 questions, each scored from 0 - 100).
This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
Labeled Hedonic Scale
Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.
This measure is related to perceptions of electronic cigarette effects (4 questions, each scored from 0 - 100).
This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alison Breland, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM20018580
  • 5U54DA036105-10 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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