Electronic Cigarette UseNCT04378907

Assessing Electronic Cigarette Nicotine Flux

A study testing Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration, Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration and Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration in people with Electronic Cigarette Use, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Electronic Cigarette Use
What is being tested?: Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration, Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration and Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 5 Jan 2021to 1 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for the Study of Tobacco Products
Richmond, Virginia, 23298

Other trials in United States

About this study

Read the detailed description

Only one arm enrolled.

Conditions: Electronic Cigarette Use
Being tested: Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration, Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration, Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration, Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration
Medical subject headings: Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentrationOther
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 concentrationOther
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 concentrationOther
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 concentrationOther
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.

Study groups in NCT04378907
Study group	Role	What they receive
Experiemental	Experimental	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. Receives: Other: Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration; Other: Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration; Other: Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration; Other: Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Nicotine Concentration
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.
Measured: 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
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.
Measured: Completion of ad lib bout to use of own brand cigarette

Secondary outcomes (2)

Puff Volume
Puff volume.
Measured: During directed bout, during ad lib bout
Puff Duration
Puff duration measured in seconds.
Measured: During directed bout, during ad lib bout

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 20211 Feb 2023

First posted7 May 2020
Study start5 Jan 2021
Primary completion1 Feb 2023
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations. Only one arm enrolled.
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04378907
Sponsor's protocol ID: HM20018580
Other IDs: 5U54DA036105-10
Status last verified: Feb 2026
First submitted: 30 Apr 2020
Last updated: 4 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Electronic Cigarette Use trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing Electronic Cigarette Nicotine Flux
ClinicalTrials.gov ID: NCT04378907
Acronym / sponsor ID: HM20018580
Conditions: Electronic Cigarette Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 5 Jan 2021 (actual)
Primary completion: 1 Feb 2023 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 7 May 2020 (actual)
Results: Posted 4 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Only one arm enrolled.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations. Only one arm enrolled.

Arm	Type	Receives
Experiemental	Experimental	Other: Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration, Other: Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration, Other: Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration, Other: Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentrationOnly 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentrationECIG 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	Experiemental
Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentrationECIG 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	Experiemental
Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentrationECIG 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	Experiemental
Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentrationECIG 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.	Other	Experiemental

Primary outcome

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.
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.

2 secondary outcomes

Puff Volume
Time frame: During directed bout, during ad lib bout
Puff Duration
Time frame: During directed bout, during ad lib bout

Results and safety

Results posted to the registry on 4 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
E-cig/Smokers	33	32

Primary outcome: 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.. Mean (Standard Deviation). Unit: mg/ml

Measure	Experimental Arm/ 0mg Condition n = 31	Experimental Arm/ 6mg Condition n = 31	Experimental Arm/ 15 mg Condition n = 31	Experimental Arm/ 30mg Condition n = 31
Before directed bout	2.00 (2.86)	1.92 (2.59)	1.64 (2.34)	1.62 (2.53)
After directed bout	1.93 (2.80)	4.75 (3.44)	8.80 (7.41)	12.42 (12.21)
Before ad lib use	1.74 (2.36)	3.29 (2.29)	5.28 (3.79)	7.62 (5.75)
After ad lib use	1.62 (2.15)	5.39 (3.32)	8.61 (7.47)	11.05 (8.71)
After own brand use	10.93 (9.67)	15.05 (10.04)	16.55 (10.40)	17.01 (9.70)

Population analysed: One arm enrolled and the subjects received each of the 4 conditions. 1 subject with/ missing plasma samples was removed from analysis.

Primary outcome: Cigarette/ECIG Challenge Paradigm

Time frame: Completion of ad lib bout to use of own brand cigarette. Mean (Standard Deviation). Unit: latency to puff own brand in seconds

Measure	Experimental Arm/0 mg Condition n = 32	Experimental Arm/6 mg Condition n = 32	Experimental Arm/ 15 mg Condition n = 32	Experimental Arm/ 30 mg Condition n = 32
Value	7.74 (4.59)	10.18 (12.27)	10.51 (9.57)	11.64 (12.10)

Population analysed: One arm enrolled and the subjects received each of the four conditions per outcome.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data were collected through the subjects participation during the study intervention visits, an average of 2 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Electronic Cigarette Use

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison Breland, PhD study director

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04378907.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.