Electronic Cigarette UseNCT04332926

Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)

A study testing Tobacco product administration and assessment, own brand cigarettes, Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine and Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine 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

This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability. 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?: Tobacco product administration and assessment, own brand cigarettes, Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine and Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 5 Jan 2021to 8 Sep 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, 23220

Other trials in United States

About this study

This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.

Conditions: Electronic Cigarette Use
Being tested: Tobacco product administration and assessment, own brand cigarettes, Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine, Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine, Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine, Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine
Keywords: Electronic Cigarette, Nicotine Flux
Medical subject headings: Vaping

What participants receive

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

Tobacco product administration and assessment, own brand cigarettesOther
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotineOther
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotineOther
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotineOther
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotineOther
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment

Study groups in NCT04332926
Study group	Role	What they receive
Experimental	Experimental	Not described Receives: Other: Tobacco product administration and assessment, own brand cigarettes; Other: Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine; Other: Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine; Other: Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine; Other: Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine

What is being measured

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

Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)
This is now a single-arm parallel study design. The main outcome of interest in the CP-PRT is the relative reinforcing value - defined as how hard a participant is willing to work for the session product compared to their own brand cigarette. The breakpoint, or highest trial number that a participant completed for a puff of the session-specific product will be used as the measure of relative reinforcing value.
Measured: The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.
Breakpoint of Drug Purchase Task (DPT)
The DPTs will yield measures of willingness to pay (demand) for session-specific tobacco products. Choices made during this task are not reinforced during the session. Using the DPT, participants estimate the number of session-specific product puffs they would take across increasing prices per puff. DPT demand will be characterized by the Breakpoint (BP); i.e., the highest price per puff at which participants indicate they would stop using the session-specific product rather than incur the cost.
Measured: Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($).
Effort for Product Puffs With Progressive Ratio Task (PRT)
The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) through the outcome measure: mean number of puffs self-administrated. The outcome measure of interest is the total number of puffs self-administered.
Measured: The PRT is completed once per study session, at 85 minutes into the session.

Timeline

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

5 Jan 20218 Sep 2023

First posted3 Apr 2020
Study start5 Jan 2021
Primary completion1 Jun 2023
Study completion8 Sep 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.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04332926
Sponsor's protocol ID: HM20018290
Other IDs: 2U54DA036105
Status last verified: Jan 2025
First submitted: 25 Mar 2020
Last updated: 13 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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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Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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All Electronic Cigarette Use trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)
ClinicalTrials.gov ID: NCT04332926
Acronym / sponsor ID: HM20018290
Conditions: Electronic Cigarette Use
Keywords: Electronic Cigarette, Nicotine Flux
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 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 Jun 2023 (actual)
Study completion: 8 Sep 2023 (actual)
First posted: 3 Apr 2020 (actual)
Results: Posted 13 Feb 2025

Clinical summary

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

This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Other: Tobacco product administration and assessment, own brand cigarettes, Other: Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine, Other: Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine, Other: Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine, Other: Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine

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
Tobacco product administration and assessment, own brand cigarettes4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment	Other	Experimental
Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment	Other	Experimental
Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment	Other	Experimental
Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment	Other	Experimental
Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment	Other	Experimental

Primary outcome

Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)
Time frame: The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.
This is now a single-arm parallel study design. The main outcome of interest in the CP-PRT is the relative reinforcing value - defined as how hard a participant is willing to work for the session product compared to their own brand cigarette. The breakpoint, or highest trial number that a participant completed for a puff of the session-specific product will be used as the measure of relative reinforcing value.
Breakpoint of Drug Purchase Task (DPT)
Time frame: Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($).
The DPTs will yield measures of willingness to pay (demand) for session-specific tobacco products. Choices made during this task are not reinforced during the session. Using the DPT, participants estimate the number of session-specific product puffs they would take across increasing prices per puff. DPT demand will be characterized by the Breakpoint (BP); i.e., the highest price per puff at which participants indicate they would stop using the session-specific product rather than incur the cost.
Effort for Product Puffs With Progressive Ratio Task (PRT)
Time frame: The PRT is completed once per study session, at 85 minutes into the session.
The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) through the outcome measure: mean number of puffs self-administrated. The outcome measure of interest is the total number of puffs self-administered.

Results and safety

Results posted to the registry on 13 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Enrollment	44	32

Primary outcome: Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)

Time frame: The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.. Mean (Standard Deviation). Unit: Breakpoint (highest trial completed)

Measure	Experimental n = 32
ECIG 30 Watts, 0 mg/ml nicotine	6.30 (2.83)
ECIG 30 Watts, 8 mg/ml nicotine	6.38 (2.94)
ECIG 30 Watts, 15 mg/ml nicotine	6.34 (2.70)
ECIG 30 Watts, 30 mg/ml nicotine	5.94 (2.93)

Population analysed: The study morphed from a cross-over study into a single-arm study due to feasibility issues. Instead of different arms completing the interventions in a different order, all of the subjects were moved into one arm and completed the interventions in the same order.

Primary outcome: Breakpoint of Drug Purchase Task (DPT)

Time frame: Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($).. Mean (Standard Deviation). Unit: US dollars ($)

Measure	Experimental n = 32
Own Brand Cigarette	1.23 (2.10)
ECIG 30 Watts, 0 mg/ml nicotine	0.54 (0.90)
ECIG 30 Watts, 8 mg/ml nicotine	0.96 (1.78)
ECIG 30 Watts, 15 mg/ml nicotine	0.43 (0.77)
ECIG 30 Watts, 30 mg/ml nicotine	0.49 (1.01)

Primary outcome: Effort for Product Puffs With Progressive Ratio Task (PRT)

Time frame: The PRT is completed once per study session, at 85 minutes into the session.. Mean (Standard Deviation). Unit: Number of puffs

Measure	Experimental n = 32
Own Brand Cigarette	9.06 (2.73)
ECIG 30 Watts, 0 mg/ml nicotine	7.69 (3.51)
ECIG 30 Watts, 8 mg/ml nicotine	7.88 (3.42)
ECIG 30 Watts, 15 mg/ml nicotine	7.31 (3.89)
ECIG 30 Watts, 30 mg/ml nicotine	6.34 (4.37)

Adverse events

Time frame: Data were collected during laboratory visits, approximately over 3 weeks; no follow up adverse event data collection occurred.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	1 of 44 (2.3%)	3 of 44 (6.8%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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.

Caroline O Cobb, PhD principal investigator

Virginia Commonwealth University

Andrew Barnes, PhD principal investigator

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 13 Feb 2025. 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 13 Feb 2025). 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?

Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT) (time frame: The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.). The study lists 3 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 NCT04332926.

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 13 Feb 2025.