Electronic CigarettesNCT03830892

Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

A study testing E-cigarette Lab Session 15 watts, 10 mg nicotine, E-cigarette Lab Session 15 watts, 30 mg nicotine and E-cigarette Lab Session 30 watts, 10 mg nicotine in people with Electronic Cigarettes, run by Virginia Commonwealth University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes. Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Electronic Cigarettes
What is being tested?: E-cigarette Lab Session 15 watts, 10 mg nicotine, E-cigarette Lab Session 15 watts, 30 mg nicotine and E-cigarette Lab Session 30 watts, 10 mg nicotine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 18 Jan 2019to 6 Mar 2020
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 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healthy (determined by self-report)
between the ages of 21-55
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 understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.

Conditions: Electronic Cigarettes
Being tested: E-cigarette Lab Session 15 watts, 10 mg nicotine, E-cigarette Lab Session 15 watts, 30 mg nicotine, E-cigarette Lab Session 30 watts, 10 mg nicotine, E-cigarette Lab Session 30 watts, 30 mg nicotine, Own Brand Session - E-cigarette
Medical subject headings: Vaping

What participants receive

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

E-cigarette Lab Session 15 watts, 10 mg nicotineOther
E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotineOther
E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotineOther
E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotineOther
E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigaretteOther
E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/CigaretteOther
Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power

Study groups in NCT03830892
Study group	Role	What they receive
E-cigarette User (Exclusive)	Active comparator	Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette Receives: Other: E-cigarette Lab Session 15 watts, 10 mg nicotine; Other: E-cigarette Lab Session 15 watts, 30 mg nicotine; Other: E-cigarette Lab Session 30 watts, 10 mg nicotine; Other: E-cigarette Lab Session 30 watts, 30 mg nicotine; Other: Own Brand Session - E-cigarette
Dual User	Active comparator	Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette Receives: Other: E-cigarette Lab Session 15 watts, 10 mg nicotine; Other: E-cigarette Lab Session 15 watts, 30 mg nicotine; Other: E-cigarette Lab Session 30 watts, 10 mg nicotine; Other: E-cigarette Lab Session 30 watts, 30 mg nicotine; Other: Own Brand Session - E-cigarette; Other: Own Brand Session - E-cigarette/Cigarette

What is being measured

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

Breakpoint of Drug Purchase Tasks (DPT)
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Measured: Up to 180 minutes
Breakpoint of Multiple Choice Procedure (MCP)
The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Measured: Up to 180 minutes.
Effort for Product Puffs With the 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) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Measured: Up to 180 minutes.

Timeline

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

18 Jan 20196 Mar 2020

First posted5 Feb 2019
Study start18 Jan 2019
Primary completion6 Mar 2020
Study completion6 Mar 2020

Why it stopped: Study terminated due to COVID

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Electronic CigarettesStudies 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: Randomised
Intervention model: Crossover
Model description: We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes. All participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette. The first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.
Masking: Single blind
Who is masked: Participant
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03830892
Sponsor's protocol ID: HM20012696
Other IDs: 2U54DA036105
Status last verified: May 2021
First submitted: 14 Jan 2019
Last updated: 4 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Bono RS, White AM, Hoetger C, Lipato T, Bickel WK, Cobb CO, Barnes AJ. Expanding on cross-price elasticity: Understanding tobacco product demand and substitution from the cross-price purchase task. J Exp Anal Behav. 2024 Mar;121(2):175-188. doi: 10.1002/jeab.890. Epub 2023 Nov 21.
PubMed 37988256
White AM, Bono RS, Lester RC, Underwood M, Hoetger C, Lipato T, Bickel WK, Cobb CO, Barnes AJ. The electronic nicotine delivery system (ENDS) purchase task: Are results sensitive to price framing? Exp Clin Psychopharmacol. 2023 Oct;31(5):895-901. doi: 10.1037/pha0000631. Epub 2022 Dec 8.
PubMed 36480388
Hoetger C, Bono RS, White AM, Barnes AJ, Cobb CO. The interaction of nicotine concentration and device power on electronic nicotine delivery system (ENDS) abuse liability among exclusive ENDS users and dual users of ENDS and combustible cigarettes. Exp Clin Psychopharmacol. 2022 Dec;30(6):973-982. doi: 10.1037/pha0000523. Epub 2021 Oct 14.
PubMed 34647773

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 Cigarettes trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers
ClinicalTrials.gov ID: NCT03830892
Acronym / sponsor ID: HM20012696
Conditions: Electronic Cigarettes
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated due to COVID
Enrolment: 48 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 18 Jan 2019 (actual)
Primary completion: 6 Mar 2020 (actual)
Study completion: 6 Mar 2020 (actual)
First posted: 5 Feb 2019 (actual)
Results: Posted 4 Jun 2021

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 understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes. All participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette. The first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.

Arm	Type	Receives
E-cigarette User (Exclusive)	Active comparator	Other: E-cigarette Lab Session 15 watts, 10 mg nicotine, Other: E-cigarette Lab Session 15 watts, 30 mg nicotine, Other: E-cigarette Lab Session 30 watts, 10 mg nicotine, Other: E-cigarette Lab Session 30 watts, 30 mg nicotine, Other: Own Brand Session - E-cigaretteOther: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
Dual User	Active comparator	Other: E-cigarette Lab Session 15 watts, 10 mg nicotine, Other: E-cigarette Lab Session 15 watts, 30 mg nicotine, Other: E-cigarette Lab Session 30 watts, 10 mg nicotine, Other: E-cigarette Lab Session 30 watts, 30 mg nicotine, Other: Own Brand Session - E-cigarette, Other: Own Brand Session - E-cigarette/CigaretteOther: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette

Who may qualify

Ages: 21 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 21-55
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
E-cigarette Lab Session 15 watts, 10 mg nicotineE-cigarette paired with low nicotine, low device power	Other	Dual User, E-cigarette User (Exclusive)
E-cigarette Lab Session 15 watts, 30 mg nicotineE-cigarette paired with low nicotine, low device power	Other	Dual User, E-cigarette User (Exclusive)
E-cigarette Lab Session 30 watts, 10 mg nicotineE-cigarette paired with low nicotine, low device power	Other	Dual User, E-cigarette User (Exclusive)
E-cigarette Lab Session 30 watts, 30 mg nicotineE-cigarette paired with low nicotine, low device power	Other	Dual User, E-cigarette User (Exclusive)
Own Brand Session - E-cigaretteE-cigarette paired with own brand liquid and preferred power	Other	Dual User, E-cigarette User (Exclusive)
Own Brand Session - E-cigarette/CigaretteOwn brand cigarette OR E-cigarette paired with own brand liquid and preferred power	Other	Dual User

Primary outcome

Breakpoint of Drug Purchase Tasks (DPT)
Time frame: Up to 180 minutes
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Breakpoint of Multiple Choice Procedure (MCP)
Time frame: Up to 180 minutes.
The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Effort for Product Puffs With the Progressive Ratio Task (PRT)
Time frame: Up to 180 minutes.
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) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).

Results and safety

Results posted to the registry on 4 Jun 2021, 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-cigarette User (Exclusive)	25	19
Dual User	23	17

Primary outcome: Breakpoint of Drug Purchase Tasks (DPT)

Time frame: Up to 180 minutes. Mean (Standard Deviation). Unit: US Dollars

Measure	E-cigarette User (Exclusive) n = 19	Dual User n = 13
own brand e-cigarette	3.95 (3.59)	3.79 (3.09)
30 watts, 30 mg/ml nicotine	3.29 (3.73)	4.43 (3.74)
15 watts, 30 mg/ml nicotine	3.51 (3.41)	4.26 (3.63)
30 watts, 10 mg/ml nicotine	3.37 (3.43)	4.23 (3.77)
15 watts, 10 mg/ml nicotine	3.74 (3.50)	4.80 (3.86)

Population analysed: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.

Primary outcome: Breakpoint of Multiple Choice Procedure (MCP)

Time frame: Up to 180 minutes.. Mean (Standard Deviation). Unit: US Dollars

Measure	E-cigarette User (Exclusive) n = 19	Dual User n = 13
Own brand e-cigarette	3.05 (2.92)	2.90 (2.99)
30 watts, 30 mg/ml nicotine	2.51 (3.18)	2.36 (2.41)
15 watts, 30 mg/ml nicotine	2.56 (2.93)	2.51 (1.98)
30 watts, 10 mg/ml nicotine	2.63 (2.98)	2.10 (2.06)
15 watts, 10 mg/ml nicotine	2.35 (2.13)	2.23 (2.34)

Population analysed: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.

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

Time frame: Up to 180 minutes.. Mean (Standard Deviation). Unit: e-cigarette puffs

Measure	E-cigarette User (Exclusive) n = 19	Dual User n = 13
own brand e-cigarette	4.95 (1.54)	4.54 (1.56)
30 watts, 30 mg/ml nicotine	4.74 (1.88)	4.54 (1.76)
15 watts, 30 mg/ml nicotine	4.58 (1.77)	4.38 (2.06)
30 watts, 10 mg/ml nicotine	5.58 (1.68)	5.38 (1.56)
15 watts, 10 mg/ml nicotine	4.89 (1.59)	4.77 (1.92)

Population analysed: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
E-cigarette User (Exclusive)	1 of 19 (5.3%)	3 of 19 (15.8%)	0 of 19
Dual User	0 of 13 (0%)	7 of 13 (53.8%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37988256Bono RS, White AM, Hoetger C, Lipato T, Bickel WK, Cobb CO, Barnes AJ. Expanding on cross-price elasticity: Understanding tobacco product demand and substitution from the cross-price purchase task. J Exp Anal Behav. 2024 Mar;121(2):175-188. doi: 10.1002/jeab.890. Epub 2023 Nov 21.
Derived from this study: PubMed 36480388White AM, Bono RS, Lester RC, Underwood M, Hoetger C, Lipato T, Bickel WK, Cobb CO, Barnes AJ. The electronic nicotine delivery system (ENDS) purchase task: Are results sensitive to price framing? Exp Clin Psychopharmacol. 2023 Oct;31(5):895-901. doi: 10.1037/pha0000631. Epub 2022 Dec 8.
Derived from this study: PubMed 34647773Hoetger C, Bono RS, White AM, Barnes AJ, Cobb CO. The interaction of nicotine concentration and device power on electronic nicotine delivery system (ENDS) abuse liability among exclusive ENDS users and dual users of ENDS and combustible cigarettes. Exp Clin Psychopharmacol. 2022 Dec;30(6):973-982. doi: 10.1037/pha0000523. Epub 2021 Oct 14.
Individual participant dataSharing planned: Undecided

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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 Cobb (Amey), 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: stopped early, as of the sponsor's last update on 4 Jun 2021. 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 Jun 2021). 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?

Breakpoint of Drug Purchase Tasks (DPT) (time frame: Up to 180 minutes). 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 NCT03830892, which also lists 3 linked publications.

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 Jun 2021.