Electronic CigarettesNCT03710590

Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

A study testing ECIG Lab Session 15 watts, 10 mg nicotine, ECIG Lab Session 15 watts, 15 mg nicotine and ECIG Lab Session 15 watts, 30 mg nicotine in people with Electronic Cigarettes, 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

Search all trials

Trial summary

The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Electronic Cigarettes
What is being tested?: ECIG Lab Session 15 watts, 10 mg nicotine, ECIG Lab Session 15 watts, 15 mg nicotine and ECIG Lab Session 15 watts, 30 mg nicotine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2019to 9 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 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.
Individuals who weigh less than 110 pounds
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

Clinical Behavioral Pharmacolgy Laboratory
Richmond, Virginia, 23298

Other trials in United States

About this study

Conditions: Electronic Cigarettes
Being tested: ECIG Lab Session 15 watts, 10 mg nicotine, ECIG Lab Session 15 watts, 15 mg nicotine, ECIG Lab Session 15 watts, 30 mg nicotine, ECIG Lab Session 30 watts, 10 mg nicotine, ECIG Lab Session 30 watts, 15 mg nicotine
Medical subject headings: Vaping

What participants receive

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

ECIG Lab Session 15 watts, 10 mg nicotineOther
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
ECIG Lab Session 15 watts, 15 mg nicotineOther
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).
ECIG Lab Session 15 watts, 30 mg nicotineOther
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
ECIG Lab Session 30 watts, 10 mg nicotineOther
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
ECIG Lab Session 30 watts, 15 mg nicotineOther
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
ECIG Lab Session 30 watts, 30 mg nicotineOther
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 NCT03710590
Study group	Role	What they receive
Cigarette smokers	Active comparator	Not described Receives: Other: ECIG Lab Session 15 watts, 10 mg nicotine; Other: ECIG Lab Session 15 watts, 15 mg nicotine; Other: ECIG Lab Session 15 watts, 30 mg nicotine; Other: ECIG Lab Session 30 watts, 10 mg nicotine; Other: ECIG Lab Session 30 watts, 15 mg nicotine; Other: ECIG Lab Session 30 watts, 30 mg nicotine
Electronic cigarette users	Active comparator	Not described Receives: Other: ECIG Lab Session 15 watts, 10 mg nicotine; Other: ECIG Lab Session 15 watts, 15 mg nicotine; Other: ECIG Lab Session 15 watts, 30 mg nicotine; Other: ECIG Lab Session 30 watts, 10 mg nicotine; Other: ECIG Lab Session 30 watts, 15 mg nicotine; Other: ECIG Lab Session 30 watts, 30 mg nicotine

What is being measured

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

Change in Plasma Nicotine
Change in plasma nicotine level.
Measured: Baseline to 5 min after the start of a 10-puff product use
Puff Volume
The average volume of each puff, in ml, during 10 puff bout.
Measured: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
Puff Duration
The average duration of each puff, in seconds.
Measured: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes

Secondary outcomes (1)

Heart Rate
Average heart rate, measured in beats per minute.
Measured: Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes

Timeline

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

15 Jan 20199 Mar 2020

First posted18 Oct 2018
Study start15 Jan 2019
Primary completion9 Mar 2020
Study completion9 Mar 2020

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 (1)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: Non-randomised
Intervention model: Crossover
Model description: The purpose of this study is to determine differences in nicotine delivery, use behavior (puff topography), carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers and experienced electronic cigarette users use an electronic cigarette with different settings (different voltage and resistance settings, which together determine power levels) and different e-liquid concentrations.
Masking: Single blind
Who is masked: Participant
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03710590
Sponsor's protocol ID: HM20012738
Other IDs: U54DA036105
Status last verified: Sep 2022
First submitted: 9 Oct 2018
Last updated: 6 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Eversole A, Budd S, Karaoghlanian N, Lipato T, Eissenberg T, Breland AB. Interactive effects of protonated nicotine concentration and device power on ENDS nicotine delivery, puff topography, and subjective effects. Exp Clin Psychopharmacol. 2023 Apr;31(2):443-454. doi: 10.1037/pha0000576. Epub 2022 Jun 13.
PubMed 35696157

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

Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems

All Electronic Cigarettes trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users
ClinicalTrials.gov ID: NCT03710590
Acronym / sponsor ID: HM20012738
Conditions: Electronic Cigarettes
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 15 Jan 2019 (actual)
Primary completion: 9 Mar 2020 (actual)
Study completion: 9 Mar 2020 (actual)
First posted: 18 Oct 2018 (actual)
Results: Posted 20 May 2021

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: The purpose of this study is to determine differences in nicotine delivery, use behavior (puff topography), carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers and experienced electronic cigarette users use an electronic cigarette with different settings (different voltage and resistance settings, which together determine power levels) and different e-liquid concentrations.

Arm	Type	Receives
Cigarette smokers	Active comparator	Other: ECIG Lab Session 15 watts, 10 mg nicotine, Other: ECIG Lab Session 15 watts, 15 mg nicotine, Other: ECIG Lab Session 15 watts, 30 mg nicotine, Other: ECIG Lab Session 30 watts, 10 mg nicotine, Other: ECIG Lab Session 30 watts, 15 mg nicotine, Other: ECIG Lab Session 30 watts, 30 mg nicotine
Electronic cigarette users	Active comparator	Other: ECIG Lab Session 15 watts, 10 mg nicotine, Other: ECIG Lab Session 15 watts, 15 mg nicotine, Other: ECIG Lab Session 15 watts, 30 mg nicotine, Other: ECIG Lab Session 30 watts, 10 mg nicotine, Other: ECIG Lab Session 30 watts, 15 mg nicotine, Other: ECIG Lab Session 30 watts, 30 mg 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 (3 listed)

Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
Individuals who weigh less than 110 pounds
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
ECIG Lab Session 15 watts, 10 mg nicotineDuring 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, Electronic cigarette users
ECIG Lab Session 15 watts, 15 mg nicotineDuring 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, Electronic cigarette users
ECIG Lab Session 15 watts, 30 mg nicotineDuring 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, Electronic cigarette users
ECIG Lab Session 30 watts, 10 mg nicotineDuring 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, Electronic cigarette users
ECIG Lab Session 30 watts, 15 mg nicotineDuring 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, Electronic cigarette users
ECIG Lab Session 30 watts, 30 mg nicotineDuring 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, Electronic cigarette users

Primary outcome

Change in Plasma Nicotine
Time frame: Baseline to 5 min after the start of a 10-puff product use
Change in plasma nicotine level.
Puff Volume
Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
The average volume of each puff, in ml, during 10 puff bout.
Puff Duration
Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
The average duration of each puff, in seconds.

1 secondary outcome

Heart Rate
Time frame: Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes

Results and safety

Results posted to the registry on 20 May 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
Cigarette Smokers	22	12
E-cigarette Users	23	15

Primary outcome: Change in Plasma Nicotine

Time frame: Baseline to 5 min after the start of a 10-puff product use. Mean (Standard Deviation). Unit: ng/ml

Measure	Cigarette Smokers n = 12	E-cigarette Users n = 15
10mg 15 Watts	8.68 (7.22)	8.28 (9.65)
10mg 30 Watts	9.53 (7.53)	12.00 (10.29)
15mg 15 Watts	7.34 (6.19)	7.17 (6.14)
15mg 30 Watts	13.04 (13.14)	14.04 (12.08)
30mg 15 Watts	10.18 (9.28)	20.12 (22.40)
30mg 30 Watts	17.28 (18.05)	22.38 (21.04)

Primary outcome: Puff Volume

Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes. Mean (Standard Deviation). Unit: ml

Measure	Cigarette Smokers n = 11	E-cigarette Users n = 15
10 mg, 15 Watts	457.27 (223.02)	748.34 (412.22)
10 mg, 30 Watts	245.11 (124.09)	503.43 (216.28)
15 mg, 15 Watts	350.18 (190.97)	708.62 (300.45)
15 mg, 30 Watts	217.01 (94.99)	409.56 (208.61)
30 mg, 15 Watts	310.95 (199.06)	631.23 (225.84)
30 mg, 30 Watts	176.32 (79.76)	415.85 (186.33)

Population analysed: One participant did not have data for this measure.

Primary outcome: Puff Duration

Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes. Mean (Standard Deviation). Unit: seconds

Measure	Cigarette Smokers n = 11	E-cigarette Users n = 15
10 mg, 15 W	3.04 (1.01)	4.37 (1.15)
10 mg, 30 W	1.97 (0.65)	2.83 (0.71)
15 mg, 15 W	2.59 (0.53)	4.02 (1.27)
15 mg, 30 W	1.65 (0.43)	2.72 (1.05)
30 mg, 15 W	2.44 (0.83)	3.41 (1.01)
30 mg, 30 W	1.58 (0.45)	2.45 (0.84)

Population analysed: One participant did not have data collected for this measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During each of 6 approximately 4-hour session over up to a 3 week period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cigarette Smokers	0 of 12 (0%)	0 of 12 (0%)	0 of 12
E-cigarette Users	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35696157Eversole A, Budd S, Karaoghlanian N, Lipato T, Eissenberg T, Breland AB. Interactive effects of protonated nicotine concentration and device power on ENDS nicotine delivery, puff topography, and subjective effects. Exp Clin Psychopharmacol. 2023 Apr;31(2):443-454. doi: 10.1037/pha0000576. Epub 2022 Jun 13.
Individual participant dataSharing planned: No

Related trials for Electronic Cigarettes

Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems

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 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 3 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 6 Oct 2022. 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 20 May 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?

Change in Plasma Nicotine (time frame: Baseline to 5 min after the start of a 10-puff product use). 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 NCT03710590, which also lists 1 linked publication.

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 6 Oct 2022.