Electronic CigarettesNCT03861078

The Effect of Electronic Cigarette Liquid Characteristics in Smokers.

A study testing Own Brand Cigarette, ECIG 15 mg nicotine, sweetened and ECIG 15 mg nicotine, unsweet 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

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Trial summary

The purpose of this study is to determine differences in nicotine delivery, user behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of 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?: Own Brand Cigarette, ECIG 15 mg nicotine, sweetened and ECIG 15 mg nicotine, unsweet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 17 Feb 2020to 13 Dec 2021
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 years old
Current cigarette smokers
Wiling to provide informed consent
Able to attend the lab session and abstain from tobacco/nicotine products as required
Agree to use designated products according to the 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 Pharmacology Laboratory
Richmond, Virginia, 23298

Other trials in United States

About this study

Conditions: Electronic Cigarettes
Being tested: Own Brand Cigarette, ECIG 15 mg nicotine, sweetened, ECIG 15 mg nicotine, unsweet, ECIG 0 mg nicotine, sweetened, ECIG 0 mg nicotine, unsweet
Medical subject headings: Vaping

What participants receive

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

Own Brand CigaretteOther
Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetenedOther
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweetOther
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetenedOther
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweetOther
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid

Study groups in NCT03861078
Study group	Role	What they receive
Cigarette smokers	Experimental	Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task. Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened Receives: Other: Own Brand Cigarette; Other: ECIG 15 mg nicotine, sweetened; Other: ECIG 15 mg nicotine, unsweet; Other: ECIG 0 mg nicotine, sweetened; Other: ECIG 0 mg nicotine, unsweet

What is being measured

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

Plasma Nicotine Concentration
Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout.
Measured: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).
Progressive Ratio Task - Breakpoint
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here.
Measured: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Progressive Ratio Task - Number of Puffs
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here.
Measured: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Progressive Ratio Task - Latency
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here.
Measured: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.

Secondary outcomes (2)

Puff Volume
The volume of each puff, in ml, averaged over the 10-puff use bout
Measured: Puff volume will be measured during the approximately 5-minute, 10-puff use bout.
Puff Duration
The duration of each puff, in seconds, averaged over the 10-puff use bout
Measured: The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.

Timeline

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

17 Feb 202013 Dec 2021

First posted4 Mar 2019
Study start17 Feb 2020
Primary completion13 Dec 2021
Study completion13 Dec 2021

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: Not applicable
Intervention model: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03861078
Sponsor's protocol ID: HM20015258
Other IDs: U54DA036105, F31DA047018
Status last verified: Nov 2022
First submitted: 14 Jan 2019
Last updated: 23 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Maloney SF, Hoetger C, Bono RS, Lester Scholtes R, Combs M, Karaoghlanian N, Lipato T, Breland A, Eissenberg T. Assessment of human abuse potential of an unflavored, sucralose-sweetened electronic cigarette in combustible cigarette smokers. Exp Clin Psychopharmacol. 2024 Oct;32(5):588-603. doi: 10.1037/pha0000720. Epub 2024 May 30.
PubMed 38815111

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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Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
ClinicalTrials.gov ID: NCT03861078
Acronym / sponsor ID: HM20015258
Conditions: Electronic Cigarettes
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 17 Feb 2020 (actual)
Primary completion: 13 Dec 2021 (actual)
Study completion: 13 Dec 2021 (actual)
First posted: 4 Mar 2019 (actual)
Results: Posted 23 Dec 2022

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: Not applicable
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cigarette smokers	Experimental	Other: Own Brand Cigarette, Other: ECIG 15 mg nicotine, sweetened, Other: ECIG 15 mg nicotine, unsweet, Other: ECIG 0 mg nicotine, sweetened, Other: ECIG 0 mg nicotine, unsweetEach participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task. Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy (determined by self-report)
Between the ages of 21-55 years old
Current cigarette smokers
Wiling to provide informed consent
Able to attend the lab session and abstain from tobacco/nicotine products as required

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
Own Brand CigaretteEffects of own brand cigarette use.	Other	Cigarette smokers
ECIG 15 mg nicotine, sweetenedEffects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid	Other	Cigarette smokers
ECIG 15 mg nicotine, unsweetEffects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid	Other	Cigarette smokers
ECIG 0 mg nicotine, sweetenedEffects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid	Other	Cigarette smokers
ECIG 0 mg nicotine, unsweetEffects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid	Other	Cigarette smokers

Primary outcome

Plasma Nicotine Concentration
Time frame: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).
Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout.
Progressive Ratio Task - Breakpoint
Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here.
Progressive Ratio Task - Number of Puffs
Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here.
Progressive Ratio Task - Latency
Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here.

2 secondary outcomes

Puff Volume
Time frame: Puff volume will be measured during the approximately 5-minute, 10-puff use bout.
Puff Duration
Time frame: The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.

Results and safety

Results posted to the registry on 23 Dec 2022, 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	14

Primary outcome: Plasma Nicotine Concentration

Time frame: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).. Mean (Standard Deviation). Unit: ng/ml

Measure	Cigarette Smokers n = 13
Own Brand	12.32 (8.3)
Unsweetened, 0 mg/ml nicotine	-0.22 (1.0)
Unsweetened, 15 mg/ml nicotine	7.09 (8.6)
Sweetened, 15 mg/ml nicotine	5.85 (7.0)
Sweetened, 0 mg/ml nicotine	-0.29 (1.1)

Population analysed: One participant had incomplete blood data and was excluded from the analysis.

Primary outcome: Progressive Ratio Task - Breakpoint

Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.. Mean (Standard Deviation). Unit: Key presses

Measure	Cigarette Smokers n = 14
Unsweetened, 0 mg/ml nicotine	416.07 (502.0)
Sweetened, 0 mg/ml nicotine	307.29 (415.3)
Unsweetened, 15 mg/ml nicotine	336.43 (687.3)
Sweetened, 15 mg/ml nicotine	492.86 (811.0)
Own brand cigarette	812.86 (1132.3)

Population analysed: Cigarette smokers

Primary outcome: Progressive Ratio Task - Number of Puffs

Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.. Mean (Standard Deviation). Unit: Number of puffs

Measure	Cigarette Smokers n = 14
Unsweetened, 0 mg/ml nicotine	7.64 (4.2)
Sweetened, 0 mg/ml nicotine	6.21 (4.7)
Unsweetened, 15 mg/ml nicotine	5.07 (5.1)
Sweetened, 15 mg/ml nicotine	7.21 (5.0)
Own brand cigarette	9.93 (4.1)

Population analysed: Cigarette smokers

Primary outcome: Progressive Ratio Task - Latency

Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.. Mean (Standard Deviation). Unit: milliseconds

Measure	Cigarette Smokers n = 14
Unsweetened, 0 mg/ml nicotine	161176.93 (473649.1)
Sweetened, 0 mg/ml nicotine	390300.43 (764004.4)
Unsweetened, 15 mg/ml nicotine	315803.79 (636134.5)
Sweetened, 15 mg/ml nicotine	263130.86 (651141.0)
Own brand cigarette	6500.64 (6972.8)

Population analysed: Cigarette smokers

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Cigarette Smokers	0 of 0	0 of 0
ECIG 15 mg Nicotine, Sweetened	0 of 0	0 of 0
ECIG 15 mg Nicotine, Unsweet	0 of 0	0 of 0
ECIG 0 mg Nicotine, Sweetened	0 of 0	0 of 0
ECIG 0 mg Nicotine, Unsweet	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38815111Maloney SF, Hoetger C, Bono RS, Lester Scholtes R, Combs M, Karaoghlanian N, Lipato T, Breland A, Eissenberg T. Assessment of human abuse potential of an unflavored, sucralose-sweetened electronic cigarette in combustible cigarette smokers. Exp Clin Psychopharmacol. 2024 Oct;32(5):588-603. doi: 10.1037/pha0000720. Epub 2024 May 30.
Individual participant dataSharing planned: No

Related trials for Electronic Cigarettes

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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 6 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 23 Dec 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 23 Dec 2022). 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: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).). The study lists 4 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 NCT03861078, 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 23 Dec 2022.