ClinicalTrials.gg
Sign In
CompletedNCT03710590Updated Oct 6, 2022Results posted

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

An interventional study of ECIG Lab Session 15 watts, 10 mg nicotine and ECIG Lab Session 15 watts, 15 mg nicotine in Electronic Cigarettes, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-06.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Electronic Cigarettes

Browse trials for

03

In context

Vaping

172 studies on the registry are indexed under Vaping; 75 are open to participants now.

This study's enrollment of 45 is below the median of 105 across 144 interventional studies indexed under Vaping.

Browse Vaping studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 82 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.

Browse Virginia Commonwealth University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Cigarette smokers

    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

  • Active comparator
    Electronic cigarette users

    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

Interventions

  • OtherECIG Lab Session 15 watts, 10 mg nicotine

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

  • OtherECIG Lab Session 15 watts, 15 mg nicotine

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).

  • OtherECIG Lab Session 15 watts, 30 mg nicotine

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

  • OtherECIG Lab Session 30 watts, 10 mg nicotine

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

  • OtherECIG Lab Session 30 watts, 15 mg nicotine

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

  • OtherECIG Lab Session 30 watts, 30 mg nicotine

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

06

What researchers measure

Primary outcomes

  1. Change in Plasma Nicotine

    Change in plasma nicotine level.

    Time frame: Baseline to 5 min after the start of a 10-puff product use

  2. Puff Volume

    The average volume of each puff, in ml, during 10 puff bout.

    Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes

  3. Puff Duration

    The average duration of each puff, in seconds.

    Time frame: 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.

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

Other outcomes

  1. Inter Puff Interval

    The time between each puff, in seconds

    Time frame: Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period

  2. Flow Rate

    The rate of air flow during each puff, in ml/second

    Time frame: Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period

  3. Hughes-Hatsukami Questionnaire

    This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.

    Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.

  4. Direct Effects of Product Use Questionnaire

    This scale is used to assess how product use makes participants feel and consists of 10 questions that are scored 0 - 100. There are no sub-scales. Items are analyzed separately.

    Time frame: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approximately 1-hour ad lib use period.

  5. Direct Effects of Nicotine Questionnaire

    This scale is used to assess how product use makes participants feel, and consists of 10 questions that are scored 0 - 100.There are no sub-scales. Items are analyzed separately.

    Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.

  6. Carbon Monoxide Levels

    Change in carbon monoxide levels (in parts per mission)

    Time frame: Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.

  7. Blood Pressure

    Change in blood pressure, measured in mm/hg

    Time frame: Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session

  8. General Labeled Magnitude Scale

    This scale measures the flavor sensation, harshness, and throat hit (in three questions that correspond to those constructs) of the e-cigarette used in each session. The scale ranges from 0 - 100, with 0 being no sensation and 100 being the strongest imaginable sensation of any kind. Each item if scored nd analyzed separately (there are no sub-scales).

    Time frame: The General Labeled Magnitude Scale will be administered twice in each approximately 4 hour session--after a 5-minute 10 puff use bout, and after the approximately 90 minute ad lib period.

07

Results

Posted May 20, 2021

Participant flow

Not-completed reason was not stored by treatment arm

Participant flow — Overall Study
MilestoneCigarette SmokersE-cigarette Users
Started2223
Session 1: ecig lab session 15 watts, 10 mg nicotine1215
Session 2: ecig lab session 15 watts, 15 mg nicotine1215
Session 3: ecig lab session 15 watts, 30 mg nicotine1215
Session 4: ecig lab session 30 watts, 10 mg nicotine1215
Session 5: ecig lab session 30 watts, 15 mg nicotine1215
Session 6: ecig lab session 30 watts, 30 mg nicotine1215
Completed1215
Not completed108
Withdrew: Lost to follow up, study stopped due to covid-19, other reasons108

Outcome measures

PrimaryChange in Plasma Nicotine

Change in plasma nicotine level.

Time frame:
Baseline to 5 min after the start of a 10-puff product use
Reported as:
Mean · ng/ml
Change in Plasma Nicotine
ng/mlCigarette SmokersE-cigarette Users
10mg 15 Watts8.68 ± 7.228.28 ± 9.65
10mg 30 Watts9.53 ± 7.5312.00 ± 10.29
15mg 15 Watts7.34 ± 6.197.17 ± 6.14
15mg 30 Watts13.04 ± 13.1414.04 ± 12.08
30mg 15 Watts10.18 ± 9.2820.12 ± 22.40
30mg 30 Watts17.28 ± 18.0522.38 ± 21.04
PrimaryPuff Volume

The average volume of each puff, in ml, during 10 puff bout.

Time frame:
Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
Reported as:
Mean · ml
Puff Volume
mlCigarette SmokersE-cigarette Users
10 mg, 15 Watts457.27 ± 223.02748.34 ± 412.22
10 mg, 30 Watts245.11 ± 124.09503.43 ± 216.28
15 mg, 15 Watts350.18 ± 190.97708.62 ± 300.45
15 mg, 30 Watts217.01 ± 94.99409.56 ± 208.61
30 mg, 15 Watts310.95 ± 199.06631.23 ± 225.84
30 mg, 30 Watts176.32 ± 79.76415.85 ± 186.33
PrimaryPuff Duration

The average duration of each puff, in seconds.

Time frame:
Each time the e-cigarette is used during the 10-puff use bout - 5 minutes
Reported as:
Mean · seconds
Puff Duration
secondsCigarette SmokersE-cigarette Users
10 mg, 15 W3.04 ± 1.014.37 ± 1.15
10 mg, 30 W1.97 ± 0.652.83 ± 0.71
15 mg, 15 W2.59 ± 0.534.02 ± 1.27
15 mg, 30 W1.65 ± 0.432.72 ± 1.05
30 mg, 15 W2.44 ± 0.833.41 ± 1.01
30 mg, 30 W1.58 ± 0.452.45 ± 0.84
SecondaryHeart Rate

Average heart rate, measured in beats per minute.

Time frame:
Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes
Reported as:
Mean · bpm
Heart Rate
bpmCigarette SmokersE-cigarette Users
10 mg, 15 Watts75.66 ± 6.8875.01 ± 10.44
10 mg, 30 Watts78.19 ± 7.2579.92 ± 15.30
15 mg, 15 Watts72.64 ± 6.3279.09 ± 15.30
15 mg, 30 Watts76.05 ± 6.9180.27 ± 12.51
30 mg, 15 Watts77.12 ± 8.8378.56 ± 12.67
30 mg, 30 Watts80.12 ± 8.9584.51 ± 14.79
Other pre-specifiedInter Puff Interval

The time between each puff, in seconds

Time frame:
Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period

Results for this outcome have not been posted.

Other pre-specifiedFlow Rate

The rate of air flow during each puff, in ml/second

Time frame:
Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period

Results for this outcome have not been posted.

Other pre-specifiedHughes-Hatsukami Questionnaire

This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.

Time frame:
Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.

Results for this outcome have not been posted.

Other pre-specifiedDirect Effects of Product Use Questionnaire

This scale is used to assess how product use makes participants feel and consists of 10 questions that are scored 0 - 100. There are no sub-scales. Items are analyzed separately.

Time frame:
Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approximately 1-hour ad lib use period.

Results for this outcome have not been posted.

Other pre-specifiedDirect Effects of Nicotine Questionnaire

This scale is used to assess how product use makes participants feel, and consists of 10 questions that are scored 0 - 100.There are no sub-scales. Items are analyzed separately.

Time frame:
Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.

Results for this outcome have not been posted.

Other pre-specifiedCarbon Monoxide Levels

Change in carbon monoxide levels (in parts per mission)

Time frame:
Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.

Results for this outcome have not been posted.

Other pre-specifiedBlood Pressure

Change in blood pressure, measured in mm/hg

Time frame:
Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session

Results for this outcome have not been posted.

Other pre-specifiedGeneral Labeled Magnitude Scale

This scale measures the flavor sensation, harshness, and throat hit (in three questions that correspond to those constructs) of the e-cigarette used in each session. The scale ranges from 0 - 100, with 0 being no sensation and 100 being the strongest imaginable sensation of any kind. Each item if scored nd analyzed separately (there are no sub-scales).

Time frame:
The General Labeled Magnitude Scale will be administered twice in each approximately 4 hour session--after a 5-minute 10 puff use bout, and after the approximately 90 minute ad lib period.

Results for this outcome have not been posted.

Adverse events

Collected over During each of 6 approximately 4-hour session over up to a 3 week period.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cigarette Smokers0/12 (0%)0/12 (0%)0/12 (0%)
E-cigarette Users0/15 (0%)0/15 (0%)0/15 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cigarette SmokersE-cigarette UsersTotal
<=18 years000
Between 18 and 65 years121527
>=65 years000
Age, Continuous
Age, Continuous(years)Cigarette SmokersE-cigarette UsersTotal
Mean33.67 ± 8.7425.40 ± 7.9429.07 ± 9.15
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Cigarette SmokersE-cigarette UsersTotal
Female4711
Male7815
Other101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cigarette SmokersE-cigarette UsersTotal
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American426
White71118
More than one race000
Unknown or Not Reported112
Region of Enrollment
Region of Enrollment(participants)Cigarette SmokersE-cigarette UsersTotal
United States121527
08

Study locations

1 site
  • Clinical Behavioral Pharmacolgy Laboratory
    Richmond, Virginia 23298, United States
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · May 4, 2018
  • Informed consent form · Jun 17, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03710590
Lead sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Oct 18, 2018
Start date
Jan 15, 2019
Primary completion
Mar 9, 2020
Completion
Mar 9, 2020
Results posted
May 20, 2021
Last update
Oct 6, 2022

Study contacts

Alison Breland, PhD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vaping →

Other studies from this sponsor

Virginia Commonwealth University →

Start the discussion