ClinicalTrials.gg
CompletedNCT03435562Updated Aug 3, 2020Results posted

Assessment of Two New Electronic Cigarettes in Cigarette Smokers

An interventional study of JUUL electronic cigarette and IQOS electronic cigarette in Electronic Cigarettes, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-03.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Other

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Phase
Not applicable
Study type
Interventional
Enrollment
22
Ages
21 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 14 studies in Vaping by Virginia Commonwealth University — none open to participants now, none under way, none of them phase 3. Vaping · Virginia Commonwealth University.

Enrollment
8th of 13
22 · median 32
Started
2018
the only one that year
No phase
12 of 14
none open now
Registered
1st of 14
by date

Among the 14 studies in Vaping by Virginia Commonwealth University, this one is the 8th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 12 with no phase, and was the 1st registered.

Vaping

402 studies on the registry are indexed under Vaping; 96 are open to participants now.

Browse Vaping studies →

Open to participants now

None of the 14 studies in Vaping by Virginia Commonwealth University is open now. The open studies under Vaping, anywhere →

Where they have run

Who these studies take

Of the 64 Vaping studies recruiting now, 32 (50%) set no upper age limit and 31 (48%) stop at 75 or younger; 13 take children under 18; 40 take healthy volunteers.

This study: 21 Years to 55 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 14 studies in Vaping by Virginia Commonwealth University as a file.
02

Study summary

The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use an two new electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of cigarettes.

03

Conditions studied

  • Electronic Cigarettes

Browse trials for

04

Who can participate

Ages eligible
21 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
  • able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
  • cigarette smokers

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    electronic cigarette vs own brand use

    Participants will come in for three session. During one session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (the session will be approximately 3 hours). The order of the sessions will be determined randomly and data about session will not be recorded or used in the analysis.

    Other: JUUL electronic cigarette · Other: IQOS electronic cigarette · Other: Own Brand cigarette

Interventions

  • OtherJUUL electronic cigarette

    Effects of JUUL electronic cigarette use.

  • OtherIQOS electronic cigarette

    Effects of IQOS electronic cigarette use.

  • OtherOwn Brand cigarette

    Effects of own brand cigarette use.

06

What researchers measure

Primary outcomes

  1. Change in Plasma Nicotine

    Change in plasma nicotine level

    Time frame: Blood will be taken 4 times in each session: at baseline, 5 min after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.

Secondary outcomes

  1. Carbon Monoxide Levels

    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.

  2. Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1

    This scale is used to assess the extent to which product use reduces the intention to smoke a cigarette, and consists of 5 items that are scored 0 - 7, in which participants clicked seven discrete ratings from 'not at all' to 'extremely'. The items are summed and scores range from 0 to 30 with higher scores indicating higher craving for a cigarette.

    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.

  3. Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2

    This scale is used to assess the extent to which product use reduces the intention to smoke a cigarette, and consists of 4 items that are scored 0 - 7, in which participants clicked seven discrete ratings from 'not at all' to 'extremely'. The items are summed and scores range from 0 to 24 with higher scores indicating higher craving for a cigarette.

    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. Hughes-Hatsukami Questionnaire - Anxious

    This scale is used to assess the extent to which product use affects on anxiety and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  5. Hughes-Hatsukami Questionnaire - Craving

    This scale is used to assess the extent to which product use affects on craving a cigarette and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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. Hughes-Hatsukami Questionnaire - Depression

    This scale is used to assess the extent to which product use affects on depression and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  7. Hughes-Hatsukami Questionnaire - Difficulty Concentrating

    This scale is used to assess the extent to which product use affects having difficulty concentrating and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  8. Hughes-Hatsukami Questionnaire - Drowsy

    This scale is used to assess the extent to which product use affects feeling drowsy and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  9. Hughes-Hatsukami Questionnaire - Hunger

    This scale is used to assess the extent to which product use affects reducing hunger and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  10. Hughes-Hatsukami Questionnaire - Impatient

    This scale is used to assess the extent to which product use affects feeling impatient and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  11. Hughes-Hatsukami Questionnaire - Irritable

    This scale is used to assess the extent to which product use affects feeling irritable and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  12. Hughes-Hatsukami Questionnaire - Restless

    This scale is used to assess the extent to which product use affects feeling restless and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  13. Hughes-Hatsukami Questionnaire - Desire for Sweets

    This scale is used to assess the extent to which product use affects having desire for sweets and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  14. Hughes-Hatsukami Questionnaire - Urge to Smoke

    This scale is used to assess the extent to which product use affects having the urge to smoke and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

    Time frame: Questionnaire will be administered 4 times in 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.

  15. Direct Effects of Nicotine Questionnaire - Awake

    One question is used to assess how much product use makes participants feel awake, and is scored 0 (not at all) to 100 (extremely).

    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.

  16. Direct Effects of Nicotine Questionnaire - Calm

    One question is used to assess how much product use makes participants feel calm, and is scored 0 (not at all) to 100 (extremely).

    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.

  17. Direct Effects of Nicotine Questionnaire - Concentrate

    One question is used to assess how much product use helps participants concentrate, and is scored 0 (not at all) to 100 (extremely).

    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.

  18. Direct Effects of Nicotine Questionnaire - Dizzy

    One question is used to assess how much product use makes participants feel dizzy, and is scored 0 (not at all) to 100 (extremely).

    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.

  19. Direct Effects of Nicotine Questionnaire - Reduce Hunger

    One question is used to assess how much product use reduces feeling of hunger, and is scored 0 (not at all) to 100 (extremely).

    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.

  20. Direct Effects of Nicotine Questionnaire - Sick

    One question is used to assess how much product use makes participants feel sick, and is scored 0 (not at all) to 100 (extremely).

    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.

  21. Direct Effects of Product Use Questionnaire - Pleasant

    A single question is used to assess if product use felt pleasant, and is scored 0 (not at all) to 100 (extremely).

    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 approxiamtely 1-hour ad lib use period.

  22. Direct Effects of Product Use Questionnaire - Taste Good

    A single question is used to assess if product use tasted good, and is scored 0 (not at all) to 100 (extremely).

    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 approxiamtely 1-hour ad lib use period.

  23. Direct Effects of Product Use Questionnaire - Satisfying

    A single question is used to assess if product use felt satisfying, and is scored 0 (not at all) to 100 (extremely).

    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 approxiamtely 1-hour ad lib use period.

  24. Direct Effects of Product Use Questionnaire - Smoke Right Now

    A single question is used to assess if product use made them want to use the product again right now, and is scored 0 (not at all) to 100 (extremely).

    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 approxiamtely 1-hour ad lib use period.

Other outcomes

  1. Heart Rate

    Change in heart rate, measured in beats per minute

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

  2. 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

07

Results

Posted Aug 3, 2020

Participant flow

Participant flow — Overall Study
MilestoneElectronic Cigarette vs Own Brand Use
Started22
Completed18
Not completed4

Outcome measures

PrimaryChange in Plasma Nicotine

Change in plasma nicotine level

Time frame:
Blood will be taken 4 times in each session: at baseline, 5 min after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Reported as:
Mean · ng/ml
Change in Plasma Nicotine
ng/mlJUUL Electronic Cigarette UseIQOS Electronic Cigarette UseOwn Brand Cigarette Use
Post puff bout7.62 ± 4.8610.65 ± 6.2018.31 ± 11.39
Post ad lib7.19 ± 8.325.97 ± 7.7012.23 ± 9.26
SecondaryCarbon Monoxide Levels

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.
Reported as:
Mean · Parts per mission
Carbon Monoxide Levels
Parts per missionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout5.2 ± 2.45.5 ± 2.45.3 ± 2.0
Post puff bout8.7 ± 2.55.1 ± 2.34.9 ± 1.8
Pre ad lib8.8 ± 2.85.3 ± 2.44.6 ± 1.8
Post ad lib16.6 ± 7.04.7 ± 1.94.3 ± 1.4
SecondaryTiffany-Drobes Questionnaire of Smoking Urges - Factor 1

This scale is used to assess the extent to which product use reduces the intention to smoke a cigarette, and consists of 5 items that are scored 0 - 7, in which participants clicked seven discrete ratings from 'not at all' to 'extremely'. The items are summed and scores range from 0 to 30 with higher scores indicating higher craving for a cigarette.

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.
Reported as:
Mean · score on a scale
Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1
score on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout24.8 ± 8.224.7 ± 7.525.1 ± 8.2
Post puff bout13.2 ± 10.720.1 ± 9.316.0 ± 9.3
Pre ad lib21.2 ± 8.921.7 ± 9.320.4 ± 8.5
Post ad lib11.5 ± 10.217.8 ± 10.614.4 ± 9.7
SecondaryTiffany-Drobes Questionnaire of Smoking Urges - Factor 2

This scale is used to assess the extent to which product use reduces the intention to smoke a cigarette, and consists of 4 items that are scored 0 - 7, in which participants clicked seven discrete ratings from 'not at all' to 'extremely'. The items are summed and scores range from 0 to 24 with higher scores indicating higher craving for a cigarette.

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.
Reported as:
Mean · score on a scale
Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2
score on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout11.7 ± 8.310.3 ± 8.312.5 ± 8.4
Post puff bout6.9 ± 7.48.1 ± 7.86.6 ± 7.8
Pre ad lib9.7 ± 7.49.5 ± 7.59.1 ± 8.6
Post ad lib5.5 ± 7.66.5 ± 7.26.6 ± 8.9
SecondaryHughes-Hatsukami Questionnaire - Anxious

This scale is used to assess the extent to which product use affects on anxiety and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · score on a scale
Hughes-Hatsukami Questionnaire - Anxious
score on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout46.3 ± 32.542.8 ± 31.944.5 ± 34.9
Post puff bout24.8 ± 30.624.4 ± 31.828.4 ± 33.9
Pre ad lib22.1 ± 22.820.8 ± 30.117.2 ± 27.2
Post ad lib19.4 ± 27.520.4 ± 2728.4 ± 32.6
SecondaryHughes-Hatsukami Questionnaire - Craving

This scale is used to assess the extent to which product use affects on craving a cigarette and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Craving
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout75.2 ± 30.770.5 ± 30.973.5 ± 33.5
Post puff bout34.9 ± 3549.3 ± 36.042.9 ± 31.8
Pre ad lib55.2 ± 30.554.0 ± 3853.8 ± 29.9
Post ad lib25.5 ± 29.253.9 ± 34.936.2 ± 32.1
SecondaryHughes-Hatsukami Questionnaire - Depression

This scale is used to assess the extent to which product use affects on depression and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Depression
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout21.4 ± 28.315.1 ± 20.920.5 ± 26.1
Post puff bout9.8 ± 16.88.8 ± 16.615.1 ± 22.6
Pre ad lib11.5 ± 21.58.1 ± 17.010.6 ± 20.1
Post ad lib8.8 ± 13.68.2 ± 16.311.5 ± 21.7
SecondaryHughes-Hatsukami Questionnaire - Difficulty Concentrating

This scale is used to assess the extent to which product use affects having difficulty concentrating and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Difficulty Concentrating
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout28.2 ± 26.437.6 ± 30.130.0 ± 31.9
Post puff bout18.5 ± 20.417.3 ± 19.924.4 ± 29.9
Pre ad lib18.1 ± 20.815.5 ± 22.516.8 ± 20.6
Post ad lib10.4 ± 18.117.8 ± 25.818.9 ± 27.0
SecondaryHughes-Hatsukami Questionnaire - Drowsy

This scale is used to assess the extent to which product use affects feeling drowsy and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Drowsy
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout35.2 ± 2533.8 ± 28.231.9 ± 33.9
Post puff bout28.7 ± 26.121.4 ± 24.629.4 ± 26.5
Pre ad lib24.9 ± 24.325.9 ± 31.123.4 ± 24.6
Post ad lib23.4 ± 26.925.3 ± 27.027.4 ± 29.8
SecondaryHughes-Hatsukami Questionnaire - Hunger

This scale is used to assess the extent to which product use affects reducing hunger and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Hunger
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout39.9 ± 22.743.2 ± 29.843.0 ± 35.5
Post puff bout31.9 ± 24.435.6 ± 33.330.2 ± 25.5
Pre ad lib34.8 ± 25.939.5 ± 35.937.7 ± 29.0
Post ad lib39.8 ± 30.758.4 ± 29.053.2 ± 31.9
SecondaryHughes-Hatsukami Questionnaire - Impatient

This scale is used to assess the extent to which product use affects feeling impatient and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Impatient
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout42.1 ± 28.341.0 ± 30.651.4 ± 31.0
Post puff bout23.9 ± 27.325.9 ± 31.025.1 ± 30.9
Pre ad lib26.9 ± 29.331.4 ± 28.929.7 ± 30.3
Post ad lib25.5 ± 28.231.8 ± 30.527.2 ± 27.0
SecondaryHughes-Hatsukami Questionnaire - Irritable

This scale is used to assess the extent to which product use affects feeling irritable and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Irritable
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout37.4 ± 31.034.5 ± 31.138.7 ± 33.3
Post puff bout14.9 ± 17.218.4 ± 22.119.8 ± 26.3
Pre ad lib14.1 ± 16.015.4 ± 22.316.8 ± 21.0
Post ad lib14.6 ± 22.015.1 ± 26.416.8 ± 24.1
SecondaryHughes-Hatsukami Questionnaire - Restless

This scale is used to assess the extent to which product use affects feeling restless and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Restless
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout40.8 ± 29.430.2 ± 25.528.9 ± 31.8
Post puff bout19.7 ± 24.826.9 ± 25.919.7 ± 24.6
Pre ad lib27.7 ± 27.217.9 ± 25.733.4 ± 31.4
Post ad lib21.5 ± 28.124.7 ± 27.627.1 ± 28.4
SecondaryHughes-Hatsukami Questionnaire - Desire for Sweets

This scale is used to assess the extent to which product use affects having desire for sweets and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Desire for Sweets
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout24.2 ± 30.727.4 ± 33.324.8 ± 28.3
Post puff bout16.8 ± 21.420.3 ± 27.216.4 ± 25.7
Pre ad lib18.8 ± 25.820.7 ± 28.123.8 ± 27.9
Post ad lib17.9 ± 21.317.4 ± 24.020.5 ± 27.0
SecondaryHughes-Hatsukami Questionnaire - Urge to Smoke

This scale is used to assess the extent to which product use affects having the urge to smoke and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

Time frame:
Questionnaire will be administered 4 times in 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.
Reported as:
Mean · points on a scale
Hughes-Hatsukami Questionnaire - Urge to Smoke
points on a scaleOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Pre puff bout76.5 ± 25.267.2 ± 29.974.7 ± 31.5
Post puff bout39.2 ± 34.848.8 ± 31.946.2 ± 29.5
Pre ad lib54.4 ± 27.646.9 ± 33.356.9 ± 27.8
Post ad lib24.9 ± 25.750.0 ± 31.138 ± 31.8
SecondaryDirect Effects of Nicotine Questionnaire - Awake

One question is used to assess how much product use makes participants feel awake, and is scored 0 (not at all) to 100 (extremely).

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.
Reported as:
Mean · score on a question
Direct Effects of Nicotine Questionnaire - Awake
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout40.9 ± 31.733.8 ± 29.936.5 ± 30.6
Post ad lib45.1 ± 31.328.1 ± 29.634.5 ± 27.4
SecondaryDirect Effects of Nicotine Questionnaire - Calm

One question is used to assess how much product use makes participants feel calm, and is scored 0 (not at all) to 100 (extremely).

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.
Reported as:
Mean · score on a question
Direct Effects of Nicotine Questionnaire - Calm
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout60.9 ± 3647.9 ± 31.954.4 ± 31.5
Post ad lib60.7 ± 35.346.6 ± 29.743.2 ± 34.5
SecondaryDirect Effects of Nicotine Questionnaire - Concentrate

One question is used to assess how much product use helps participants concentrate, and is scored 0 (not at all) to 100 (extremely).

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.
Reported as:
Mean · score on a question
Direct Effects of Nicotine Questionnaire - Concentrate
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout34.8 ± 30.824.5 ± 26.338.5 ± 33.7
Post ad lib42.0 ± 34.327.5 ± 26.327.8 ± 27.1
SecondaryDirect Effects of Nicotine Questionnaire - Dizzy

One question is used to assess how much product use makes participants feel dizzy, and is scored 0 (not at all) to 100 (extremely).

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.
Reported as:
Mean · score on a question
Direct Effects of Nicotine Questionnaire - Dizzy
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout40.7 ± 33.433.7 ± 33.536.4 ± 33.7
Post ad lib30.1 ± 36.219.4 ± 27.226.9 ± 25.8
SecondaryDirect Effects of Nicotine Questionnaire - Reduce Hunger

One question is used to assess how much product use reduces feeling of hunger, and is scored 0 (not at all) to 100 (extremely).

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.
Reported as:
Mean · score on a question
Direct Effects of Nicotine Questionnaire - Reduce Hunger
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout41.9 ± 29.935.2 ± 27.429.2 ± 28.8
Post ad lib33.0 ± 27.737.1 ± 31.034.3 ± 26.1
SecondaryDirect Effects of Nicotine Questionnaire - Sick

One question is used to assess how much product use makes participants feel sick, and is scored 0 (not at all) to 100 (extremely).

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.
Reported as:
Mean · score on a question
Direct Effects of Nicotine Questionnaire - Sick
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout4.1 ± 7.58.1 ± 14.29.5 ± 19.0
Post ad lib2.6 ± 5.27.8 ± 14.410.5 ± 16.8
SecondaryDirect Effects of Product Use Questionnaire - Pleasant

A single question is used to assess if product use felt pleasant, and is scored 0 (not at all) to 100 (extremely).

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 approxiamtely 1-hour ad lib use period.
Reported as:
Mean · score on a question
Direct Effects of Product Use Questionnaire - Pleasant
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout81.4 ± 29.850.4 ± 31.658.8 ± 36.0
Post ad lib81.9 ± 24.950.6 ± 31.258.9 ± 34.4
SecondaryDirect Effects of Product Use Questionnaire - Taste Good

A single question is used to assess if product use tasted good, and is scored 0 (not at all) to 100 (extremely).

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 approxiamtely 1-hour ad lib use period.
Reported as:
Mean · score on a question
Direct Effects of Product Use Questionnaire - Taste Good
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout77.7 ± 29.550.5 ± 32.654.6 ± 36.4
Post ad lib74.0 ± 32.151.2 ± 30.749.8 ± 35.7
SecondaryDirect Effects of Product Use Questionnaire - Satisfying

A single question is used to assess if product use felt satisfying, and is scored 0 (not at all) to 100 (extremely).

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 approxiamtely 1-hour ad lib use period.
Reported as:
Mean · score on a question
Direct Effects of Product Use Questionnaire - Satisfying
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout84.3 ± 24.447.0 ± 33.258.8 ± 30.9
Post ad lib83.7 ± 24.546.5 ± 31.558.8 ± 33.3
SecondaryDirect Effects of Product Use Questionnaire - Smoke Right Now

A single question is used to assess if product use made them want to use the product again right now, and is scored 0 (not at all) to 100 (extremely).

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 approxiamtely 1-hour ad lib use period.
Reported as:
Mean · score on a question
Direct Effects of Product Use Questionnaire - Smoke Right Now
score on a questionOwn Brand Cigarette UseJUUL Electronic Cigarette UseIQOS Electronic Cigarette Use
Post puff bout62.8 ± 37.745.4 ± 32.747.2 ± 39.1
Post ad lib44.1 ± 37.735.5 ± 29.137.5 ± 33.5
Other pre-specifiedHeart Rate

Change in heart rate, measured in beats per minute

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

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.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
JUUL Electronic Cigarette Use———
IQOS Electronic Cigarette Use———
Own Brand Cigarette Use———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Electronic Cigarette vs Own Brand Use
Mean36.8 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Electronic Cigarette vs Own Brand Use
Female5
Male13
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Electronic Cigarette vs Own Brand Use
Hispanic or Latino1
Not Hispanic or Latino15
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Electronic Cigarette vs Own Brand Use
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American7
White8
More than one race2
Unknown or Not Reported1
08

Study locations

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

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Aug 2019, 17 months.

Results were first posted in Aug 2020, 11 months after primary completion.

Of 184 non-industry interventional studies with no phase under Vaping, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's 17 months is below that.

Counting every sponsor, half of 208 studies reached it within 18 months; a quarter within 6 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2018
First posted
Feb 19, 2018
StartActual
Mar 3, 2018
Primary completionActual
Aug 16, 2019
CompletionActual
Aug 16, 2019
Results first posted
Aug 3, 2020
Last update
Aug 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03435562
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Mar 3, 2018
Primary completion
Aug 16, 2019
Completion
Aug 16, 2019
Results posted
Aug 3, 2020
Last update
Aug 3, 2020

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 ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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