Trial Outcomes & Findings for Assessment of Two New Electronic Cigarettes in Cigarette Smokers (NCT NCT03435562)
NCT ID: NCT03435562
Last Updated: 2020-08-03
Results Overview
Change in plasma nicotine level
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
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.
Results posted on
2020-08-03
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Two New Electronic Cigarettes in Cigarette Smokers
Baseline characteristics by cohort
| Measure |
Electronic Cigarette vs Own Brand Use
n=18 Participants
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.
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Age, Continuous
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36.8 years
STANDARD_DEVIATION 9.3 • n=99 Participants
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Sex: Female, Male
Female
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5 Participants
n=99 Participants
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Sex: Female, Male
Male
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13 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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15 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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7 Participants
n=99 Participants
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Race (NIH/OMB)
White
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8 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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2 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 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.Population: One participant was missing a sample so data was only available for 17 participants for these analyses.
Change in plasma nicotine level
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=17 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
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IQOS Electronic Cigarette Use
n=17 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
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Own Brand Cigarette Use
n=17 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Change in Plasma Nicotine
Post puff bout
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7.62 ng/ml
Standard Deviation 4.86
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10.65 ng/ml
Standard Deviation 6.20
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18.31 ng/ml
Standard Deviation 11.39
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Change in Plasma Nicotine
Post ad lib
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7.19 ng/ml
Standard Deviation 8.32
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5.97 ng/ml
Standard Deviation 7.70
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12.23 ng/ml
Standard Deviation 9.26
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SECONDARY outcome
Timeframe: 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.Carbon monoxide levels (in parts per mission)
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
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IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
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Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Carbon Monoxide Levels
Pre puff bout
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5.2 Parts per mission
Standard Deviation 2.4
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5.5 Parts per mission
Standard Deviation 2.4
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5.3 Parts per mission
Standard Deviation 2.0
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Carbon Monoxide Levels
Post puff bout
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8.7 Parts per mission
Standard Deviation 2.5
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5.1 Parts per mission
Standard Deviation 2.3
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4.9 Parts per mission
Standard Deviation 1.8
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Carbon Monoxide Levels
Pre ad lib
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8.8 Parts per mission
Standard Deviation 2.8
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5.3 Parts per mission
Standard Deviation 2.4
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4.6 Parts per mission
Standard Deviation 1.8
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Carbon Monoxide Levels
Post ad lib
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16.6 Parts per mission
Standard Deviation 7.0
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4.7 Parts per mission
Standard Deviation 1.9
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4.3 Parts per mission
Standard Deviation 1.4
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SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
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IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
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Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1
Pre puff bout
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24.8 score on a scale
Standard Deviation 8.2
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24.7 score on a scale
Standard Deviation 7.5
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25.1 score on a scale
Standard Deviation 8.2
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Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1
Post puff bout
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13.2 score on a scale
Standard Deviation 10.7
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20.1 score on a scale
Standard Deviation 9.3
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16.0 score on a scale
Standard Deviation 9.3
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Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1
Pre ad lib
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21.2 score on a scale
Standard Deviation 8.9
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21.7 score on a scale
Standard Deviation 9.3
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20.4 score on a scale
Standard Deviation 8.5
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Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1
Post ad lib
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11.5 score on a scale
Standard Deviation 10.2
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17.8 score on a scale
Standard Deviation 10.6
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14.4 score on a scale
Standard Deviation 9.7
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SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
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IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
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Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2
Pre puff bout
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11.7 score on a scale
Standard Deviation 8.3
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10.3 score on a scale
Standard Deviation 8.3
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12.5 score on a scale
Standard Deviation 8.4
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Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2
Post puff bout
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6.9 score on a scale
Standard Deviation 7.4
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8.1 score on a scale
Standard Deviation 7.8
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6.6 score on a scale
Standard Deviation 7.8
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Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2
Pre ad lib
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9.7 score on a scale
Standard Deviation 7.4
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9.5 score on a scale
Standard Deviation 7.5
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9.1 score on a scale
Standard Deviation 8.6
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Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2
Post ad lib
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5.5 score on a scale
Standard Deviation 7.6
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6.5 score on a scale
Standard Deviation 7.2
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6.6 score on a scale
Standard Deviation 8.9
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SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
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IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
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Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Hughes-Hatsukami Questionnaire - Anxious
Pre puff bout
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46.3 score on a scale
Standard Deviation 32.5
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42.8 score on a scale
Standard Deviation 31.9
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44.5 score on a scale
Standard Deviation 34.9
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Hughes-Hatsukami Questionnaire - Anxious
Post puff bout
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24.8 score on a scale
Standard Deviation 30.6
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24.4 score on a scale
Standard Deviation 31.8
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28.4 score on a scale
Standard Deviation 33.9
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Hughes-Hatsukami Questionnaire - Anxious
Pre ad lib
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22.1 score on a scale
Standard Deviation 22.8
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20.8 score on a scale
Standard Deviation 30.1
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17.2 score on a scale
Standard Deviation 27.2
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Hughes-Hatsukami Questionnaire - Anxious
Post ad lib
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19.4 score on a scale
Standard Deviation 27.5
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20.4 score on a scale
Standard Deviation 27
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28.4 score on a scale
Standard Deviation 32.6
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SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
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IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
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Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Hughes-Hatsukami Questionnaire - Craving
Pre puff bout
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75.2 points on a scale
Standard Deviation 30.7
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70.5 points on a scale
Standard Deviation 30.9
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73.5 points on a scale
Standard Deviation 33.5
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Hughes-Hatsukami Questionnaire - Craving
Post puff bout
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34.9 points on a scale
Standard Deviation 35
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49.3 points on a scale
Standard Deviation 36.0
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42.9 points on a scale
Standard Deviation 31.8
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Hughes-Hatsukami Questionnaire - Craving
Pre ad lib
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55.2 points on a scale
Standard Deviation 30.5
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54.0 points on a scale
Standard Deviation 38
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53.8 points on a scale
Standard Deviation 29.9
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Hughes-Hatsukami Questionnaire - Craving
Post ad lib
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25.5 points on a scale
Standard Deviation 29.2
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53.9 points on a scale
Standard Deviation 34.9
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36.2 points on a scale
Standard Deviation 32.1
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SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
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Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Hughes-Hatsukami Questionnaire - Depression
Pre puff bout
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21.4 points on a scale
Standard Deviation 28.3
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15.1 points on a scale
Standard Deviation 20.9
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20.5 points on a scale
Standard Deviation 26.1
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Hughes-Hatsukami Questionnaire - Depression
Post puff bout
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9.8 points on a scale
Standard Deviation 16.8
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8.8 points on a scale
Standard Deviation 16.6
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15.1 points on a scale
Standard Deviation 22.6
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Hughes-Hatsukami Questionnaire - Depression
Pre ad lib
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11.5 points on a scale
Standard Deviation 21.5
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8.1 points on a scale
Standard Deviation 17.0
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10.6 points on a scale
Standard Deviation 20.1
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Hughes-Hatsukami Questionnaire - Depression
Post ad lib
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8.8 points on a scale
Standard Deviation 13.6
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8.2 points on a scale
Standard Deviation 16.3
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11.5 points on a scale
Standard Deviation 21.7
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SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
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IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
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Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Hughes-Hatsukami Questionnaire - Difficulty Concentrating
Pre puff bout
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28.2 points on a scale
Standard Deviation 26.4
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37.6 points on a scale
Standard Deviation 30.1
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30.0 points on a scale
Standard Deviation 31.9
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Hughes-Hatsukami Questionnaire - Difficulty Concentrating
Post puff bout
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18.5 points on a scale
Standard Deviation 20.4
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17.3 points on a scale
Standard Deviation 19.9
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24.4 points on a scale
Standard Deviation 29.9
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Hughes-Hatsukami Questionnaire - Difficulty Concentrating
Pre ad lib
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18.1 points on a scale
Standard Deviation 20.8
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15.5 points on a scale
Standard Deviation 22.5
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16.8 points on a scale
Standard Deviation 20.6
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Hughes-Hatsukami Questionnaire - Difficulty Concentrating
Post ad lib
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10.4 points on a scale
Standard Deviation 18.1
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17.8 points on a scale
Standard Deviation 25.8
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18.9 points on a scale
Standard Deviation 27.0
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SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
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Hughes-Hatsukami Questionnaire - Drowsy
Pre puff bout
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35.2 points on a scale
Standard Deviation 25
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33.8 points on a scale
Standard Deviation 28.2
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31.9 points on a scale
Standard Deviation 33.9
|
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Hughes-Hatsukami Questionnaire - Drowsy
Post puff bout
|
28.7 points on a scale
Standard Deviation 26.1
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21.4 points on a scale
Standard Deviation 24.6
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29.4 points on a scale
Standard Deviation 26.5
|
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Hughes-Hatsukami Questionnaire - Drowsy
Pre ad lib
|
24.9 points on a scale
Standard Deviation 24.3
|
25.9 points on a scale
Standard Deviation 31.1
|
23.4 points on a scale
Standard Deviation 24.6
|
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Hughes-Hatsukami Questionnaire - Drowsy
Post ad lib
|
23.4 points on a scale
Standard Deviation 26.9
|
25.3 points on a scale
Standard Deviation 27.0
|
27.4 points on a scale
Standard Deviation 29.8
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
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Hughes-Hatsukami Questionnaire - Hunger
Pre puff bout
|
39.9 points on a scale
Standard Deviation 22.7
|
43.2 points on a scale
Standard Deviation 29.8
|
43.0 points on a scale
Standard Deviation 35.5
|
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Hughes-Hatsukami Questionnaire - Hunger
Post puff bout
|
31.9 points on a scale
Standard Deviation 24.4
|
35.6 points on a scale
Standard Deviation 33.3
|
30.2 points on a scale
Standard Deviation 25.5
|
|
Hughes-Hatsukami Questionnaire - Hunger
Pre ad lib
|
34.8 points on a scale
Standard Deviation 25.9
|
39.5 points on a scale
Standard Deviation 35.9
|
37.7 points on a scale
Standard Deviation 29.0
|
|
Hughes-Hatsukami Questionnaire - Hunger
Post ad lib
|
39.8 points on a scale
Standard Deviation 30.7
|
58.4 points on a scale
Standard Deviation 29.0
|
53.2 points on a scale
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Hughes-Hatsukami Questionnaire - Impatient
Pre puff bout
|
42.1 points on a scale
Standard Deviation 28.3
|
41.0 points on a scale
Standard Deviation 30.6
|
51.4 points on a scale
Standard Deviation 31.0
|
|
Hughes-Hatsukami Questionnaire - Impatient
Post puff bout
|
23.9 points on a scale
Standard Deviation 27.3
|
25.9 points on a scale
Standard Deviation 31.0
|
25.1 points on a scale
Standard Deviation 30.9
|
|
Hughes-Hatsukami Questionnaire - Impatient
Pre ad lib
|
26.9 points on a scale
Standard Deviation 29.3
|
31.4 points on a scale
Standard Deviation 28.9
|
29.7 points on a scale
Standard Deviation 30.3
|
|
Hughes-Hatsukami Questionnaire - Impatient
Post ad lib
|
25.5 points on a scale
Standard Deviation 28.2
|
31.8 points on a scale
Standard Deviation 30.5
|
27.2 points on a scale
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Hughes-Hatsukami Questionnaire - Irritable
Pre puff bout
|
37.4 points on a scale
Standard Deviation 31.0
|
34.5 points on a scale
Standard Deviation 31.1
|
38.7 points on a scale
Standard Deviation 33.3
|
|
Hughes-Hatsukami Questionnaire - Irritable
Post puff bout
|
14.9 points on a scale
Standard Deviation 17.2
|
18.4 points on a scale
Standard Deviation 22.1
|
19.8 points on a scale
Standard Deviation 26.3
|
|
Hughes-Hatsukami Questionnaire - Irritable
Pre ad lib
|
14.1 points on a scale
Standard Deviation 16.0
|
15.4 points on a scale
Standard Deviation 22.3
|
16.8 points on a scale
Standard Deviation 21.0
|
|
Hughes-Hatsukami Questionnaire - Irritable
Post ad lib
|
14.6 points on a scale
Standard Deviation 22.0
|
15.1 points on a scale
Standard Deviation 26.4
|
16.8 points on a scale
Standard Deviation 24.1
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Hughes-Hatsukami Questionnaire - Restless
Pre puff bout
|
40.8 points on a scale
Standard Deviation 29.4
|
30.2 points on a scale
Standard Deviation 25.5
|
28.9 points on a scale
Standard Deviation 31.8
|
|
Hughes-Hatsukami Questionnaire - Restless
Post puff bout
|
19.7 points on a scale
Standard Deviation 24.8
|
26.9 points on a scale
Standard Deviation 25.9
|
19.7 points on a scale
Standard Deviation 24.6
|
|
Hughes-Hatsukami Questionnaire - Restless
Pre ad lib
|
27.7 points on a scale
Standard Deviation 27.2
|
17.9 points on a scale
Standard Deviation 25.7
|
33.4 points on a scale
Standard Deviation 31.4
|
|
Hughes-Hatsukami Questionnaire - Restless
Post ad lib
|
21.5 points on a scale
Standard Deviation 28.1
|
24.7 points on a scale
Standard Deviation 27.6
|
27.1 points on a scale
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Hughes-Hatsukami Questionnaire - Desire for Sweets
Pre puff bout
|
24.2 points on a scale
Standard Deviation 30.7
|
27.4 points on a scale
Standard Deviation 33.3
|
24.8 points on a scale
Standard Deviation 28.3
|
|
Hughes-Hatsukami Questionnaire - Desire for Sweets
Post puff bout
|
16.8 points on a scale
Standard Deviation 21.4
|
20.3 points on a scale
Standard Deviation 27.2
|
16.4 points on a scale
Standard Deviation 25.7
|
|
Hughes-Hatsukami Questionnaire - Desire for Sweets
Pre ad lib
|
18.8 points on a scale
Standard Deviation 25.8
|
20.7 points on a scale
Standard Deviation 28.1
|
23.8 points on a scale
Standard Deviation 27.9
|
|
Hughes-Hatsukami Questionnaire - Desire for Sweets
Post ad lib
|
17.9 points on a scale
Standard Deviation 21.3
|
17.4 points on a scale
Standard Deviation 24.0
|
20.5 points on a scale
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Hughes-Hatsukami Questionnaire - Urge to Smoke
Pre puff bout
|
76.5 points on a scale
Standard Deviation 25.2
|
67.2 points on a scale
Standard Deviation 29.9
|
74.7 points on a scale
Standard Deviation 31.5
|
|
Hughes-Hatsukami Questionnaire - Urge to Smoke
Post puff bout
|
39.2 points on a scale
Standard Deviation 34.8
|
48.8 points on a scale
Standard Deviation 31.9
|
46.2 points on a scale
Standard Deviation 29.5
|
|
Hughes-Hatsukami Questionnaire - Urge to Smoke
Pre ad lib
|
54.4 points on a scale
Standard Deviation 27.6
|
46.9 points on a scale
Standard Deviation 33.3
|
56.9 points on a scale
Standard Deviation 27.8
|
|
Hughes-Hatsukami Questionnaire - Urge to Smoke
Post ad lib
|
24.9 points on a scale
Standard Deviation 25.7
|
50.0 points on a scale
Standard Deviation 31.1
|
38 points on a scale
Standard Deviation 31.8
|
SECONDARY outcome
Timeframe: 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.One question is used to assess how much product use makes participants feel awake, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Nicotine Questionnaire - Awake
Post puff bout
|
40.9 score on a question
Standard Deviation 31.7
|
33.8 score on a question
Standard Deviation 29.9
|
36.5 score on a question
Standard Deviation 30.6
|
|
Direct Effects of Nicotine Questionnaire - Awake
Post ad lib
|
45.1 score on a question
Standard Deviation 31.3
|
28.1 score on a question
Standard Deviation 29.6
|
34.5 score on a question
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: 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.One question is used to assess how much product use makes participants feel calm, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Nicotine Questionnaire - Calm
Post puff bout
|
60.9 score on a question
Standard Deviation 36
|
47.9 score on a question
Standard Deviation 31.9
|
54.4 score on a question
Standard Deviation 31.5
|
|
Direct Effects of Nicotine Questionnaire - Calm
Post ad lib
|
60.7 score on a question
Standard Deviation 35.3
|
46.6 score on a question
Standard Deviation 29.7
|
43.2 score on a question
Standard Deviation 34.5
|
SECONDARY outcome
Timeframe: 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.One question is used to assess how much product use helps participants concentrate, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Nicotine Questionnaire - Concentrate
Post puff bout
|
34.8 score on a question
Standard Deviation 30.8
|
24.5 score on a question
Standard Deviation 26.3
|
38.5 score on a question
Standard Deviation 33.7
|
|
Direct Effects of Nicotine Questionnaire - Concentrate
Post ad lib
|
42.0 score on a question
Standard Deviation 34.3
|
27.5 score on a question
Standard Deviation 26.3
|
27.8 score on a question
Standard Deviation 27.1
|
SECONDARY outcome
Timeframe: 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.One question is used to assess how much product use makes participants feel dizzy, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Nicotine Questionnaire - Dizzy
Post puff bout
|
40.7 score on a question
Standard Deviation 33.4
|
33.7 score on a question
Standard Deviation 33.5
|
36.4 score on a question
Standard Deviation 33.7
|
|
Direct Effects of Nicotine Questionnaire - Dizzy
Post ad lib
|
30.1 score on a question
Standard Deviation 36.2
|
19.4 score on a question
Standard Deviation 27.2
|
26.9 score on a question
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: 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.One question is used to assess how much product use reduces feeling of hunger, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Nicotine Questionnaire - Reduce Hunger
Post puff bout
|
41.9 score on a question
Standard Deviation 29.9
|
35.2 score on a question
Standard Deviation 27.4
|
29.2 score on a question
Standard Deviation 28.8
|
|
Direct Effects of Nicotine Questionnaire - Reduce Hunger
Post ad lib
|
33.0 score on a question
Standard Deviation 27.7
|
37.1 score on a question
Standard Deviation 31.0
|
34.3 score on a question
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: 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.One question is used to assess how much product use makes participants feel sick, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Nicotine Questionnaire - Sick
Post puff bout
|
4.1 score on a question
Standard Deviation 7.5
|
8.1 score on a question
Standard Deviation 14.2
|
9.5 score on a question
Standard Deviation 19.0
|
|
Direct Effects of Nicotine Questionnaire - Sick
Post ad lib
|
2.6 score on a question
Standard Deviation 5.2
|
7.8 score on a question
Standard Deviation 14.4
|
10.5 score on a question
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: 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.A single question is used to assess if product use felt pleasant, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Product Use Questionnaire - Pleasant
Post puff bout
|
81.4 score on a question
Standard Deviation 29.8
|
50.4 score on a question
Standard Deviation 31.6
|
58.8 score on a question
Standard Deviation 36.0
|
|
Direct Effects of Product Use Questionnaire - Pleasant
Post ad lib
|
81.9 score on a question
Standard Deviation 24.9
|
50.6 score on a question
Standard Deviation 31.2
|
58.9 score on a question
Standard Deviation 34.4
|
SECONDARY outcome
Timeframe: 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.A single question is used to assess if product use tasted good, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Product Use Questionnaire - Taste Good
Post puff bout
|
77.7 score on a question
Standard Deviation 29.5
|
50.5 score on a question
Standard Deviation 32.6
|
54.6 score on a question
Standard Deviation 36.4
|
|
Direct Effects of Product Use Questionnaire - Taste Good
Post ad lib
|
74.0 score on a question
Standard Deviation 32.1
|
51.2 score on a question
Standard Deviation 30.7
|
49.8 score on a question
Standard Deviation 35.7
|
SECONDARY outcome
Timeframe: 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.A single question is used to assess if product use felt satisfying, and is scored 0 (not at all) to 100 (extremely).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Product Use Questionnaire - Satisfying
Post puff bout
|
84.3 score on a question
Standard Deviation 24.4
|
47.0 score on a question
Standard Deviation 33.2
|
58.8 score on a question
Standard Deviation 30.9
|
|
Direct Effects of Product Use Questionnaire - Satisfying
Post ad lib
|
83.7 score on a question
Standard Deviation 24.5
|
46.5 score on a question
Standard Deviation 31.5
|
58.8 score on a question
Standard Deviation 33.3
|
SECONDARY outcome
Timeframe: 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.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).
Outcome measures
| Measure |
JUUL Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
JUUL electronic cigarette: Effects of JUUL electronic cigarette use.
|
IQOS Electronic Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
IQOS electronic cigarette: Effects of IQOS electronic cigarette use.
|
Own Brand Cigarette Use
n=18 Participants
During each 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 (each session will be approximately 3 hours).
Own Brand cigarette: Effects of own brand cigarette use.
|
|---|---|---|---|
|
Direct Effects of Product Use Questionnaire - Smoke Right Now
Post puff bout
|
62.8 score on a question
Standard Deviation 37.7
|
45.4 score on a question
Standard Deviation 32.7
|
47.2 score on a question
Standard Deviation 39.1
|
|
Direct Effects of Product Use Questionnaire - Smoke Right Now
Post ad lib
|
44.1 score on a question
Standard Deviation 37.7
|
35.5 score on a question
Standard Deviation 29.1
|
37.5 score on a question
Standard Deviation 33.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Heat rate will be measured from baseline continuously throughout each each approximately 4-hr sessionChange in heart rate, measured in beats per minute
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood pressure will be measured from baseline continuously throughout each approximately 4-hr sessionChange in blood pressure, measured in mm/hg
Outcome measures
Outcome data not reported
Adverse Events
JUUL Electronic Cigarette Use
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IQOS Electronic Cigarette Use
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Own Brand Cigarette Use
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place