Electronic Cigarettes
Conditions
Brief 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.
Interventions
Effects of JUUL electronic cigarette use.
OTHERIQOS electronic cigarette
Effects of IQOS electronic cigarette use.
OTHEROwn Brand cigarette
Effects of own brand cigarette use.
Sponsors
Virginia Commonwealth University
Study design
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
--participants must be: * healthy (determined by self-report) * between the ages of 18-55 * willing to provide informed consent * able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol * cigarette smokers
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Nicotine | 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. | Change in plasma nicotine level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | 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. |
| Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | 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. |
| Hughes-Hatsukami Questionnaire - Anxious | 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. |
| Hughes-Hatsukami Questionnaire - Craving | 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. |
| Hughes-Hatsukami Questionnaire - Depression | 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. |
| Hughes-Hatsukami Questionnaire - Difficulty Concentrating | 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. |
| Hughes-Hatsukami Questionnaire - Drowsy | 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. |
| Hughes-Hatsukami Questionnaire - Hunger | 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. |
| Hughes-Hatsukami Questionnaire - Impatient | 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. |
| Hughes-Hatsukami Questionnaire - Irritable | 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. |
| Hughes-Hatsukami Questionnaire - Restless | 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. |
| Hughes-Hatsukami Questionnaire - Desire for Sweets | 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. |
| Hughes-Hatsukami Questionnaire - Urge to Smoke | 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. |
| Direct Effects of Nicotine Questionnaire - Awake | 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). |
| Direct Effects of Nicotine Questionnaire - Calm | 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). |
| Direct Effects of Nicotine Questionnaire - Concentrate | 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). |
| Direct Effects of Nicotine Questionnaire - Dizzy | 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). |
| Direct Effects of Nicotine Questionnaire - Reduce Hunger | 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). |
| Direct Effects of Nicotine Questionnaire - Sick | 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). |
| Direct Effects of Product Use Questionnaire - Pleasant | 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). |
| Direct Effects of Product Use Questionnaire - Taste Good | 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). |
| Direct Effects of Product Use Questionnaire - Satisfying | 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). |
| Direct Effects of Product Use Questionnaire - Smoke Right Now | 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). |
| Carbon Monoxide Levels | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Heat rate will be measured from baseline continuously throughout each each approximately 4-hr session | Change in heart rate, measured in beats per minute |
| Blood Pressure | Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session | Change in blood pressure, measured in mm/hg |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Electronic Cigarette vs Own Brand Use |
|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Population: One participant was missing a sample so data was only available for 17 participants for these analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Change in Plasma Nicotine | Post puff bout | 7.62 ng/ml | Standard Deviation 4.86 |
| JUUL Electronic Cigarette Use | Change in Plasma Nicotine | Post ad lib | 7.19 ng/ml | Standard Deviation 8.32 |
| IQOS Electronic Cigarette Use | Change in Plasma Nicotine | Post puff bout | 10.65 ng/ml | Standard Deviation 6.2 |
| IQOS Electronic Cigarette Use | Change in Plasma Nicotine | Post ad lib | 5.97 ng/ml | Standard Deviation 7.7 |
| Own Brand Cigarette Use | Change in Plasma Nicotine | Post puff bout | 18.31 ng/ml | Standard Deviation 11.39 |
| Own Brand Cigarette Use | Change in Plasma Nicotine | Post ad lib | 12.23 ng/ml | Standard Deviation 9.26 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Carbon Monoxide Levels | Pre puff bout | 5.2 Parts per mission | Standard Deviation 2.4 |
| JUUL Electronic Cigarette Use | Carbon Monoxide Levels | Post puff bout | 8.7 Parts per mission | Standard Deviation 2.5 |
| JUUL Electronic Cigarette Use | Carbon Monoxide Levels | Pre ad lib | 8.8 Parts per mission | Standard Deviation 2.8 |
| JUUL Electronic Cigarette Use | Carbon Monoxide Levels | Post ad lib | 16.6 Parts per mission | Standard Deviation 7 |
| IQOS Electronic Cigarette Use | Carbon Monoxide Levels | Post ad lib | 4.7 Parts per mission | Standard Deviation 1.9 |
| IQOS Electronic Cigarette Use | Carbon Monoxide Levels | Pre puff bout | 5.5 Parts per mission | Standard Deviation 2.4 |
| IQOS Electronic Cigarette Use | Carbon Monoxide Levels | Pre ad lib | 5.3 Parts per mission | Standard Deviation 2.4 |
| IQOS Electronic Cigarette Use | Carbon Monoxide Levels | Post puff bout | 5.1 Parts per mission | Standard Deviation 2.3 |
| Own Brand Cigarette Use | Carbon Monoxide Levels | Post ad lib | 4.3 Parts per mission | Standard Deviation 1.4 |
| Own Brand Cigarette Use | Carbon Monoxide Levels | Post puff bout | 4.9 Parts per mission | Standard Deviation 1.8 |
| Own Brand Cigarette Use | Carbon Monoxide Levels | Pre ad lib | 4.6 Parts per mission | Standard Deviation 1.8 |
| Own Brand Cigarette Use | Carbon Monoxide Levels | Pre puff bout | 5.3 Parts per mission | Standard Deviation 2 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Awake | Post puff bout | 40.9 score on a question | Standard Deviation 31.7 |
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Awake | Post ad lib | 45.1 score on a question | Standard Deviation 31.3 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Awake | Post puff bout | 33.8 score on a question | Standard Deviation 29.9 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Awake | Post ad lib | 28.1 score on a question | Standard Deviation 29.6 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Awake | Post puff bout | 36.5 score on a question | Standard Deviation 30.6 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Awake | Post ad lib | 34.5 score on a question | Standard Deviation 27.4 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Calm | Post puff bout | 60.9 score on a question | Standard Deviation 36 |
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Calm | Post ad lib | 60.7 score on a question | Standard Deviation 35.3 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Calm | Post puff bout | 47.9 score on a question | Standard Deviation 31.9 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Calm | Post ad lib | 46.6 score on a question | Standard Deviation 29.7 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Calm | Post puff bout | 54.4 score on a question | Standard Deviation 31.5 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Calm | Post ad lib | 43.2 score on a question | Standard Deviation 34.5 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Concentrate | Post puff bout | 34.8 score on a question | Standard Deviation 30.8 |
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Concentrate | Post ad lib | 42.0 score on a question | Standard Deviation 34.3 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Concentrate | Post puff bout | 24.5 score on a question | Standard Deviation 26.3 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Concentrate | Post ad lib | 27.5 score on a question | Standard Deviation 26.3 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Concentrate | Post puff bout | 38.5 score on a question | Standard Deviation 33.7 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Concentrate | Post ad lib | 27.8 score on a question | Standard Deviation 27.1 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Dizzy | Post puff bout | 40.7 score on a question | Standard Deviation 33.4 |
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Dizzy | Post ad lib | 30.1 score on a question | Standard Deviation 36.2 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Dizzy | Post puff bout | 33.7 score on a question | Standard Deviation 33.5 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Dizzy | Post ad lib | 19.4 score on a question | Standard Deviation 27.2 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Dizzy | Post puff bout | 36.4 score on a question | Standard Deviation 33.7 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Dizzy | Post ad lib | 26.9 score on a question | Standard Deviation 25.8 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Reduce Hunger | Post puff bout | 41.9 score on a question | Standard Deviation 29.9 |
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Reduce Hunger | Post ad lib | 33.0 score on a question | Standard Deviation 27.7 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Reduce Hunger | Post puff bout | 35.2 score on a question | Standard Deviation 27.4 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Reduce Hunger | Post ad lib | 37.1 score on a question | Standard Deviation 31 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Reduce Hunger | Post puff bout | 29.2 score on a question | Standard Deviation 28.8 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Reduce Hunger | Post ad lib | 34.3 score on a question | Standard Deviation 26.1 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Sick | Post puff bout | 4.1 score on a question | Standard Deviation 7.5 |
| JUUL Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Sick | Post ad lib | 2.6 score on a question | Standard Deviation 5.2 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Sick | Post puff bout | 8.1 score on a question | Standard Deviation 14.2 |
| IQOS Electronic Cigarette Use | Direct Effects of Nicotine Questionnaire - Sick | Post ad lib | 7.8 score on a question | Standard Deviation 14.4 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Sick | Post puff bout | 9.5 score on a question | Standard Deviation 19 |
| Own Brand Cigarette Use | Direct Effects of Nicotine Questionnaire - Sick | Post ad lib | 10.5 score on a question | Standard Deviation 16.8 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Pleasant | Post puff bout | 81.4 score on a question | Standard Deviation 29.8 |
| JUUL Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Pleasant | Post ad lib | 81.9 score on a question | Standard Deviation 24.9 |
| IQOS Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Pleasant | Post puff bout | 50.4 score on a question | Standard Deviation 31.6 |
| IQOS Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Pleasant | Post ad lib | 50.6 score on a question | Standard Deviation 31.2 |
| Own Brand Cigarette Use | Direct Effects of Product Use Questionnaire - Pleasant | Post puff bout | 58.8 score on a question | Standard Deviation 36 |
| Own Brand Cigarette Use | Direct Effects of Product Use Questionnaire - Pleasant | Post ad lib | 58.9 score on a question | Standard Deviation 34.4 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Satisfying | Post puff bout | 84.3 score on a question | Standard Deviation 24.4 |
| JUUL Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Satisfying | Post ad lib | 83.7 score on a question | Standard Deviation 24.5 |
| IQOS Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Satisfying | Post puff bout | 47.0 score on a question | Standard Deviation 33.2 |
| IQOS Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Satisfying | Post ad lib | 46.5 score on a question | Standard Deviation 31.5 |
| Own Brand Cigarette Use | Direct Effects of Product Use Questionnaire - Satisfying | Post puff bout | 58.8 score on a question | Standard Deviation 30.9 |
| Own Brand Cigarette Use | Direct Effects of Product Use Questionnaire - Satisfying | Post ad lib | 58.8 score on a question | Standard Deviation 33.3 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Smoke Right Now | Post puff bout | 62.8 score on a question | Standard Deviation 37.7 |
| JUUL Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Smoke Right Now | Post ad lib | 44.1 score on a question | Standard Deviation 37.7 |
| IQOS Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Smoke Right Now | Post puff bout | 45.4 score on a question | Standard Deviation 32.7 |
| IQOS Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Smoke Right Now | Post ad lib | 35.5 score on a question | Standard Deviation 29.1 |
| Own Brand Cigarette Use | Direct Effects of Product Use Questionnaire - Smoke Right Now | Post puff bout | 47.2 score on a question | Standard Deviation 39.1 |
| Own Brand Cigarette Use | Direct Effects of Product Use Questionnaire - Smoke Right Now | Post ad lib | 37.5 score on a question | Standard Deviation 33.5 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Taste Good | Post puff bout | 77.7 score on a question | Standard Deviation 29.5 |
| JUUL Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Taste Good | Post ad lib | 74.0 score on a question | Standard Deviation 32.1 |
| IQOS Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Taste Good | Post puff bout | 50.5 score on a question | Standard Deviation 32.6 |
| IQOS Electronic Cigarette Use | Direct Effects of Product Use Questionnaire - Taste Good | Post ad lib | 51.2 score on a question | Standard Deviation 30.7 |
| Own Brand Cigarette Use | Direct Effects of Product Use Questionnaire - Taste Good | Post puff bout | 54.6 score on a question | Standard Deviation 36.4 |
| Own Brand Cigarette Use | Direct Effects of Product Use Questionnaire - Taste Good | Post ad lib | 49.8 score on a question | Standard Deviation 35.7 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Pre puff bout | 46.3 score on a scale | Standard Deviation 32.5 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Post puff bout | 24.8 score on a scale | Standard Deviation 30.6 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Pre ad lib | 22.1 score on a scale | Standard Deviation 22.8 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Post ad lib | 19.4 score on a scale | Standard Deviation 27.5 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Post ad lib | 20.4 score on a scale | Standard Deviation 27 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Pre puff bout | 42.8 score on a scale | Standard Deviation 31.9 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Pre ad lib | 20.8 score on a scale | Standard Deviation 30.1 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Post puff bout | 24.4 score on a scale | Standard Deviation 31.8 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Post ad lib | 28.4 score on a scale | Standard Deviation 32.6 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Post puff bout | 28.4 score on a scale | Standard Deviation 33.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Pre ad lib | 17.2 score on a scale | Standard Deviation 27.2 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Anxious | Pre puff bout | 44.5 score on a scale | Standard Deviation 34.9 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Pre puff bout | 75.2 points on a scale | Standard Deviation 30.7 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Post puff bout | 34.9 points on a scale | Standard Deviation 35 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Pre ad lib | 55.2 points on a scale | Standard Deviation 30.5 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Post ad lib | 25.5 points on a scale | Standard Deviation 29.2 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Post ad lib | 53.9 points on a scale | Standard Deviation 34.9 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Pre puff bout | 70.5 points on a scale | Standard Deviation 30.9 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Pre ad lib | 54.0 points on a scale | Standard Deviation 38 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Post puff bout | 49.3 points on a scale | Standard Deviation 36 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Post ad lib | 36.2 points on a scale | Standard Deviation 32.1 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Post puff bout | 42.9 points on a scale | Standard Deviation 31.8 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Pre ad lib | 53.8 points on a scale | Standard Deviation 29.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Craving | Pre puff bout | 73.5 points on a scale | Standard Deviation 33.5 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Pre puff bout | 21.4 points on a scale | Standard Deviation 28.3 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Post puff bout | 9.8 points on a scale | Standard Deviation 16.8 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Pre ad lib | 11.5 points on a scale | Standard Deviation 21.5 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Post ad lib | 8.8 points on a scale | Standard Deviation 13.6 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Post ad lib | 8.2 points on a scale | Standard Deviation 16.3 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Pre puff bout | 15.1 points on a scale | Standard Deviation 20.9 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Pre ad lib | 8.1 points on a scale | Standard Deviation 17 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Post puff bout | 8.8 points on a scale | Standard Deviation 16.6 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Post ad lib | 11.5 points on a scale | Standard Deviation 21.7 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Post puff bout | 15.1 points on a scale | Standard Deviation 22.6 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Pre ad lib | 10.6 points on a scale | Standard Deviation 20.1 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Depression | Pre puff bout | 20.5 points on a scale | Standard Deviation 26.1 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Pre puff bout | 24.2 points on a scale | Standard Deviation 30.7 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Post puff bout | 16.8 points on a scale | Standard Deviation 21.4 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Pre ad lib | 18.8 points on a scale | Standard Deviation 25.8 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Post ad lib | 17.9 points on a scale | Standard Deviation 21.3 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Post ad lib | 17.4 points on a scale | Standard Deviation 24 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Pre puff bout | 27.4 points on a scale | Standard Deviation 33.3 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Pre ad lib | 20.7 points on a scale | Standard Deviation 28.1 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Post puff bout | 20.3 points on a scale | Standard Deviation 27.2 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Post ad lib | 20.5 points on a scale | Standard Deviation 27 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Post puff bout | 16.4 points on a scale | Standard Deviation 25.7 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Pre ad lib | 23.8 points on a scale | Standard Deviation 27.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Desire for Sweets | Pre puff bout | 24.8 points on a scale | Standard Deviation 28.3 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Pre puff bout | 28.2 points on a scale | Standard Deviation 26.4 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Post puff bout | 18.5 points on a scale | Standard Deviation 20.4 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Pre ad lib | 18.1 points on a scale | Standard Deviation 20.8 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Post ad lib | 10.4 points on a scale | Standard Deviation 18.1 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Post ad lib | 17.8 points on a scale | Standard Deviation 25.8 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Pre puff bout | 37.6 points on a scale | Standard Deviation 30.1 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Pre ad lib | 15.5 points on a scale | Standard Deviation 22.5 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Post puff bout | 17.3 points on a scale | Standard Deviation 19.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Post ad lib | 18.9 points on a scale | Standard Deviation 27 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Post puff bout | 24.4 points on a scale | Standard Deviation 29.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Pre ad lib | 16.8 points on a scale | Standard Deviation 20.6 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Difficulty Concentrating | Pre puff bout | 30.0 points on a scale | Standard Deviation 31.9 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Pre puff bout | 35.2 points on a scale | Standard Deviation 25 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Post puff bout | 28.7 points on a scale | Standard Deviation 26.1 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Pre ad lib | 24.9 points on a scale | Standard Deviation 24.3 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Post ad lib | 23.4 points on a scale | Standard Deviation 26.9 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Post ad lib | 25.3 points on a scale | Standard Deviation 27 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Pre puff bout | 33.8 points on a scale | Standard Deviation 28.2 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Pre ad lib | 25.9 points on a scale | Standard Deviation 31.1 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Post puff bout | 21.4 points on a scale | Standard Deviation 24.6 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Post ad lib | 27.4 points on a scale | Standard Deviation 29.8 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Post puff bout | 29.4 points on a scale | Standard Deviation 26.5 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Pre ad lib | 23.4 points on a scale | Standard Deviation 24.6 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Drowsy | Pre puff bout | 31.9 points on a scale | Standard Deviation 33.9 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Pre puff bout | 39.9 points on a scale | Standard Deviation 22.7 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Post puff bout | 31.9 points on a scale | Standard Deviation 24.4 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Pre ad lib | 34.8 points on a scale | Standard Deviation 25.9 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Post ad lib | 39.8 points on a scale | Standard Deviation 30.7 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Post ad lib | 58.4 points on a scale | Standard Deviation 29 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Pre puff bout | 43.2 points on a scale | Standard Deviation 29.8 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Pre ad lib | 39.5 points on a scale | Standard Deviation 35.9 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Post puff bout | 35.6 points on a scale | Standard Deviation 33.3 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Post ad lib | 53.2 points on a scale | Standard Deviation 31.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Post puff bout | 30.2 points on a scale | Standard Deviation 25.5 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Pre ad lib | 37.7 points on a scale | Standard Deviation 29 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Hunger | Pre puff bout | 43.0 points on a scale | Standard Deviation 35.5 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Post ad lib | 25.5 points on a scale | Standard Deviation 28.2 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Pre ad lib | 26.9 points on a scale | Standard Deviation 29.3 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Post puff bout | 23.9 points on a scale | Standard Deviation 27.3 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Pre puff bout | 42.1 points on a scale | Standard Deviation 28.3 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Post puff bout | 25.9 points on a scale | Standard Deviation 31 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Post ad lib | 31.8 points on a scale | Standard Deviation 30.5 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Pre puff bout | 41.0 points on a scale | Standard Deviation 30.6 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Pre ad lib | 31.4 points on a scale | Standard Deviation 28.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Post ad lib | 27.2 points on a scale | Standard Deviation 27 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Pre puff bout | 51.4 points on a scale | Standard Deviation 31 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Post puff bout | 25.1 points on a scale | Standard Deviation 30.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Impatient | Pre ad lib | 29.7 points on a scale | Standard Deviation 30.3 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Pre puff bout | 37.4 points on a scale | Standard Deviation 31 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Post puff bout | 14.9 points on a scale | Standard Deviation 17.2 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Pre ad lib | 14.1 points on a scale | Standard Deviation 16 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Post ad lib | 14.6 points on a scale | Standard Deviation 22 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Post ad lib | 15.1 points on a scale | Standard Deviation 26.4 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Pre puff bout | 34.5 points on a scale | Standard Deviation 31.1 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Pre ad lib | 15.4 points on a scale | Standard Deviation 22.3 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Post puff bout | 18.4 points on a scale | Standard Deviation 22.1 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Post ad lib | 16.8 points on a scale | Standard Deviation 24.1 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Post puff bout | 19.8 points on a scale | Standard Deviation 26.3 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Pre ad lib | 16.8 points on a scale | Standard Deviation 21 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Irritable | Pre puff bout | 38.7 points on a scale | Standard Deviation 33.3 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Pre puff bout | 40.8 points on a scale | Standard Deviation 29.4 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Post puff bout | 19.7 points on a scale | Standard Deviation 24.8 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Pre ad lib | 27.7 points on a scale | Standard Deviation 27.2 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Post ad lib | 21.5 points on a scale | Standard Deviation 28.1 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Post ad lib | 24.7 points on a scale | Standard Deviation 27.6 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Pre puff bout | 30.2 points on a scale | Standard Deviation 25.5 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Pre ad lib | 17.9 points on a scale | Standard Deviation 25.7 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Post puff bout | 26.9 points on a scale | Standard Deviation 25.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Post ad lib | 27.1 points on a scale | Standard Deviation 28.4 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Post puff bout | 19.7 points on a scale | Standard Deviation 24.6 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Pre ad lib | 33.4 points on a scale | Standard Deviation 31.4 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Restless | Pre puff bout | 28.9 points on a scale | Standard Deviation 31.8 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Pre puff bout | 76.5 points on a scale | Standard Deviation 25.2 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Post puff bout | 39.2 points on a scale | Standard Deviation 34.8 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Pre ad lib | 54.4 points on a scale | Standard Deviation 27.6 |
| JUUL Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Post ad lib | 24.9 points on a scale | Standard Deviation 25.7 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Post ad lib | 50.0 points on a scale | Standard Deviation 31.1 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Pre puff bout | 67.2 points on a scale | Standard Deviation 29.9 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Pre ad lib | 46.9 points on a scale | Standard Deviation 33.3 |
| IQOS Electronic Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Post puff bout | 48.8 points on a scale | Standard Deviation 31.9 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Post ad lib | 38 points on a scale | Standard Deviation 31.8 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Post puff bout | 46.2 points on a scale | Standard Deviation 29.5 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Pre ad lib | 56.9 points on a scale | Standard Deviation 27.8 |
| Own Brand Cigarette Use | Hughes-Hatsukami Questionnaire - Urge to Smoke | Pre puff bout | 74.7 points on a scale | Standard Deviation 31.5 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Pre puff bout | 24.8 score on a scale | Standard Deviation 8.2 |
| JUUL Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Post puff bout | 13.2 score on a scale | Standard Deviation 10.7 |
| JUUL Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Pre ad lib | 21.2 score on a scale | Standard Deviation 8.9 |
| JUUL Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Post ad lib | 11.5 score on a scale | Standard Deviation 10.2 |
| IQOS Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Post ad lib | 17.8 score on a scale | Standard Deviation 10.6 |
| IQOS Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Pre puff bout | 24.7 score on a scale | Standard Deviation 7.5 |
| IQOS Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Pre ad lib | 21.7 score on a scale | Standard Deviation 9.3 |
| IQOS Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Post puff bout | 20.1 score on a scale | Standard Deviation 9.3 |
| Own Brand Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Post ad lib | 14.4 score on a scale | Standard Deviation 9.7 |
| Own Brand Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Post puff bout | 16.0 score on a scale | Standard Deviation 9.3 |
| Own Brand Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Pre ad lib | 20.4 score on a scale | Standard Deviation 8.5 |
| Own Brand Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 | Pre puff bout | 25.1 score on a scale | Standard Deviation 8.2 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUUL Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Pre puff bout | 11.7 score on a scale | Standard Deviation 8.3 |
| JUUL Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Post puff bout | 6.9 score on a scale | Standard Deviation 7.4 |
| JUUL Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Pre ad lib | 9.7 score on a scale | Standard Deviation 7.4 |
| JUUL Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Post ad lib | 5.5 score on a scale | Standard Deviation 7.6 |
| IQOS Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Post ad lib | 6.5 score on a scale | Standard Deviation 7.2 |
| IQOS Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Pre puff bout | 10.3 score on a scale | Standard Deviation 8.3 |
| IQOS Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Pre ad lib | 9.5 score on a scale | Standard Deviation 7.5 |
| IQOS Electronic Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Post puff bout | 8.1 score on a scale | Standard Deviation 7.8 |
| Own Brand Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Post ad lib | 6.6 score on a scale | Standard Deviation 8.9 |
| Own Brand Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Post puff bout | 6.6 score on a scale | Standard Deviation 7.8 |
| Own Brand Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Pre ad lib | 9.1 score on a scale | Standard Deviation 8.6 |
| Own Brand Cigarette Use | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 | Pre puff bout | 12.5 score on a scale | Standard Deviation 8.4 |
Other Pre-specified
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
Other Pre-specified
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