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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electronic cigarette vs own brand use | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUUL electronic cigarette | Other | Effects of JUUL electronic cigarette use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma Nicotine | Change in plasma nicotine level | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Carbon Monoxide Levels | Carbon monoxide levels (in parts per mission) | 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. |
| Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Change in heart rate, measured in beats per minute | Heat rate will be measured from baseline continuously throughout each each approximately 4-hr session |
| Blood Pressure | Change in blood pressure, measured in mm/hg |
Inclusion Criteria--participants must be:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Alison Breland, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Behavioral Pharmacolgy Laboratory | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Plasma Nicotine | Change in plasma nicotine level | One participant was missing a sample so data was only available for 17 participants for these analyses. | Posted | Mean | Standard Deviation | ng/ml | 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. |
|
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This protocol was minimal risk and All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JUUL Electronic Cigarette Use | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Breland | Virginia Commonwealth University | 804 628 2300 | abbrelan@vcu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2019 | Aug 16, 2019 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 11, 2019 | Jun 25, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| IQOS electronic cigarette | Other | Effects of IQOS electronic cigarette use. |
|
| Own Brand cigarette | Other | Effects of own brand cigarette use. |
|
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. |
| 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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. |
| OG002 | Own Brand Cigarette Use | 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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| Secondary | Carbon Monoxide Levels | Carbon monoxide levels (in parts per mission) | Posted | Mean | Standard Deviation | Parts per mission | 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. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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. | Posted | Mean | Standard Deviation | points on a scale | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| 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). | Posted | Mean | Standard Deviation | score on a question | 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. |
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| Other Pre-specified | Heart Rate | Change in heart rate, measured in beats per minute | Not Posted | Heat rate will be measured from baseline continuously throughout each each approximately 4-hr session | Participants |
| Other Pre-specified | Blood Pressure | Change in blood pressure, measured in mm/hg | Not Posted | Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | IQOS Electronic Cigarette Use | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Own Brand Cigarette Use | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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