Assessment of Two New Electronic Cigarettes in Cigarette Smokers
Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT03435562
Collaborator
(none)
22
1
1
17.4
1.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
22 participants
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of Two New Electronic Cigarettes in Cigarette Smokers
Actual Study Start Date
:
Mar 3, 2018
Actual Primary Completion Date
:
Aug 16, 2019
Actual Study Completion Date
:
Aug 16, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: electronic cigarette vs own brand use Participants will come in for three session. During one session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (the session will be approximately 3 hours). The order of the sessions will be determined randomly and data about session will not be recorded or used in the analysis. |
Other: JUUL electronic cigarette
Effects of JUUL electronic cigarette use.
Other: IQOS electronic cigarette
Effects of IQOS electronic cigarette use.
Other: Own Brand cigarette
Effects of own brand cigarette use.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- 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).
Other Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Behavioral Pharmacolgy Laboratory | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Alison Breland, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT03435562
Other Study ID Numbers:
- HM20012013
First Posted:
Feb 19, 2018
Last Update Posted:
Aug 3, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Electronic Cigarette vs Own Brand Use |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 22 |
| COMPLETED | 18 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Electronic Cigarette vs Own Brand Use |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 18 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
36.8
(9.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
5
27.8%
|
| Male |
13
72.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
5.6%
|
| Not Hispanic or Latino |
15
83.3%
|
| Unknown or Not Reported |
2
11.1%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
7
38.9%
|
| White |
8
44.4%
|
| More than one race |
2
11.1%
|
| Unknown or Not Reported |
1
5.6%
|
Outcome Measures
| Title | Change in Plasma Nicotine |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant was missing a sample so data was only available for 17 participants for these analyses. |
| Arm/Group Title | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use | Own Brand Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 17 | 17 | 17 |
| Post puff bout |
7.62
(4.86)
|
10.65
(6.20)
|
18.31
(11.39)
|
| Post ad lib |
7.19
(8.32)
|
5.97
(7.70)
|
12.23
(9.26)
|
| Title | Carbon Monoxide Levels |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
5.2
(2.4)
|
5.5
(2.4)
|
5.3
(2.0)
|
| Post puff bout |
8.7
(2.5)
|
5.1
(2.3)
|
4.9
(1.8)
|
| Pre ad lib |
8.8
(2.8)
|
5.3
(2.4)
|
4.6
(1.8)
|
| Post ad lib |
16.6
(7.0)
|
4.7
(1.9)
|
4.3
(1.4)
|
| Title | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1 |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
24.8
(8.2)
|
24.7
(7.5)
|
25.1
(8.2)
|
| Post puff bout |
13.2
(10.7)
|
20.1
(9.3)
|
16.0
(9.3)
|
| Pre ad lib |
21.2
(8.9)
|
21.7
(9.3)
|
20.4
(8.5)
|
| Post ad lib |
11.5
(10.2)
|
17.8
(10.6)
|
14.4
(9.7)
|
| Title | Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2 |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
11.7
(8.3)
|
10.3
(8.3)
|
12.5
(8.4)
|
| Post puff bout |
6.9
(7.4)
|
8.1
(7.8)
|
6.6
(7.8)
|
| Pre ad lib |
9.7
(7.4)
|
9.5
(7.5)
|
9.1
(8.6)
|
| Post ad lib |
5.5
(7.6)
|
6.5
(7.2)
|
6.6
(8.9)
|
| Title | Hughes-Hatsukami Questionnaire - Anxious |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
46.3
(32.5)
|
42.8
(31.9)
|
44.5
(34.9)
|
| Post puff bout |
24.8
(30.6)
|
24.4
(31.8)
|
28.4
(33.9)
|
| Pre ad lib |
22.1
(22.8)
|
20.8
(30.1)
|
17.2
(27.2)
|
| Post ad lib |
19.4
(27.5)
|
20.4
(27)
|
28.4
(32.6)
|
| Title | Hughes-Hatsukami Questionnaire - Craving |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
75.2
(30.7)
|
70.5
(30.9)
|
73.5
(33.5)
|
| Post puff bout |
34.9
(35)
|
49.3
(36.0)
|
42.9
(31.8)
|
| Pre ad lib |
55.2
(30.5)
|
54.0
(38)
|
53.8
(29.9)
|
| Post ad lib |
25.5
(29.2)
|
53.9
(34.9)
|
36.2
(32.1)
|
| Title | Hughes-Hatsukami Questionnaire - Depression |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
21.4
(28.3)
|
15.1
(20.9)
|
20.5
(26.1)
|
| Post puff bout |
9.8
(16.8)
|
8.8
(16.6)
|
15.1
(22.6)
|
| Pre ad lib |
11.5
(21.5)
|
8.1
(17.0)
|
10.6
(20.1)
|
| Post ad lib |
8.8
(13.6)
|
8.2
(16.3)
|
11.5
(21.7)
|
| Title | Hughes-Hatsukami Questionnaire - Difficulty Concentrating |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
28.2
(26.4)
|
37.6
(30.1)
|
30.0
(31.9)
|
| Post puff bout |
18.5
(20.4)
|
17.3
(19.9)
|
24.4
(29.9)
|
| Pre ad lib |
18.1
(20.8)
|
15.5
(22.5)
|
16.8
(20.6)
|
| Post ad lib |
10.4
(18.1)
|
17.8
(25.8)
|
18.9
(27.0)
|
| Title | Hughes-Hatsukami Questionnaire - Drowsy |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
35.2
(25)
|
33.8
(28.2)
|
31.9
(33.9)
|
| Post puff bout |
28.7
(26.1)
|
21.4
(24.6)
|
29.4
(26.5)
|
| Pre ad lib |
24.9
(24.3)
|
25.9
(31.1)
|
23.4
(24.6)
|
| Post ad lib |
23.4
(26.9)
|
25.3
(27.0)
|
27.4
(29.8)
|
| Title | Hughes-Hatsukami Questionnaire - Hunger |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
39.9
(22.7)
|
43.2
(29.8)
|
43.0
(35.5)
|
| Post puff bout |
31.9
(24.4)
|
35.6
(33.3)
|
30.2
(25.5)
|
| Pre ad lib |
34.8
(25.9)
|
39.5
(35.9)
|
37.7
(29.0)
|
| Post ad lib |
39.8
(30.7)
|
58.4
(29.0)
|
53.2
(31.9)
|
| Title | Hughes-Hatsukami Questionnaire - Impatient |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
42.1
(28.3)
|
41.0
(30.6)
|
51.4
(31.0)
|
| Post puff bout |
23.9
(27.3)
|
25.9
(31.0)
|
25.1
(30.9)
|
| Pre ad lib |
26.9
(29.3)
|
31.4
(28.9)
|
29.7
(30.3)
|
| Post ad lib |
25.5
(28.2)
|
31.8
(30.5)
|
27.2
(27.0)
|
| Title | Hughes-Hatsukami Questionnaire - Irritable |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
37.4
(31.0)
|
34.5
(31.1)
|
38.7
(33.3)
|
| Post puff bout |
14.9
(17.2)
|
18.4
(22.1)
|
19.8
(26.3)
|
| Pre ad lib |
14.1
(16.0)
|
15.4
(22.3)
|
16.8
(21.0)
|
| Post ad lib |
14.6
(22.0)
|
15.1
(26.4)
|
16.8
(24.1)
|
| Title | Hughes-Hatsukami Questionnaire - Restless |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
40.8
(29.4)
|
30.2
(25.5)
|
28.9
(31.8)
|
| Post puff bout |
19.7
(24.8)
|
26.9
(25.9)
|
19.7
(24.6)
|
| Pre ad lib |
27.7
(27.2)
|
17.9
(25.7)
|
33.4
(31.4)
|
| Post ad lib |
21.5
(28.1)
|
24.7
(27.6)
|
27.1
(28.4)
|
| Title | Hughes-Hatsukami Questionnaire - Desire for Sweets |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
24.2
(30.7)
|
27.4
(33.3)
|
24.8
(28.3)
|
| Post puff bout |
16.8
(21.4)
|
20.3
(27.2)
|
16.4
(25.7)
|
| Pre ad lib |
18.8
(25.8)
|
20.7
(28.1)
|
23.8
(27.9)
|
| Post ad lib |
17.9
(21.3)
|
17.4
(24.0)
|
20.5
(27.0)
|
| Title | Hughes-Hatsukami Questionnaire - Urge to Smoke |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Pre puff bout |
76.5
(25.2)
|
67.2
(29.9)
|
74.7
(31.5)
|
| Post puff bout |
39.2
(34.8)
|
48.8
(31.9)
|
46.2
(29.5)
|
| Pre ad lib |
54.4
(27.6)
|
46.9
(33.3)
|
56.9
(27.8)
|
| Post ad lib |
24.9
(25.7)
|
50.0
(31.1)
|
38
(31.8)
|
| Title | Direct Effects of Nicotine Questionnaire - Awake |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
40.9
(31.7)
|
33.8
(29.9)
|
36.5
(30.6)
|
| Post ad lib |
45.1
(31.3)
|
28.1
(29.6)
|
34.5
(27.4)
|
| Title | Direct Effects of Nicotine Questionnaire - Calm |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
60.9
(36)
|
47.9
(31.9)
|
54.4
(31.5)
|
| Post ad lib |
60.7
(35.3)
|
46.6
(29.7)
|
43.2
(34.5)
|
| Title | Direct Effects of Nicotine Questionnaire - Concentrate |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
34.8
(30.8)
|
24.5
(26.3)
|
38.5
(33.7)
|
| Post ad lib |
42.0
(34.3)
|
27.5
(26.3)
|
27.8
(27.1)
|
| Title | Direct Effects of Nicotine Questionnaire - Dizzy |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
40.7
(33.4)
|
33.7
(33.5)
|
36.4
(33.7)
|
| Post ad lib |
30.1
(36.2)
|
19.4
(27.2)
|
26.9
(25.8)
|
| Title | Direct Effects of Nicotine Questionnaire - Reduce Hunger |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
41.9
(29.9)
|
35.2
(27.4)
|
29.2
(28.8)
|
| Post ad lib |
33.0
(27.7)
|
37.1
(31.0)
|
34.3
(26.1)
|
| Title | Direct Effects of Nicotine Questionnaire - Sick |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
4.1
(7.5)
|
8.1
(14.2)
|
9.5
(19.0)
|
| Post ad lib |
2.6
(5.2)
|
7.8
(14.4)
|
10.5
(16.8)
|
| Title | Direct Effects of Product Use Questionnaire - Pleasant |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
81.4
(29.8)
|
50.4
(31.6)
|
58.8
(36.0)
|
| Post ad lib |
81.9
(24.9)
|
50.6
(31.2)
|
58.9
(34.4)
|
| Title | Direct Effects of Product Use Questionnaire - Taste Good |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
77.7
(29.5)
|
50.5
(32.6)
|
54.6
(36.4)
|
| Post ad lib |
74.0
(32.1)
|
51.2
(30.7)
|
49.8
(35.7)
|
| Title | Direct Effects of Product Use Questionnaire - Satisfying |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
84.3
(24.4)
|
47.0
(33.2)
|
58.8
(30.9)
|
| Post ad lib |
83.7
(24.5)
|
46.5
(31.5)
|
58.8
(33.3)
|
| Title | Direct Effects of Product Use Questionnaire - Smoke Right Now |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Own Brand Cigarette Use | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 18 | 18 | 18 |
| Post puff bout |
62.8
(37.7)
|
45.4
(32.7)
|
47.2
(39.1)
|
| Post ad lib |
44.1
(37.7)
|
35.5
(29.1)
|
37.5
(33.5)
|
| Title | Heart Rate |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Blood Pressure |
|---|---|
| Description | Change in blood pressure, measured in mm/hg |
| Time Frame | Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | This protocol was minimal risk and All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed. | |||||
| Arm/Group Title | JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use | Own Brand Cigarette Use | |||
| Arm/Group Description | 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. | 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. | 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. | |||
All Cause Mortality |
||||||
| JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use | Own Brand Cigarette Use | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Serious Adverse Events |
||||||
| JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use | Own Brand Cigarette Use | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
| JUUL Electronic Cigarette Use | IQOS Electronic Cigarette Use | Own Brand Cigarette Use | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alison Breland |
|---|---|
| Organization | Virginia Commonwealth University |
| Phone | 804 628 2300 |
| abbrelan@vcu.edu |
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT03435562
Other Study ID Numbers:
- HM20012013
First Posted:
Feb 19, 2018
Last Update Posted:
Aug 3, 2020
Last Verified:
Jul 1, 2020