Trial Outcomes & Findings for Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers (NCT NCT03830892)
NCT ID: NCT03830892
Last Updated: 2021-06-04
Results Overview
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Up to 180 minutes
Results posted on
2021-06-04
Participant Flow
Each participant will participate in 6 sessions. Sessions differ by the tobacco product used (see study arms). The sessions are ordered by latin-square; however, session order was NOT expected to change any outcomes and order effects are not relevant to the study. Therefore all outcome data was merged and analyzed only by arm and session without regard to order.
Participant milestones
| Measure |
E-cigarette User (Exclusive)
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
|
Dual User
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
|
Overall Study
15 Watts, 10 mg Nicotine
|
19
|
17
|
|
Overall Study
15 Watts, 30 mg Nicotine
|
19
|
17
|
|
Overall Study
30 Watts, 10 mg Nicotine
|
19
|
17
|
|
Overall Study
30 Watts, 30 mg Nicotine
|
19
|
17
|
|
Overall Study
Own Brand
|
19
|
17
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
E-cigarette User (Exclusive)
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
|
Dual User
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Study terminated due to COVID
|
4
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers
Baseline characteristics by cohort
| Measure |
E-cigarette User (Exclusive)
n=19 Participants
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
|
Dual User
n=13 Participants
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.53 years
STANDARD_DEVIATION 7.53 • n=99 Participants
|
29 years
STANDARD_DEVIATION 6.84 • n=107 Participants
|
28.13 years
STANDARD_DEVIATION 7.18 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
13 participants
n=107 Participants
|
32 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 180 minutesPopulation: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Outcome measures
| Measure |
E-cigarette User (Exclusive)
n=19 Participants
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
|
Dual User
n=13 Participants
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
|
|---|---|---|
|
Breakpoint of Drug Purchase Tasks (DPT)
own brand e-cigarette
|
3.95 US Dollars
Standard Deviation 3.59
|
3.79 US Dollars
Standard Deviation 3.09
|
|
Breakpoint of Drug Purchase Tasks (DPT)
30 watts, 30 mg/ml nicotine
|
3.29 US Dollars
Standard Deviation 3.73
|
4.43 US Dollars
Standard Deviation 3.74
|
|
Breakpoint of Drug Purchase Tasks (DPT)
15 watts, 30 mg/ml nicotine
|
3.51 US Dollars
Standard Deviation 3.41
|
4.26 US Dollars
Standard Deviation 3.63
|
|
Breakpoint of Drug Purchase Tasks (DPT)
30 watts, 10 mg/ml nicotine
|
3.37 US Dollars
Standard Deviation 3.43
|
4.23 US Dollars
Standard Deviation 3.77
|
|
Breakpoint of Drug Purchase Tasks (DPT)
15 watts, 10 mg/ml nicotine
|
3.74 US Dollars
Standard Deviation 3.50
|
4.80 US Dollars
Standard Deviation 3.86
|
PRIMARY outcome
Timeframe: Up to 180 minutes.Population: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.
The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Outcome measures
| Measure |
E-cigarette User (Exclusive)
n=19 Participants
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
|
Dual User
n=13 Participants
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
|
|---|---|---|
|
Breakpoint of Multiple Choice Procedure (MCP)
Own brand e-cigarette
|
3.05 US Dollars
Standard Deviation 2.92
|
2.90 US Dollars
Standard Deviation 2.99
|
|
Breakpoint of Multiple Choice Procedure (MCP)
30 watts, 30 mg/ml nicotine
|
2.51 US Dollars
Standard Deviation 3.18
|
2.36 US Dollars
Standard Deviation 2.41
|
|
Breakpoint of Multiple Choice Procedure (MCP)
15 watts, 30 mg/ml nicotine
|
2.56 US Dollars
Standard Deviation 2.93
|
2.51 US Dollars
Standard Deviation 1.98
|
|
Breakpoint of Multiple Choice Procedure (MCP)
30 watts, 10 mg/ml nicotine
|
2.63 US Dollars
Standard Deviation 2.98
|
2.10 US Dollars
Standard Deviation 2.06
|
|
Breakpoint of Multiple Choice Procedure (MCP)
15 watts, 10 mg/ml nicotine
|
2.35 US Dollars
Standard Deviation 2.13
|
2.23 US Dollars
Standard Deviation 2.34
|
PRIMARY outcome
Timeframe: Up to 180 minutes.Population: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.
The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Outcome measures
| Measure |
E-cigarette User (Exclusive)
n=19 Participants
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
|
Dual User
n=13 Participants
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
|
|---|---|---|
|
Effort for Product Puffs With the Progressive Ratio Task (PRT)
own brand e-cigarette
|
4.95 e-cigarette puffs
Standard Deviation 1.54
|
4.54 e-cigarette puffs
Standard Deviation 1.56
|
|
Effort for Product Puffs With the Progressive Ratio Task (PRT)
30 watts, 30 mg/ml nicotine
|
4.74 e-cigarette puffs
Standard Deviation 1.88
|
4.54 e-cigarette puffs
Standard Deviation 1.76
|
|
Effort for Product Puffs With the Progressive Ratio Task (PRT)
15 watts, 30 mg/ml nicotine
|
4.58 e-cigarette puffs
Standard Deviation 1.77
|
4.38 e-cigarette puffs
Standard Deviation 2.06
|
|
Effort for Product Puffs With the Progressive Ratio Task (PRT)
30 watts, 10 mg/ml nicotine
|
5.58 e-cigarette puffs
Standard Deviation 1.68
|
5.38 e-cigarette puffs
Standard Deviation 1.56
|
|
Effort for Product Puffs With the Progressive Ratio Task (PRT)
15 watts, 10 mg/ml nicotine
|
4.89 e-cigarette puffs
Standard Deviation 1.59
|
4.77 e-cigarette puffs
Standard Deviation 1.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First measure given, regardless of task order, 90 minutes into each sessionMeasures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Recorded throughout each 4 hour study session using automated software every 10 seconds.Heart rate (measured in bpm)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Recorded throughout each 4 hour study session using automated software every 5 minutes.Blood pressure (measured in mm)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Recorded throughout each 4 hour study session using automated software every 5 minutes.and blood pressure (measured in hg)
Outcome measures
Outcome data not reported
Adverse Events
E-cigarette User (Exclusive)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dual User
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E-cigarette User (Exclusive)
n=19 participants at risk
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
|
Dual User
n=13 participants at risk
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization
|
5.3%
1/19 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
0.00%
0/13 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
Other adverse events
| Measure |
E-cigarette User (Exclusive)
n=19 participants at risk
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
|
Dual User
n=13 participants at risk
Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Worsening cough
|
5.3%
1/19 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
7.7%
1/13 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
5.3%
1/19 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
7.7%
1/13 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
7.7%
1/13 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
7.7%
1/13 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
7.7%
1/13 • Number of events 1 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/19 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
15.4%
2/13 • Number of events 2 • Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place