Trial Outcomes & Findings for Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users (NCT NCT03710590)
NCT ID: NCT03710590
Last Updated: 2022-10-06
Results Overview
Change in plasma nicotine level.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline to 5 min after the start of a 10-puff product use
Results posted on
2022-10-06
Participant Flow
Not-completed reason was not stored by treatment arm
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 |
Cigarette Smokers
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
E-cigarette Users
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
Session 1: ECIG Lab Session 15 Watts, 10 mg Nicotine
|
12
|
15
|
|
Overall Study
Session 2: ECIG Lab Session 15 Watts, 15 mg Nicotine
|
12
|
15
|
|
Overall Study
Session 3: ECIG Lab Session 15 Watts, 30 mg Nicotine
|
12
|
15
|
|
Overall Study
Session 4: ECIG Lab Session 30 Watts, 10 mg Nicotine
|
12
|
15
|
|
Overall Study
Session 5: ECIG Lab Session 30 Watts, 15 mg Nicotine
|
12
|
15
|
|
Overall Study
Session 6: ECIG Lab Session 30 Watts, 30 mg Nicotine
|
12
|
15
|
|
Overall Study
COMPLETED
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
Cigarette Smokers
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
E-cigarette Users
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
|---|---|---|
|
Overall Study
Lost to follow up, study stopped due to COVID-19, other reasons
|
10
|
8
|
Baseline Characteristics
Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users
Baseline characteristics by cohort
| Measure |
Cigarette Smokers
n=12 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
E-cigarette Users
n=15 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.67 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
25.40 years
STANDARD_DEVIATION 7.94 • n=7 Participants
|
29.07 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 min after the start of a 10-puff product useChange in plasma nicotine level.
Outcome measures
| Measure |
Cigarette Smokers
n=12 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
E-cigarette Users
n=15 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
|---|---|---|
|
Change in Plasma Nicotine
10mg 15 Watts
|
8.68 ng/ml
Standard Deviation 7.22
|
8.28 ng/ml
Standard Deviation 9.65
|
|
Change in Plasma Nicotine
10mg 30 Watts
|
9.53 ng/ml
Standard Deviation 7.53
|
12.00 ng/ml
Standard Deviation 10.29
|
|
Change in Plasma Nicotine
15mg 15 Watts
|
7.34 ng/ml
Standard Deviation 6.19
|
7.17 ng/ml
Standard Deviation 6.14
|
|
Change in Plasma Nicotine
15mg 30 Watts
|
13.04 ng/ml
Standard Deviation 13.14
|
14.04 ng/ml
Standard Deviation 12.08
|
|
Change in Plasma Nicotine
30mg 15 Watts
|
10.18 ng/ml
Standard Deviation 9.28
|
20.12 ng/ml
Standard Deviation 22.40
|
|
Change in Plasma Nicotine
30mg 30 Watts
|
17.28 ng/ml
Standard Deviation 18.05
|
22.38 ng/ml
Standard Deviation 21.04
|
PRIMARY outcome
Timeframe: Each time the e-cigarette is used during the 10-puff use bout - 5 minutesPopulation: One participant did not have data for this measure.
The average volume of each puff, in ml, during 10 puff bout.
Outcome measures
| Measure |
Cigarette Smokers
n=11 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
E-cigarette Users
n=15 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
|---|---|---|
|
Puff Volume
10 mg, 15 Watts
|
457.27 ml
Standard Deviation 223.02
|
748.34 ml
Standard Deviation 412.22
|
|
Puff Volume
10 mg, 30 Watts
|
245.11 ml
Standard Deviation 124.09
|
503.43 ml
Standard Deviation 216.28
|
|
Puff Volume
15 mg, 15 Watts
|
350.18 ml
Standard Deviation 190.97
|
708.62 ml
Standard Deviation 300.45
|
|
Puff Volume
15 mg, 30 Watts
|
217.01 ml
Standard Deviation 94.99
|
409.56 ml
Standard Deviation 208.61
|
|
Puff Volume
30 mg, 15 Watts
|
310.95 ml
Standard Deviation 199.06
|
631.23 ml
Standard Deviation 225.84
|
|
Puff Volume
30 mg, 30 Watts
|
176.32 ml
Standard Deviation 79.76
|
415.85 ml
Standard Deviation 186.33
|
PRIMARY outcome
Timeframe: Each time the e-cigarette is used during the 10-puff use bout - 5 minutesPopulation: One participant did not have data collected for this measure.
The average duration of each puff, in seconds.
Outcome measures
| Measure |
Cigarette Smokers
n=11 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
E-cigarette Users
n=15 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
|---|---|---|
|
Puff Duration
30 mg, 15 W
|
2.44 seconds
Standard Deviation 0.83
|
3.41 seconds
Standard Deviation 1.01
|
|
Puff Duration
30 mg, 30 W
|
1.58 seconds
Standard Deviation 0.45
|
2.45 seconds
Standard Deviation 0.84
|
|
Puff Duration
10 mg, 15 W
|
3.04 seconds
Standard Deviation 1.01
|
4.37 seconds
Standard Deviation 1.15
|
|
Puff Duration
10 mg, 30 W
|
1.97 seconds
Standard Deviation 0.65
|
2.83 seconds
Standard Deviation 0.71
|
|
Puff Duration
15 mg, 15 W
|
2.59 seconds
Standard Deviation 0.53
|
4.02 seconds
Standard Deviation 1.27
|
|
Puff Duration
15 mg, 30 W
|
1.65 seconds
Standard Deviation 0.43
|
2.72 seconds
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutesAverage heart rate, measured in beats per minute.
Outcome measures
| Measure |
Cigarette Smokers
n=12 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
E-cigarette Users
n=15 Participants
Each participant will participate in 6 sessions. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Session 1: ECIG Lab Session 15 watts, 10 mg nicotine Session 2: ECIG Lab Session 15 watts, 15 mg nicotine Session 3: ECIG Lab Session 15 watts, 30 mg nicotine Session 4: ECIG Lab Session 30 watts, 10 mg nicotine Session 5: ECIG Lab Session 30 watts, 15 mg nicotine Session 6: ECIG Lab Session 30 watts, 30 mg nicotine
|
|---|---|---|
|
Heart Rate
30 mg, 15 Watts
|
77.12 bpm
Standard Deviation 8.83
|
78.56 bpm
Standard Deviation 12.67
|
|
Heart Rate
30 mg, 30 Watts
|
80.12 bpm
Standard Deviation 8.95
|
84.51 bpm
Standard Deviation 14.79
|
|
Heart Rate
10 mg, 15 Watts
|
75.66 bpm
Standard Deviation 6.88
|
75.01 bpm
Standard Deviation 10.44
|
|
Heart Rate
10 mg, 30 Watts
|
78.19 bpm
Standard Deviation 7.25
|
79.92 bpm
Standard Deviation 15.30
|
|
Heart Rate
15 mg, 15 Watts
|
72.64 bpm
Standard Deviation 6.32
|
79.09 bpm
Standard Deviation 15.30
|
|
Heart Rate
15 mg, 30 Watts
|
76.05 bpm
Standard Deviation 6.91
|
80.27 bpm
Standard Deviation 12.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use periodThe time between each puff, in seconds
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use periodThe rate of air flow during each puff, in ml/second
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approximately 1-hour ad lib use period.This scale is used to assess how product use makes participants feel and consists of 10 questions that are scored 0 - 100. There are no sub-scales. Items are analyzed separately.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.This scale is used to assess how product use makes participants feel, and consists of 10 questions that are scored 0 - 100.There are no sub-scales. Items are analyzed separately.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.Change in carbon monoxide levels (in parts per mission)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Blood pressure will be measured from baseline continuously throughout each approximately 4-hr sessionChange in blood pressure, measured in mm/hg
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: The General Labeled Magnitude Scale will be administered twice in each approximately 4 hour session--after a 5-minute 10 puff use bout, and after the approximately 90 minute ad lib period.This scale measures the flavor sensation, harshness, and throat hit (in three questions that correspond to those constructs) of the e-cigarette used in each session. The scale ranges from 0 - 100, with 0 being no sensation and 100 being the strongest imaginable sensation of any kind. Each item if scored nd analyzed separately (there are no sub-scales).
Outcome measures
Outcome data not reported
Adverse Events
Cigarette Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
E-cigarette Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place