Trial Outcomes & Findings for Examination of Low Wattage and High Wattage E-Cigarettes (NCT NCT03113136)
NCT ID: NCT03113136
Last Updated: 2026-04-17
Results Overview
Self-Reported 7-day Point Prevalence Abstinence from Cigarettes evaluated via the Timeline Follow Back Questionnaire. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
372 participants
Primary outcome timeframe
Week 4, Week 8, Week 12, Week 26, and Week 52
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
Usual Brand Cigarette
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Overall Study
Week 8
|
98
|
86
|
94
|
|
Overall Study
Week 12
|
95
|
84
|
92
|
|
Overall Study
Week 26
|
77
|
69
|
73
|
|
Overall Study
Week 52
|
78
|
67
|
65
|
|
Overall Study
COMPLETED
|
78
|
67
|
65
|
|
Overall Study
NOT COMPLETED
|
27
|
66
|
69
|
|
Overall Study
STARTED
|
105
|
133
|
134
|
|
Overall Study
Week 1
|
101
|
115
|
122
|
|
Overall Study
Week 4
|
99
|
97
|
113
|
Reasons for withdrawal
| Measure |
Usual Brand Cigarette
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
47
|
54
|
|
Overall Study
Withdrawal by Subject
|
4
|
13
|
14
|
|
Overall Study
Ineligible
|
0
|
2
|
1
|
|
Overall Study
Study Team Decision
|
1
|
4
|
0
|
Baseline Characteristics
3 participants were missing data on the number of cigarettes smoked per day at baseline.
Baseline characteristics by cohort
| Measure |
Usual Brand Cigarette
n=105 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=133 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=134 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=105 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=134 Participants
|
1 Participants
n=372 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=105 Participants
|
1 Participants
n=133 Participants
|
0 Participants
n=134 Participants
|
1 Participants
n=372 Participants
|
|
Age, Continuous
|
40.95 years
STANDARD_DEVIATION 10.99 • n=105 Participants
|
39.69 years
STANDARD_DEVIATION 11.05 • n=133 Participants
|
40.47 years
STANDARD_DEVIATION 11.13 • n=134 Participants
|
40.33 years
STANDARD_DEVIATION 11.04 • n=372 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=105 Participants
|
81 Participants
n=133 Participants
|
84 Participants
n=134 Participants
|
233 Participants
n=372 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=105 Participants
|
52 Participants
n=133 Participants
|
50 Participants
n=134 Participants
|
139 Participants
n=372 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=105 Participants
|
1 Participants
n=133 Participants
|
2 Participants
n=134 Participants
|
5 Participants
n=372 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=105 Participants
|
13 Participants
n=133 Participants
|
10 Participants
n=134 Participants
|
36 Participants
n=372 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=105 Participants
|
101 Participants
n=133 Participants
|
113 Participants
n=134 Participants
|
294 Participants
n=372 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=105 Participants
|
13 Participants
n=133 Participants
|
7 Participants
n=134 Participants
|
26 Participants
n=372 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=105 Participants
|
4 Participants
n=133 Participants
|
2 Participants
n=134 Participants
|
9 Participants
n=372 Participants
|
|
Cigarettes Smoked per Day
|
18.13 cigarettes per day
STANDARD_DEVIATION 9.11 • n=103 Participants • 3 participants were missing data on the number of cigarettes smoked per day at baseline.
|
16.86 cigarettes per day
STANDARD_DEVIATION 9.10 • n=133 Participants • 3 participants were missing data on the number of cigarettes smoked per day at baseline.
|
17.33 cigarettes per day
STANDARD_DEVIATION 8.65 • n=133 Participants • 3 participants were missing data on the number of cigarettes smoked per day at baseline.
|
17.38 cigarettes per day
STANDARD_DEVIATION 8.93 • n=369 Participants • 3 participants were missing data on the number of cigarettes smoked per day at baseline.
|
PRIMARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 26, and Week 52Self-Reported 7-day Point Prevalence Abstinence from Cigarettes evaluated via the Timeline Follow Back Questionnaire. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
Outcome measures
| Measure |
Usual Brand Cigarette
n=105 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=133 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=134 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Complete Change From Conventional Cigarettes - Self Report
Week 4
|
0 Participants
|
12 Participants
|
10 Participants
|
|
Complete Change From Conventional Cigarettes - Self Report
Week 8
|
0 Participants
|
19 Participants
|
10 Participants
|
|
Complete Change From Conventional Cigarettes - Self Report
Week 12
|
0 Participants
|
16 Participants
|
16 Participants
|
|
Complete Change From Conventional Cigarettes - Self Report
Week 26
|
5 Participants
|
20 Participants
|
9 Participants
|
|
Complete Change From Conventional Cigarettes - Self Report
Week 52
|
4 Participants
|
13 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 26, and Week 52Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an exhaled carbon monoxide reading less than or equal to 10. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
Outcome measures
| Measure |
Usual Brand Cigarette
n=105 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=133 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=134 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Complete Change From Conventional Cigarettes - Biochemically Verified
Week 4
|
0 Participants
|
10 Participants
|
9 Participants
|
|
Complete Change From Conventional Cigarettes - Biochemically Verified
Week 8
|
0 Participants
|
16 Participants
|
8 Participants
|
|
Complete Change From Conventional Cigarettes - Biochemically Verified
Week 12
|
0 Participants
|
15 Participants
|
11 Participants
|
|
Complete Change From Conventional Cigarettes - Biochemically Verified
Week 26
|
5 Participants
|
18 Participants
|
6 Participants
|
|
Complete Change From Conventional Cigarettes - Biochemically Verified
Week 52
|
4 Participants
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52Population: Participants who attended the study visit and responded to the items in the cigarette dependence scale.
Cigarette Dependence Scale Scores range from 12 to 60 with higher scores indicating greater dependence.
Outcome measures
| Measure |
Usual Brand Cigarette
n=105 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=133 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=134 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Cigarette Dependence
Baseline
|
48.27 score on a scale
Standard Deviation 7.36
|
47.63 score on a scale
Standard Deviation 7.51
|
47.45 score on a scale
Standard Deviation 8.79
|
|
Cigarette Dependence
Week 1
|
48.45 score on a scale
Standard Deviation 6.96
|
43.71 score on a scale
Standard Deviation 8.70
|
43.33 score on a scale
Standard Deviation 9.05
|
|
Cigarette Dependence
Week 4
|
48.90 score on a scale
Standard Deviation 7.57
|
41.89 score on a scale
Standard Deviation 9.74
|
40.21 score on a scale
Standard Deviation 10.13
|
|
Cigarette Dependence
Week 8
|
48.27 score on a scale
Standard Deviation 8.06
|
41.80 score on a scale
Standard Deviation 9.14
|
40.06 score on a scale
Standard Deviation 10.68
|
|
Cigarette Dependence
Week 12
|
48.03 score on a scale
Standard Deviation 7.78
|
41.32 score on a scale
Standard Deviation 9.67
|
40.84 score on a scale
Standard Deviation 9.59
|
|
Cigarette Dependence
Week 26
|
47.00 score on a scale
Standard Deviation 8.72
|
40.67 score on a scale
Standard Deviation 11.27
|
41.15 score on a scale
Standard Deviation 9.57
|
|
Cigarette Dependence
Week 52
|
45.03 score on a scale
Standard Deviation 9.74
|
42.32 score on a scale
Standard Deviation 11.05
|
41.26 score on a scale
Standard Deviation 10.36
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 26, and Week 52Population: Participants who attended the study visit and answered the Cigarette Evaluation Scale items
Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief
Outcome measures
| Measure |
Usual Brand Cigarette
n=105 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=133 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=134 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Cigarette Likeability/Preference
Satisfaction - Baseline
|
4.68 score on a scale
Standard Deviation 1.17
|
5.01 score on a scale
Standard Deviation 1.27
|
4.81 score on a scale
Standard Deviation 1.28
|
|
Cigarette Likeability/Preference
Psychological Reward - Baseline
|
4.30 score on a scale
Standard Deviation 1.13
|
4.54 score on a scale
Standard Deviation 1.36
|
4.13 score on a scale
Standard Deviation 1.49
|
|
Cigarette Likeability/Preference
Aversion - Baseline
|
2.44 score on a scale
Standard Deviation 0.90
|
2.13 score on a scale
Standard Deviation 0.80
|
2.16 score on a scale
Standard Deviation 0.89
|
|
Cigarette Likeability/Preference
Relief - Baseline
|
5.39 score on a scale
Standard Deviation 0.94
|
5.19 score on a scale
Standard Deviation 1.03
|
5.15 score on a scale
Standard Deviation 0.93
|
|
Cigarette Likeability/Preference
Satisfaction - Week 4
|
4.68 score on a scale
Standard Deviation 1.38
|
4.63 score on a scale
Standard Deviation 1.50
|
4.39 score on a scale
Standard Deviation 1.40
|
|
Cigarette Likeability/Preference
Psychological Reward - Week 4
|
4.18 score on a scale
Standard Deviation 1.19
|
4.09 score on a scale
Standard Deviation 1.41
|
3.62 score on a scale
Standard Deviation 1.50
|
|
Cigarette Likeability/Preference
Aversion - Week 4
|
2.25 score on a scale
Standard Deviation 0.90
|
2.28 score on a scale
Standard Deviation 0.86
|
2.43 score on a scale
Standard Deviation 0.91
|
|
Cigarette Likeability/Preference
Relief - Week 4
|
5.38 score on a scale
Standard Deviation 0.97
|
5.19 score on a scale
Standard Deviation 1.06
|
4.88 score on a scale
Standard Deviation 1.10
|
|
Cigarette Likeability/Preference
Satisfaction - Week 12
|
4.74 score on a scale
Standard Deviation 1.50
|
4.26 score on a scale
Standard Deviation 1.61
|
4.27 score on a scale
Standard Deviation 1.68
|
|
Cigarette Likeability/Preference
Psychological Reward - Week 12
|
4.02 score on a scale
Standard Deviation 1.38
|
3.72 score on a scale
Standard Deviation 1.60
|
3.61 score on a scale
Standard Deviation 1.49
|
|
Cigarette Likeability/Preference
Aversion - Week 12
|
2.35 score on a scale
Standard Deviation 1.01
|
2.40 score on a scale
Standard Deviation 0.96
|
2.45 score on a scale
Standard Deviation 0.95
|
|
Cigarette Likeability/Preference
Relief - Week 12
|
5.26 score on a scale
Standard Deviation 1.04
|
5.26 score on a scale
Standard Deviation 1.08
|
4.88 score on a scale
Standard Deviation 1.14
|
|
Cigarette Likeability/Preference
Satisfaction - Week 26
|
4.47 score on a scale
Standard Deviation 1.51
|
4.23 score on a scale
Standard Deviation 1.68
|
4.26 score on a scale
Standard Deviation 1.57
|
|
Cigarette Likeability/Preference
Psychological Reward - Week 26
|
3.92 score on a scale
Standard Deviation 1.38
|
3.69 score on a scale
Standard Deviation 1.51
|
3.53 score on a scale
Standard Deviation 1.42
|
|
Cigarette Likeability/Preference
Aversion - Week 26
|
2.33 score on a scale
Standard Deviation 0.94
|
2.46 score on a scale
Standard Deviation 0.97
|
2.36 score on a scale
Standard Deviation 0.92
|
|
Cigarette Likeability/Preference
Relief - Week 26
|
5.23 score on a scale
Standard Deviation 1.08
|
5.22 score on a scale
Standard Deviation 1.06
|
4.89 score on a scale
Standard Deviation 1.09
|
|
Cigarette Likeability/Preference
Satisfaction - Week 52
|
4.27 score on a scale
Standard Deviation 1.50
|
4.17 score on a scale
Standard Deviation 1.71
|
4.37 score on a scale
Standard Deviation 1.55
|
|
Cigarette Likeability/Preference
Psychological Reward - Week 52
|
3.70 score on a scale
Standard Deviation 1.41
|
3.74 score on a scale
Standard Deviation 1.50
|
3.59 score on a scale
Standard Deviation 1.57
|
|
Cigarette Likeability/Preference
Aversion - Week 52
|
2.32 score on a scale
Standard Deviation 1.00
|
2.68 score on a scale
Standard Deviation 1.07
|
2.42 score on a scale
Standard Deviation 0.89
|
|
Cigarette Likeability/Preference
Relief - Week 52
|
5.26 score on a scale
Standard Deviation 1.23
|
4.96 score on a scale
Standard Deviation 1.18
|
4.84 score on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Week 4, Week 12Population: Participants who attended the study visit and answered the EC modified Cigarette Evaluation Scale items
EC modified-Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief. No results are reported for the Usual Brand Cigarette arm as the participants in this arm did not receive a study e-cigarette device and thus were not asked to respond to the e-cigarette modified cigarette evaluation scale items.
Outcome measures
| Measure |
Usual Brand Cigarette
n=133 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=134 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
EC Likeability/Preference
Satisfaction - Week 4
|
4.67 score on a scale
Standard Deviation 1.28
|
4.63 score on a scale
Standard Deviation 1.50
|
—
|
|
EC Likeability/Preference
Psychological Reward - Week 4
|
2.93 score on a scale
Standard Deviation 1.26
|
2.61 score on a scale
Standard Deviation 1.33
|
—
|
|
EC Likeability/Preference
Aversion - Week 4
|
1.48 score on a scale
Standard Deviation 0.60
|
1.50 score on a scale
Standard Deviation 0.67
|
—
|
|
EC Likeability/Preference
Relief - Week 4
|
4.21 score on a scale
Standard Deviation 1.40
|
4.06 score on a scale
Standard Deviation 1.33
|
—
|
|
EC Likeability/Preference
Satisfaction - Week 12
|
4.44 score on a scale
Standard Deviation 1.47
|
4.65 score on a scale
Standard Deviation 1.61
|
—
|
|
EC Likeability/Preference
Psychological Reward - Week 12
|
2.73 score on a scale
Standard Deviation 1.41
|
2.66 score on a scale
Standard Deviation 1.37
|
—
|
|
EC Likeability/Preference
Aversion - Week 12
|
1.40 score on a scale
Standard Deviation 0.55
|
1.46 score on a scale
Standard Deviation 0.72
|
—
|
|
EC Likeability/Preference
Relief - Week 12
|
4.18 score on a scale
Standard Deviation 1.38
|
4.13 score on a scale
Standard Deviation 1.41
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 12, Week 26, and Week 52Population: For weeks 26 and 52, only participants who reported continued use of the study product were asked the items on the questionnaire.
An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of all three study products. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying.
Outcome measures
| Measure |
Usual Brand Cigarette
n=105 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=133 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=134 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
EC Abuse Liability
Want - Week 4
|
72.08 score on a scale
Standard Deviation 24.50
|
61.87 score on a scale
Standard Deviation 27.34
|
60.43 score on a scale
Standard Deviation 25.04
|
|
EC Abuse Liability
Like - Week 4
|
78.95 score on a scale
Standard Deviation 21.61
|
67.78 score on a scale
Standard Deviation 25.36
|
69.44 score on a scale
Standard Deviation 24.06
|
|
EC Abuse Liability
Enjoy - Week 4
|
79.16 score on a scale
Standard Deviation 20.88
|
68.35 score on a scale
Standard Deviation 24.31
|
67.83 score on a scale
Standard Deviation 24.41
|
|
EC Abuse Liability
Pleasurable - Week 4
|
77.42 score on a scale
Standard Deviation 21.82
|
65.95 score on a scale
Standard Deviation 24.63
|
67.13 score on a scale
Standard Deviation 24.79
|
|
EC Abuse Liability
Satisfying - Week 4
|
82.17 score on a scale
Standard Deviation 17.77
|
63.88 score on a scale
Standard Deviation 23.08
|
65.28 score on a scale
Standard Deviation 23.28
|
|
EC Abuse Liability
Want - Week 12
|
71.47 score on a scale
Standard Deviation 26.43
|
53.59 score on a scale
Standard Deviation 29.50
|
60.45 score on a scale
Standard Deviation 26.85
|
|
EC Abuse Liability
Like - Week 12
|
78.35 score on a scale
Standard Deviation 23.58
|
60.71 score on a scale
Standard Deviation 30.64
|
67.30 score on a scale
Standard Deviation 26.87
|
|
EC Abuse Liability
Enjoy - Week 12
|
79.49 score on a scale
Standard Deviation 21.03
|
60.78 score on a scale
Standard Deviation 30.26
|
66.96 score on a scale
Standard Deviation 26.59
|
|
EC Abuse Liability
Pleasurable - Week 12
|
76.61 score on a scale
Standard Deviation 24.13
|
60.27 score on a scale
Standard Deviation 30.23
|
65.33 score on a scale
Standard Deviation 27.96
|
|
EC Abuse Liability
Satisfying - Week 12
|
82.12 score on a scale
Standard Deviation 19.83
|
57.13 score on a scale
Standard Deviation 29.77
|
62.91 score on a scale
Standard Deviation 27.94
|
|
EC Abuse Liability
Want - Week 26
|
72.69 score on a scale
Standard Deviation 26.08
|
60.53 score on a scale
Standard Deviation 20.04
|
50.23 score on a scale
Standard Deviation 22.95
|
|
EC Abuse Liability
Like - Week 26
|
75.96 score on a scale
Standard Deviation 25.42
|
66.53 score on a scale
Standard Deviation 23.86
|
67.33 score on a scale
Standard Deviation 24.79
|
|
EC Abuse Liability
Enjoy - Week 26
|
71.91 score on a scale
Standard Deviation 27.88
|
68.27 score on a scale
Standard Deviation 18.79
|
65.36 score on a scale
Standard Deviation 25.56
|
|
EC Abuse Liability
Pleasurable - Week 26
|
76.58 score on a scale
Standard Deviation 22.94
|
70.20 score on a scale
Standard Deviation 19.39
|
61.59 score on a scale
Standard Deviation 24.79
|
|
EC Abuse Liability
Satisfying - Week 26
|
79.73 score on a scale
Standard Deviation 20.66
|
68.73 score on a scale
Standard Deviation 20.65
|
60.79 score on a scale
Standard Deviation 24.73
|
|
EC Abuse Liability
Want - Week 52
|
67.56 score on a scale
Standard Deviation 23.57
|
64.55 score on a scale
Standard Deviation 24.79
|
49.23 score on a scale
Standard Deviation 29.38
|
|
EC Abuse Liability
Like - Week 52
|
71.52 score on a scale
Standard Deviation 24.39
|
74.09 score on a scale
Standard Deviation 24.09
|
67.46 score on a scale
Standard Deviation 17.28
|
|
EC Abuse Liability
Enjoy - Week 52
|
74.36 score on a scale
Standard Deviation 21.95
|
73.18 score on a scale
Standard Deviation 27.13
|
65.54 score on a scale
Standard Deviation 20.41
|
|
EC Abuse Liability
Pleasurable - Week 52
|
72.12 score on a scale
Standard Deviation 22.78
|
71.00 score on a scale
Standard Deviation 26.65
|
61.08 score on a scale
Standard Deviation 19.38
|
|
EC Abuse Liability
Satisfying - Week 52
|
77.96 score on a scale
Standard Deviation 21.63
|
74.82 score on a scale
Standard Deviation 25.42
|
65.00 score on a scale
Standard Deviation 17.70
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Participants who provided a urine sample which was able to be analyzed
Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol \[NNAL\] (pmol/mg creatinine)
Outcome measures
| Measure |
Usual Brand Cigarette
n=93 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=71 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=83 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Biomarker of Exposure - NNAL
Baseline
|
3.27 pmol/mg creatinine
Standard Deviation 3.15
|
3.13 pmol/mg creatinine
Standard Deviation 2.55
|
3.20 pmol/mg creatinine
Standard Deviation 2.78
|
|
Biomarker of Exposure - NNAL
Week 4
|
3.09 pmol/mg creatinine
Standard Deviation 2.58
|
2.21 pmol/mg creatinine
Standard Deviation 3.05
|
2.98 pmol/mg creatinine
Standard Deviation 3.05
|
|
Biomarker of Exposure - NNAL
Week 12
|
3.30 pmol/mg creatinine
Standard Deviation 3.59
|
2.20 pmol/mg creatinine
Standard Deviation 2.14
|
2.77 pmol/mg creatinine
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Participants who provided a urine sample which was able to be analyzed
Presence of urinary \[pyridine-D4\]NNN (\[D4\]NNN) (pmol/mg creatinine)
Outcome measures
| Measure |
Usual Brand Cigarette
n=39 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=26 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=30 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Biomarker of Exposure - NNN
Baseline
|
0.07 pmol/mg creatinine
Standard Deviation 0.09
|
0.06 pmol/mg creatinine
Standard Deviation 0.06
|
0.07 pmol/mg creatinine
Standard Deviation 0.09
|
|
Biomarker of Exposure - NNN
Week 4
|
0.06 pmol/mg creatinine
Standard Deviation 0.08
|
0.03 pmol/mg creatinine
Standard Deviation 0.03
|
0.09 pmol/mg creatinine
Standard Deviation 0.11
|
|
Biomarker of Exposure - NNN
Week 12
|
0.05 pmol/mg creatinine
Standard Deviation 0.06
|
0.04 pmol/mg creatinine
Standard Deviation 0.04
|
0.09 pmol/mg creatinine
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Participants who provided a urine sample which was able to be analyzed
Sum of nicotine and metabolites in urine - Total Nicotine Equivalents (TNE) (nmol/mg creatinine)
Outcome measures
| Measure |
Usual Brand Cigarette
n=39 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=26 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=30 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Baseline
|
74.61 nmol/mg creatinine
Standard Deviation 47.28
|
70.18 nmol/mg creatinine
Standard Deviation 42.39
|
69.95 nmol/mg creatinine
Standard Deviation 37.13
|
|
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Week 4
|
77.57 nmol/mg creatinine
Standard Deviation 47.24
|
63.85 nmol/mg creatinine
Standard Deviation 54.88
|
73.44 nmol/mg creatinine
Standard Deviation 34.78
|
|
Biomarker of Exposure - Total Nicotine Equivalents (TNE)
Week 12
|
78.49 nmol/mg creatinine
Standard Deviation 45.29
|
62.81 nmol/mg creatinine
Standard Deviation 33.62
|
69.50 nmol/mg creatinine
Standard Deviation 40.64
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Participants who provided a saliva sample which was able to be analyzed
Metals and metalloids in saliva - Nickel (ng/mL)
Outcome measures
| Measure |
Usual Brand Cigarette
n=69 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=57 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=65 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Biomarker of Exposure - Nickel
Baseline
|
13.31 ng/mL
Standard Deviation 16.13
|
15.59 ng/mL
Standard Deviation 13.95
|
27.44 ng/mL
Standard Deviation 68.28
|
|
Biomarker of Exposure - Nickel
Week 4
|
17.91 ng/mL
Standard Deviation 46.20
|
14.75 ng/mL
Standard Deviation 10.00
|
19.69 ng/mL
Standard Deviation 19.98
|
|
Biomarker of Exposure - Nickel
Week 12
|
13.35 ng/mL
Standard Deviation 9.27
|
14.68 ng/mL
Standard Deviation 9.72
|
18.61 ng/mL
Standard Deviation 19.43
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Participants who provided a saliva sample which was able to be analyzed
Metals and metalloids in saliva - Cadmium (ng/mL)
Outcome measures
| Measure |
Usual Brand Cigarette
n=69 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=57 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=65 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Biomarker of Exposure - Cadmium
Baseline
|
0.25 ng/mL
Standard Deviation 0.30
|
0.34 ng/mL
Standard Deviation 0.55
|
0.36 ng/mL
Standard Deviation 0.41
|
|
Biomarker of Exposure - Cadmium
Week 4
|
0.33 ng/mL
Standard Deviation 0.58
|
0.20 ng/mL
Standard Deviation 0.22
|
0.26 ng/mL
Standard Deviation 0.31
|
|
Biomarker of Exposure - Cadmium
Week 12
|
0.32 ng/mL
Standard Deviation 0.42
|
0.22 ng/mL
Standard Deviation 0.25
|
0.34 ng/mL
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Participants who provided a saliva sample which was able to be analyzed
Metals and metalloids in saliva - Lead (ng/mL)
Outcome measures
| Measure |
Usual Brand Cigarette
n=69 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=57 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=65 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Biomarker of Exposure - Lead
Baseline
|
0.67 ng/mL
Standard Deviation 1.43
|
0.56 ng/mL
Standard Deviation 0.77
|
1.13 ng/mL
Standard Deviation 3.45
|
|
Biomarker of Exposure - Lead
Week 4
|
0.94 ng/mL
Standard Deviation 2.77
|
0.54 ng/mL
Standard Deviation 0.82
|
0.63 ng/mL
Standard Deviation 0.84
|
|
Biomarker of Exposure - Lead
Week 12
|
0.53 ng/mL
Standard Deviation 0.64
|
0.97 ng/mL
Standard Deviation 3.39
|
1.25 ng/mL
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Participants who provided a urine sample which was able to be analyzed
Urinary biomarker of oxidative stress and inflammation - 8-iso-PGF2a (pmol/mg creatinine)
Outcome measures
| Measure |
Usual Brand Cigarette
n=93 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=71 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=83 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Biomarker of Exposure - 8-iso-PGF2a
Baseline
|
1.41 pmol/mg creatinine
Standard Deviation 1.75
|
1.66 pmol/mg creatinine
Standard Deviation 2.28
|
1.18 pmol/mg creatinine
Standard Deviation 1.22
|
|
Biomarker of Exposure - 8-iso-PGF2a
Week 4
|
1.49 pmol/mg creatinine
Standard Deviation 1.40
|
1.73 pmol/mg creatinine
Standard Deviation 1.95
|
4.68 pmol/mg creatinine
Standard Deviation 19.61
|
|
Biomarker of Exposure - 8-iso-PGF2a
Week 12
|
2.51 pmol/mg creatinine
Standard Deviation 3.82
|
2.77 pmol/mg creatinine
Standard Deviation 4.28
|
2.24 pmol/mg creatinine
Standard Deviation 4.15
|
SECONDARY outcome
Timeframe: Week 4, Week 12Population: Participants who provided oral mucosa samples which were able to be analyzed
Data is shown as change in DNA damage from baseline. We calculated change in DNA damage in Transcribed (TS) and Non-transcribed strand (NTS) and added those data points to calculate the Total Change in DNA damage. Results are presented as change in number of DNA lesions per 10,000 base pairs.
Outcome measures
| Measure |
Usual Brand Cigarette
n=77 Participants
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=61 Participants
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=68 Participants
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Biomarker of Effect - q-PADDA
Week 4
|
1.14 Number of DNA lesions/10,000 base pairs
Standard Deviation 7.80
|
-4.30 Number of DNA lesions/10,000 base pairs
Standard Deviation 7.47
|
-3.37 Number of DNA lesions/10,000 base pairs
Standard Deviation 7.80
|
|
Biomarker of Effect - q-PADDA
Week 12
|
-0.10 Number of DNA lesions/10,000 base pairs
Standard Deviation 8.80
|
-5.40 Number of DNA lesions/10,000 base pairs
Standard Deviation 8.81
|
-4.10 Number of DNA lesions/10,000 base pairs
Standard Deviation 6.18
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Although participant samples were collected, they were not analyzed to determine the nicotine metabolite ratio due to budget reductions for this study. There are no plans to analyze NMR in these samples in the future.
Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine \[3HC\]/cotinine)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12Population: Although participant urine samples were collected, they were not analyzed to determine the PGEM due to budget reductions for this study. There are no plans to analyze the PGEM in these samples in the future.
Urinary biomarker of oxidative stress and inflammation
Outcome measures
Outcome data not reported
Adverse Events
Usual Brand Cigarette
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Low Wattage E Cigarette Device
Serious events: 2 serious events
Other events: 103 other events
Deaths: 0 deaths
High Wattage E Cigarette Device
Serious events: 2 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Brand Cigarette
n=105 participants at risk
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=133 participants at risk
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=134 participants at risk
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Cardiac disorders
Stroke
|
0.95%
1/105 • 1 year
|
0.00%
0/133 • 1 year
|
0.00%
0/134 • 1 year
|
|
Cardiac disorders
High Blood Pressure
|
0.95%
1/105 • 1 year
|
0.00%
0/133 • 1 year
|
0.00%
0/134 • 1 year
|
|
Cardiac disorders
Blood Clot
|
0.95%
1/105 • 1 year
|
0.00%
0/133 • 1 year
|
0.00%
0/134 • 1 year
|
|
Skin and subcutaneous tissue disorders
Possible Skin Cancer
|
0.95%
1/105 • 1 year
|
0.00%
0/133 • 1 year
|
0.00%
0/134 • 1 year
|
|
Cardiac disorders
Heart Attack
|
0.95%
1/105 • 1 year
|
0.00%
0/133 • 1 year
|
0.00%
0/134 • 1 year
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/105 • 1 year
|
0.75%
1/133 • 1 year
|
0.00%
0/134 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Knee Surgery
|
0.00%
0/105 • 1 year
|
0.75%
1/133 • 1 year
|
0.00%
0/134 • 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/105 • 1 year
|
0.75%
1/133 • 1 year
|
0.00%
0/134 • 1 year
|
|
Nervous system disorders
Loss of feeling in mouth and jaw
|
0.00%
0/105 • 1 year
|
0.00%
0/133 • 1 year
|
0.75%
1/134 • 1 year
|
|
Cardiac disorders
Sharp Chest Pains
|
0.00%
0/105 • 1 year
|
0.00%
0/133 • 1 year
|
0.75%
1/134 • 1 year
|
Other adverse events
| Measure |
Usual Brand Cigarette
n=105 participants at risk
Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
|
Low Wattage E Cigarette Device
n=133 participants at risk
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
High Wattage E Cigarette Device
n=134 participants at risk
High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
|
|---|---|---|---|
|
Immune system disorders
Allergies
|
8.6%
9/105 • 1 year
|
9.8%
13/133 • 1 year
|
7.5%
10/134 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Difficulties
|
21.9%
23/105 • 1 year
|
18.0%
24/133 • 1 year
|
17.2%
23/134 • 1 year
|
|
General disorders
Chest Pain
|
2.9%
3/105 • 1 year
|
5.3%
7/133 • 1 year
|
0.75%
1/134 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
55.2%
58/105 • 1 year
|
51.1%
68/133 • 1 year
|
58.2%
78/134 • 1 year
|
|
Nervous system disorders
Dizziness
|
8.6%
9/105 • 1 year
|
10.5%
14/133 • 1 year
|
9.7%
13/134 • 1 year
|
|
Gastrointestinal disorders
Sore or Dry Mouth and Throat
|
23.8%
25/105 • 1 year
|
33.1%
44/133 • 1 year
|
34.3%
46/134 • 1 year
|
|
Gastrointestinal disorders
Gingivitis
|
4.8%
5/105 • 1 year
|
8.3%
11/133 • 1 year
|
5.2%
7/134 • 1 year
|
|
Nervous system disorders
Headache
|
9.5%
10/105 • 1 year
|
13.5%
18/133 • 1 year
|
17.2%
23/134 • 1 year
|
|
Gastrointestinal disorders
Mouth or Tongue Sores / Inflammation
|
1.9%
2/105 • 1 year
|
5.3%
7/133 • 1 year
|
7.5%
10/134 • 1 year
|
|
Nervous system disorders
Sleepiness
|
6.7%
7/105 • 1 year
|
5.3%
7/133 • 1 year
|
6.7%
9/134 • 1 year
|
|
Psychiatric disorders
Sleeplessness
|
14.3%
15/105 • 1 year
|
9.0%
12/133 • 1 year
|
13.4%
18/134 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place