Trial Outcomes & Findings for Effects Among Smokers Who Use and Do Not Use E-Cigarettes (NCT NCT03511001)
NCT ID: NCT03511001
Last Updated: 2021-10-12
Results Overview
Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
187 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-10-12
Participant Flow
Participant milestones
| Measure |
E-Cigarette
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
61
|
|
Overall Study
Completers Analyzed
|
114
|
61
|
|
Overall Study
COMPLETED
|
115
|
54
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Baseline characteristics by cohort
| Measure |
E-Cigarette
n=125 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=61 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
41.7 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
43.3 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
92 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 (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=99 Participants
|
61 participants
n=107 Participants
|
186 participants
n=206 Participants
|
|
High school education or less
|
68 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
200% federal poverty level or lower
|
93 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Never married
|
59 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Menthol smoker
|
68 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Duration smoking in years
|
17.5 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
15.5 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
16.8 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Time to first cigarette 30 minutes or less
|
91 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Days smoked in past 7 days
|
6.9 days
STANDARD_DEVIATION 0.5 • n=99 Participants
|
6.7 days
STANDARD_DEVIATION 0.9 • n=107 Participants
|
6.8 days
STANDARD_DEVIATION 0.6 • n=206 Participants
|
|
Cigarettes per day in past 7 days
|
12.4 cigarettes per day
STANDARD_DEVIATION 7.7 • n=99 Participants
|
11.5 cigarettes per day
STANDARD_DEVIATION 6.1 • n=107 Participants
|
12.1 cigarettes per day
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
Days used e-cigarettes in past 7 days
|
0.03 days
STANDARD_DEVIATION 0.28 • n=99 Participants
|
0.08 days
STANDARD_DEVIATION 0.33 • n=107 Participants
|
0.05 days
STANDARD_DEVIATION 0.30 • n=206 Participants
|
|
E-cigarette uses in past 7 days
|
0.05 uses per day
STANDARD_DEVIATION 0.48 • n=99 Participants
|
0.09 uses per day
STANDARD_DEVIATION 0.36 • n=107 Participants
|
0.06 uses per day
STANDARD_DEVIATION 0.45 • n=206 Participants
|
|
History of chronic obstructive pulmonary disorder
|
10 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
History of asthma
|
31 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
History of mental health diagnosis
|
77 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
History of substance abuse
|
64 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Urine cotinine, ng/mL
|
928 ng/mL
n=99 Participants
|
1061 ng/mL
n=107 Participants
|
998 ng/mL
n=206 Participants
|
|
Urine NNAL, pg/mL
|
124 pg/mL
n=99 Participants
|
88 pg/mL
n=107 Participants
|
110 pg/mL
n=206 Participants
|
|
Carbon monoxide, ppm
|
16 ppm
n=99 Participants
|
17 ppm
n=107 Participants
|
17 ppm
n=206 Participants
|
|
Lung function, FEF 25%-75%, L/s
|
3.0 L/s
n=99 Participants
|
2.8 L/s
n=107 Participants
|
3.0 L/s
n=206 Participants
|
|
Respiratory symptoms, number
|
11 units on a scale
n=99 Participants
|
8 units on a scale
n=107 Participants
|
10 units on a scale
n=206 Participants
|
|
Systolic blood pressure
|
130 mm Hg
n=99 Participants
|
129 mm Hg
n=107 Participants
|
129 mm Hg
n=206 Participants
|
|
Diastolic blood pressure
|
81 mm Hg
n=99 Participants
|
83 mm Hg
n=107 Participants
|
82 mm Hg
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.
Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
Outcome measures
| Measure |
E-Cigarette
n=114 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Toxicant Exposure
|
40 pg/ml
Interval 12.0 to 101.0
|
97 pg/ml
Interval 39.0 to 222.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.
Carbon monoxide at week 6. Breath test (PPM)
Outcome measures
| Measure |
E-Cigarette
n=114 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Carbon Monoxide
|
7 ppm
Interval 3.0 to 14.0
|
16 ppm
Interval 9.0 to 25.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.
Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes
Outcome measures
| Measure |
E-Cigarette
n=114 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Respiratory Symptoms
|
7 score on a scale
Interval 3.0 to 12.0
|
9 score on a scale
Interval 4.0 to 16.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.
FEF 25%-75%, L/s at week 6 measured by spirometer
Outcome measures
| Measure |
E-Cigarette
n=114 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Lung Function
|
2.8 L/sec
Interval 1.8 to 4.1
|
2.7 L/sec
Interval 2.1 to 4.1
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.
Systolic blood pressure at week 6
Outcome measures
| Measure |
E-Cigarette
n=114 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Systolic Blood Pressure
|
128 mmHg
Interval 117.0 to 142.0
|
133 mmHg
Interval 122.0 to 143.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.
Diastolic blood pressure at week 6
Outcome measures
| Measure |
E-Cigarette
n=114 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Diastolic Blood Pressure
|
83 mmHg
Interval 74.0 to 89.0
|
83 mmHg
Interval 75.0 to 89.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.
Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes
Outcome measures
| Measure |
E-Cigarette
n=114 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Tobacco Dependence
|
18.5 score on a scale
Interval 15.0 to 36.3
|
41.0 score on a scale
Interval 33.8 to 57.5
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.
Self-efficacy to resist smoking at week 6. Brief Self Efficacy to Resist Smoking Cigarettes Scale; total score ranges from 0-60, higher score reflects better outcome
Outcome measures
| Measure |
E-Cigarette
n=114 Participants
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 Participants
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Self-efficacy to Resist Smoking
|
43.0 score on a scale
Interval 26.5 to 56.0
|
20.0 score on a scale
Interval 12.5 to 30.5
|
Adverse Events
E-Cigarette
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Assessment Only
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
E-Cigarette
n=114 participants at risk
6 weeks of JUUL electronic cigarettes
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
Assessment Only
n=54 participants at risk
6 weeks of smoking as usual
E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dry Mouth/Throat
|
40.4%
46/114 • Number of events 46 • 6 weeks
|
40.7%
22/54 • Number of events 22 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Irritated Mouth/Throat
|
21.1%
24/114 • Number of events 24 • 6 weeks
|
20.4%
11/54 • Number of events 11 • 6 weeks
|
|
Gastrointestinal disorders
Nauseau and/or Vomiting
|
16.7%
19/114 • Number of events 19 • 6 weeks
|
20.4%
11/54 • Number of events 11 • 6 weeks
|
|
Nervous system disorders
Dizziness
|
16.7%
19/114 • Number of events 19 • 6 weeks
|
25.9%
14/54 • Number of events 14 • 6 weeks
|
|
Cardiac disorders
Rapid Heart Rate
|
15.8%
18/114 • Number of events 18 • 6 weeks
|
22.2%
12/54 • Number of events 12 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place