Trial Outcomes & Findings for Changes in Biomarkers Associated With Use of Electronic Cigarettes (NCT NCT03084315)
NCT ID: NCT03084315
Last Updated: 2021-08-26
Results Overview
Change in concentration of nicotine equivalents in units of mmol/mg creatinine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
234 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2021-08-26
Participant Flow
Participant milestones
| Measure |
E-Cig Zero Nicotine
E-Cigarette with no nicotine added
E-Cig Zero Nicotine: E-Cig Zero Nicotine
|
E-Cig 24mg Nicotine
E-cigarette with 24mg of nicotine added
E-Cig 24mg Nicotine: E-Cig 24mg Nicotine
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
118
|
|
Overall Study
COMPLETED
|
106
|
109
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
| Measure |
E-Cig Zero Nicotine
E-Cigarette with no nicotine added
E-Cig Zero Nicotine: E-Cig Zero Nicotine
|
E-Cig 24mg Nicotine
E-cigarette with 24mg of nicotine added
E-Cig 24mg Nicotine: E-Cig 24mg Nicotine
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Changes in Biomarkers Associated With Use of Electronic Cigarettes
Baseline characteristics by cohort
| Measure |
E-Cig Zero Nicotine
n=114 Participants
E-Cigarette with no nicotine added
E-Cig Zero Nicotine: E-Cig Zero Nicotine
|
E-Cig 24mg Nicotine
n=116 Participants
E-cigarette with 24mg of nicotine added
E-Cig 24mg Nicotine: E-Cig 24mg Nicotine
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Continuous
|
50.74 years
STANDARD_DEVIATION 11.65 • n=99 Participants
|
50.89 years
STANDARD_DEVIATION 10.74 • n=107 Participants
|
50.81 years
STANDARD_DEVIATION 11.18 • n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
111 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
224 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=99 Participants
|
116 participants
n=107 Participants
|
230 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Change in concentration of nicotine equivalents in units of mmol/mg creatinine.
Outcome measures
| Measure |
E-Cig Zero Nicotine
n=114 Participants
E-Cigarette with no nicotine added
E-Cig Zero Nicotine: E-Cig Zero Nicotine
|
E-Cig 24mg Nicotine
n=116 Participants
E-cigarette with 24mg of nicotine added
E-Cig 24mg Nicotine: E-Cig 24mg Nicotine
|
|---|---|---|
|
Change in Biomarker Concentrations: Nicotine Equivalents
|
74.9 mmol/mg creatinine
Standard Deviation 57.23
|
79.56 mmol/mg creatinine
Standard Deviation 72.8
|
PRIMARY outcome
Timeframe: Baseline, Week 6Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine.
Outcome measures
| Measure |
E-Cig Zero Nicotine
n=106 Participants
E-Cigarette with no nicotine added
E-Cig Zero Nicotine: E-Cig Zero Nicotine
|
E-Cig 24mg Nicotine
n=109 Participants
E-cigarette with 24mg of nicotine added
E-Cig 24mg Nicotine: E-Cig 24mg Nicotine
|
|---|---|---|
|
Change in Biomarker Concentrations: NNAL
|
1.98 pmol/mg creatinine
Standard Deviation 1.74
|
1.95 pmol/mg creatinine
Standard Deviation 1.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 6Participants will record the average number of cigarettes smoked per day in the 7 days leading up to each study visit. Outcome is reported as the change in average cigarettes per day from baseline to 6 weeks of treatment.
Outcome measures
| Measure |
E-Cig Zero Nicotine
n=114 Participants
E-Cigarette with no nicotine added
E-Cig Zero Nicotine: E-Cig Zero Nicotine
|
E-Cig 24mg Nicotine
n=116 Participants
E-cigarette with 24mg of nicotine added
E-Cig 24mg Nicotine: E-Cig 24mg Nicotine
|
|---|---|---|
|
Change in Average Cigarettes Per Day
|
8.8 cigarettes/day
Standard Deviation 6.3
|
8.6 cigarettes/day
Standard Deviation 6.3
|
Adverse Events
E-Cig Zero Nicotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
E-Cig 24mg Nicotine
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