Trial Outcomes & Findings for The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products (NCT NCT03492463)
NCT ID: NCT03492463
Last Updated: 2023-02-08
Results Overview
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on the expired air carbon monoxide (CO) measured at the end of the exposure period (Week 8).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Week 8
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Nicotine E-cigs + Nicotine Patches
Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Nicotine Patches
Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Nicotine E-cigs + Placebo Patches
Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Placebo Patches
Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
33
|
11
|
13
|
|
Overall Study
COMPLETED
|
26
|
19
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products
Baseline characteristics by cohort
| Measure |
Nicotine E-cigs + Nicotine Patches
n=37 Participants
Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Nicotine Patches
n=33 Participants
Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Nicotine E-cigs + Placebo Patches
n=11 Participants
Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Placebo Patches
n=13 Participants
Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 9.4 • n=39 Participants
|
46.0 years
STANDARD_DEVIATION 8.7 • n=41 Participants
|
46.3 years
STANDARD_DEVIATION 12.5 • n=35 Participants
|
45.4 years
STANDARD_DEVIATION 8.7 • n=31 Participants
|
47.2 years
STANDARD_DEVIATION 10.3 • n=146 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
56 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
38 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
94 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
28 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
60 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
94 Participants
n=146 Participants
|
|
Baseline expired air carbon monoxide level
|
30.2 Parts per million (ppm)
STANDARD_DEVIATION 14.3 • n=39 Participants
|
27.7 Parts per million (ppm)
STANDARD_DEVIATION 14.0 • n=41 Participants
|
27.2 Parts per million (ppm)
STANDARD_DEVIATION 13.4 • n=35 Participants
|
28.5 Parts per million (ppm)
STANDARD_DEVIATION 10.7 • n=31 Participants
|
28.7 Parts per million (ppm)
STANDARD_DEVIATION 13.5 • n=146 Participants
|
PRIMARY outcome
Timeframe: Week 8The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on the expired air carbon monoxide (CO) measured at the end of the exposure period (Week 8).
Outcome measures
| Measure |
Nicotine E-cigs + Nicotine Patches
n=26 Participants
Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Nicotine Patches
n=19 Participants
Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Nicotine E-cigs + Placebo Patches
n=7 Participants
Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Placebo Patches
n=10 Participants
Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
|---|---|---|---|---|
|
Expired Air Carbon Monoxide (CO) to Assess Recent Smoking
|
18.3 Parts per million (ppm)
Standard Deviation 16.2
|
22.9 Parts per million (ppm)
Standard Deviation 12.6
|
21.3 Parts per million (ppm)
Standard Deviation 25.7
|
25.6 Parts per million (ppm)
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Week 8Population: Participants with data available at week 8.
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on self-report of cigarette consumption on daily diaries (for week 8 only, average cigarettes smoked per day).
Outcome measures
| Measure |
Nicotine E-cigs + Nicotine Patches
n=27 Participants
Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Nicotine Patches
n=22 Participants
Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Nicotine E-cigs + Placebo Patches
n=7 Participants
Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Placebo Patches
n=10 Participants
Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
|---|---|---|---|---|
|
Cigarette Use, Assessed by Self-report in Daily Dairies
|
9.2 cigarettes smoked per day
Standard Deviation 7.7
|
9.9 cigarettes smoked per day
Standard Deviation 9.0
|
10.3 cigarettes smoked per day
Standard Deviation 12.3
|
9.3 cigarettes smoked per day
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Week 8Population: Participants with data available at week 8.
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of e-cigarettes will be assessed by comparing the groups on self-report of e-cigarette use on daily diaries (for week 8 only).
Outcome measures
| Measure |
Nicotine E-cigs + Nicotine Patches
n=25 Participants
Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Nicotine Patches
n=18 Participants
Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Nicotine E-cigs + Placebo Patches
n=7 Participants
Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Placebo Patches
n=10 Participants
Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
|---|---|---|---|---|
|
E-cigarette Use, Assessed by Self-report in Daily Dairies
|
2.5 e-cigarette pods per day
Standard Deviation 2.6
|
2.0 e-cigarette pods per day
Standard Deviation 2.5
|
3.5 e-cigarette pods per day
Standard Deviation 3.6
|
2.4 e-cigarette pods per day
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week 8Population: Data not collected due to time and budgetary limitations.
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on total urinary NNAL, a metabolite of the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), at the end of week 8.
Outcome measures
Outcome data not reported
Adverse Events
Nicotine E-cigs + Nicotine Patches
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Non-nicotine E-cigs + Nicotine Patches
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Nicotine E-cigs + Placebo Patches
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Non-nicotine E-cigs + Placebo Patches
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicotine E-cigs + Nicotine Patches
n=37 participants at risk
Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Nicotine Patches
n=33 participants at risk
Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Nicotine E-cigs + Placebo Patches
n=11 participants at risk
Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Placebo Patches
n=13 participants at risk
Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Knee Surgery
|
2.7%
1/37 • Number of events 1 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
2.7%
1/37 • Number of events 1 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Renal and urinary disorders
Infected renal stone
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • Number of events 1 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Streptococcal Pneumonia
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
3.0%
1/33 • Number of events 1 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Psychiatric disorders
Auditory Hallucinations
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
3.0%
1/33 • Number of events 1 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
3.0%
1/33 • Number of events 1 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
Other adverse events
| Measure |
Nicotine E-cigs + Nicotine Patches
n=37 participants at risk
Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Nicotine Patches
n=33 participants at risk
Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Nicotine patch: Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Nicotine E-cigs + Placebo Patches
n=11 participants at risk
Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettes: Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
Non-nicotine E-cigs + Placebo Patches
n=13 participants at risk
Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks.
Placebo patch: Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettes: Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.4%
2/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Vascular disorders
Dizziness
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
7.7%
1/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
General disorders
Fatigue
|
5.4%
2/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
General disorders
Insomnia
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
3/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
7.7%
1/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
General disorders
Vivid Dreams
|
18.9%
7/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
18.2%
6/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
27.3%
3/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
7.7%
1/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
General disorders
Dry Mouth
|
5.4%
2/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
2/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
6.1%
2/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
7.7%
1/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Cardiac disorders
Rapid Heart Beat
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
18.2%
2/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
7.7%
1/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
18.2%
2/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
21.6%
8/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
3/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
7.7%
1/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Psychiatric disorders
Irritability
|
5.4%
2/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
6.1%
2/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Skin and subcutaneous tissue disorders
Local Rash
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
6.1%
2/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Skin and subcutaneous tissue disorders
Distant Rash
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
3/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/37 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/33 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
9.1%
1/11 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
0.00%
0/13 • 8 weeks
Adverse events were assessed through systematic approach. Solicited events were tabulated by asking participants to report side effects potentially common in e-cigarette use (e.g. throat irritation) and nicotine patch use (e.g. skin redness). Additionally, unsolicited events were tabulated by asking participants to report on any health concern that may have occurred during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place