Trial Outcomes & Findings for Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers (NCT NCT03625986)
NCT ID: NCT03625986
Last Updated: 2025-03-27
Results Overview
Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
6-week visit (post-treatment)
Results posted on
2025-03-27
Participant Flow
One participant was excluded from the study before their assignment to a group because she did not meet the eligibility criteria for blood pressure.
Participant milestones
| Measure |
Nicotine-Containing Electronic Cigarette
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Randomization Period
STARTED
|
52
|
52
|
|
Randomization Period
COMPLETED
|
35
|
34
|
|
Randomization Period
NOT COMPLETED
|
17
|
18
|
|
10 Week Post-treatment
STARTED
|
35
|
34
|
|
10 Week Post-treatment
COMPLETED
|
34
|
34
|
|
10 Week Post-treatment
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Nicotine-Containing Electronic Cigarette
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
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|---|---|---|
|
Randomization Period
Lost to Follow-up
|
7
|
12
|
|
Randomization Period
Withdrawal by Subject
|
10
|
6
|
Baseline Characteristics
Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers
Baseline characteristics by cohort
| Measure |
Nicotine-Containing Electronic Cigarette
n=52 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=52 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
52 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Education
High school or less
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Education
Greater than high school
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-week visit (post-treatment)Population: Four missing values because sample could not be analyzed
Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=33 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=32 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Urinary NNAL Concentration
|
151.6 ng/ml
Standard Deviation 235.1
|
338.2 ng/ml
Standard Deviation 270.1
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Forced expiratory volume in one second (FEV1).
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=35 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=34 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Pulmonary Function
|
2.7 liters
Standard Deviation 0.8
|
2.7 liters
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Exhaled CO (parts per million \[ppm\])
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=35 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=34 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Exhaled Carbon Monoxide (CO)
|
10.7 ppm
Standard Deviation 18.8
|
13.8 ppm
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: Three missing values because sample could not be analyzed
Cotinine (ng/ml) will serve as a measure of exposure to nicotine.
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=33 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=33 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Urine Cotinine Concentration
|
5295.7 ng/ml
Standard Deviation 5123.3
|
2879.7 ng/ml
Standard Deviation 2481.5
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)systolic blood pressure in mm Hg
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=35 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=34 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Blood Pressure
|
125.91 mmHg
Standard Deviation 15.74
|
124.74 mmHg
Standard Deviation 12.13
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: Questionnaire was only given to participants who used cigarettes in the past 7 days
Nicotine dependence for cigarettes will be assessed via the Fagerstrom Test for Nicotine Dependence (FTND), a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence).
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=16 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=25 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Fagerstrom Test for Nicotine Dependence Mean Total Score
|
3.69 score on a scale
Standard Deviation 2.68
|
3.2 score on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: Questionnaire was only given to participants who used the e-cigarette in the past 7 days
Nicotine dependence for e-cigarettes will be assessed via the Penn State Electronic Nicotine Dependence Index, a measure with total scores ranging from 0 (very low dependence) to 20 (very high dependence).
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=33 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=29 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Penn State Electronic Cigarette Dependence Index
|
7.21 score on a scale
Standard Deviation 3.68
|
5.45 score on a scale
Standard Deviation 3.47
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: Missing data for cigarettes per day for two participants
Mean number of cigarettes smoked per day based on the past 7 days
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=33 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=34 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Cigarettes Per Day
|
3.78 cigarettes per day
Standard Deviation 6.75
|
4.74 cigarettes per day
Standard Deviation 5.21
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: This is an intent-to-treat analysis so everyone who was randomized was included in the sample analyzed
Zero cigarettes or other tobacco products (not including e-cigs) used in the past 7 days and a CO \<6ppm
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=52 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=52 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Number of Participants With Abstinence From Cigarettes and Other Tobacco (Not Including E-cigs)
|
19 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-week visit (post-treatment)Withdrawal and craving will be assessed via the Minnesota Nicotine Withdrawal Scale. Total scores range from 0-28. Higher scores indicate worse withdrawal symptoms.
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=44 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=45 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Total Score on Minnesota Nicotine Withdrawal Scale
|
4.2 score on a scale
Standard Deviation 4.89
|
6.16 score on a scale
Standard Deviation 5.89
|
SECONDARY outcome
Timeframe: 10-week visit (post-treatment)Mean number of cigarettes smoked per day based on the past 7 days
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=34 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=34 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Cigarettes Per Day
|
5.03 cigarettes per day
Standard Deviation 8.04
|
6.47 cigarettes per day
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: 10-week visit (post-treatment)Population: Data missing from participant six participants
The number of days the e-cig was used since 6-week visit (post-treatment)
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=29 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=34 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
E-cig Use Days
|
6.69 days
Standard Deviation 10.57
|
2.88 days
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: 10-week visit (post-treatment)Abstinence will be considered zero cigarettes and other tobacco products (not including e-cigs) in the past 7 days
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=34 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=34 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Number of Participants With Self-reported Abstinence
|
20 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: Five participants had missing data due to EKG not functioning and/or low quality data
Heart Rate Variability (HRV) will be assessed from resting Holter EKG output.
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=32 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=32 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Heart Rate Variability (HRV)
|
35.2 msec
Standard Deviation 17.8
|
34.6 msec
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: Five participants had missing data due to EKG not functioning and/or low quality data
Presence of PVCs will be assessed from resting Holter EKG output.
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=32 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=32 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Presence of Premature Ventricular Contractions (PVCs)
|
2 count of PVCs
Standard Deviation 6.8
|
2.3 count of PVCs
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: Six participants had missing data due to EKG not functioning and/or low quality data
ST-Elevation will be assessed from resting Holter EKG output
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=31 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=32 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
ST-Elevation
|
103.1 µV
Standard Deviation 97.2
|
87.8 µV
Standard Deviation 50.5
|
SECONDARY outcome
Timeframe: 6-week visit (post-treatment)Population: Six participants had missing data due to EKG not functioning and/or low quality data
QRS duration will be assessed from resting Holter EKG output.
Outcome measures
| Measure |
Nicotine-Containing Electronic Cigarette
n=31 Participants
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=32 Participants
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
QRS Duration
|
94.3 msec
Standard Deviation 9.2
|
98.3 msec
Standard Deviation 10.4
|
Adverse Events
Nicotine-Containing Electronic Cigarette
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Non-Nicotine Electronic Cigarette
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicotine-Containing Electronic Cigarette
n=52 participants at risk
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=52 participants at risk
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Cardiac disorders
Stroke
|
1.9%
1/52 • Number of events 1 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
0.00%
0/52 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
Other adverse events
| Measure |
Nicotine-Containing Electronic Cigarette
n=52 participants at risk
The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks.
Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.
|
Non-Nicotine Electronic Cigarette
n=52 participants at risk
The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks.
Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
3.8%
2/52 • Number of events 2 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
|
Infections and infestations
COVID-19
|
5.8%
3/52 • Number of events 3 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
1.9%
1/52 • Number of events 1 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
|
Nervous system disorders
Dizziness
|
3.8%
2/52 • Number of events 2 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
0.00%
0/52 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
4/52 • Number of events 4 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
1.9%
1/52 • Number of events 1 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
|
Nervous system disorders
Headache
|
3.8%
2/52 • Number of events 2 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
7.7%
4/52 • Number of events 5 • 10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place