Trial Outcomes & Findings for Low Nicotine Cigarettes Plus Electronic Cigarettes (NCT NCT04058717)
NCT ID: NCT04058717
Last Updated: 2025-09-11
Results Overview
Measure of tobacco-specific nitrosamine
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
Week 16
Results posted on
2025-09-11
Participant Flow
88 participants consented and enrolled in the pre-randomization phase of the study. Eight participants were lost to follow-up or withdrawn from the study before being randomized to a study intervention. Therefore, 80 participants were randomized to a study intervention.
Participant milestones
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Randomization Period
STARTED
|
20
|
20
|
20
|
20
|
|
Randomization Period
COMPLETED
|
17
|
13
|
13
|
13
|
|
Randomization Period
NOT COMPLETED
|
3
|
7
|
7
|
7
|
|
Week 20 Follow up
STARTED
|
17
|
13
|
13
|
13
|
|
Week 20 Follow up
COMPLETED
|
15
|
13
|
13
|
11
|
|
Week 20 Follow up
NOT COMPLETED
|
2
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Randomization Period
Lost to Follow-up
|
2
|
3
|
4
|
4
|
|
Randomization Period
Withdrawal by Subject
|
1
|
3
|
3
|
3
|
|
Randomization Period
PI decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Low Nicotine Cigarettes Plus Electronic Cigarettes
Baseline characteristics by cohort
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=20 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=20 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=20 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=20 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 9 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
46.9 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
|
Cigarettes per day
|
22 cigarettes per day
STANDARD_DEVIATION 11.7 • n=5 Participants
|
18.8 cigarettes per day
STANDARD_DEVIATION 9.9 • n=7 Participants
|
22.4 cigarettes per day
STANDARD_DEVIATION 8.6 • n=5 Participants
|
17.6 cigarettes per day
STANDARD_DEVIATION 9.8 • n=4 Participants
|
20.2 cigarettes per day
STANDARD_DEVIATION 10.1 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The Overall Number of Participants Analyzed includes participants with non-missing values at Week 16. Therefore, in one of the groups, 20 people were randomized and 13 people completed the randomization phase, but only 12 of the samples could be analyzed.
Measure of tobacco-specific nitrosamine
Outcome measures
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=17 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=13 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=12 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=13 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)
|
505.6 pg/mg creatinine
Standard Deviation 432.7
|
459.1 pg/mg creatinine
Standard Deviation 312.8
|
373.3 pg/mg creatinine
Standard Deviation 553.1
|
180.5 pg/mg creatinine
Standard Deviation 218.2
|
SECONDARY outcome
Timeframe: Week 16Population: The Overall Number of Participants Analyzed includes participants with non-missing values at Week 16. In two of the groups, 1 person had missing CO values.
Measure of cigarette smoke exposure
Outcome measures
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=17 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=12 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=12 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=13 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Exhaled Carbon Monoxide
|
23.6 parts per million
Standard Deviation 9.4
|
25.2 parts per million
Standard Deviation 14.6
|
21.9 parts per million
Standard Deviation 24.5
|
12.6 parts per million
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Week 16Population: The Overall Number of Participants Analyzed includes all participants with non-missing values at Week 16. In the VLNC cigarettes + High Nicotine Containing E-cigarette group, two participants did not complete the entire Week 16 visit, but they did complete the Kessler-6 survey for Week 16. Therefore, their Kessler-6 survey data are included in this analysis even though they were not included in the final sample size for Week 16, resulting in a sample size of n=15 for this group.
Measure of serious psychological distress. This scale is a brief, self-report tool used to assess psychological distress. Scores range from 0-24, with higher scores indicating greater distress
Outcome measures
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=17 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=13 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=15 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=13 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Kessler-6 Score
|
6.9 score on a scale
Standard Deviation 5.9
|
5.7 score on a scale
Standard Deviation 5.1
|
5.4 score on a scale
Standard Deviation 5.9
|
5.9 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Week 16Population: The Overall Number of Participants Analyzed includes everyone with non-missing values at Week 16. In the VLNC cig+High Nic E-cig group, 1 person did not complete the entire Week 16 visit, but they did complete the Cig Dep survey for Week 16. Therefore, their Cig Dep survey data are included in this analysis, even though they were not included in the final sample size for Week 16, resulting in a sample size of n=14 for this group. 1 person had missing data in the VLNC cig+Zero Nic E-cig.
Measure of cigarette dependence. This 10-item scale (with scores ranging from 0 to 20) was developed to measure cigarette dependence, where a score of 0 indicates no cigarette dependence and 20 indicates maximum cigarette dependence.
Outcome measures
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=17 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=13 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=14 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=12 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Penn State Cigarette Dependence Index
|
11.9 score on a scale
Standard Deviation 3
|
11.5 score on a scale
Standard Deviation 2.9
|
11.8 score on a scale
Standard Deviation 4.3
|
9.4 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Week 16Population: The Overall Number of Participants Analyzed includes everyone with non-missing values at Week 16. In the VLNC cig+High Nic E-cig group, 1 person did not complete the entire Week 16 visit, but they did complete the E-cig Dep survey for Week 16. Therefore, their E-cig Dep survey data are included in this analysis, even though they were not included in the final sample size for Week 16, resulting in a sample size of n=14 for this group. 2 people had missing data in the VLNC cig+0 Nic E-cig group.
Measure of e-cigarette dependence. This 10-item scale (with scores ranging from 0 to 20) was developed to measure e-cigarette dependence, where a score of 0 indicates no cigarette dependence and 20 indicates maximum e-cigarette dependence.
Outcome measures
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=17 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=13 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=14 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=11 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Penn State Electronic Cigarette Dependence Index
|
3.1 score on a scale
Standard Deviation 3
|
5.8 score on a scale
Standard Deviation 3.8
|
8.1 score on a scale
Standard Deviation 5.2
|
5.8 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Week 20Population: This is an intent-to-treat analysis so everyone who was randomized was included in the sample analyzed, regardless of whether they completed the Week 20 assessment. Those who did not complete the Week 20 assessment were assumed to be non-abstainers. This is normal practice in smoking cessation research.
No cigarette use in the past 7 days and exhaled carbon monoxide \< 6ppm
Outcome measures
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=20 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=20 Participants
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=20 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=20 Participants
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Cigarette Abstinence
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
Adverse Events
NNC Cigarettes + High Nicotine Containing E-cigarette
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
NNC Cigarettes + Zero Nicotine Containing E-cigarette
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
VLNC Cigarettes + High Nicotine Containing E-cigarette
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=20 participants at risk
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=20 participants at risk
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=20 participants at risk
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=20 participants at risk
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/20 • 20 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%
0/20 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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
Upper respiratory infection
|
0.00%
0/20 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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%
0/20 • 20 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.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy loss
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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%
0/20 • 20 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%
0/20 • 20 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
Lung infection
|
0.00%
0/20 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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%
0/20 • 20 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
Clostridium difficile infection
|
0.00%
0/20 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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%
0/20 • 20 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.
|
|
Psychiatric disorders
Self-injurious ideation
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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%
0/20 • 20 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%
0/20 • 20 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.
|
|
Surgical and medical procedures
Surgical and Medical Procedures, other back electrodes
|
0.00%
0/20 • 20 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%
0/20 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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
Infections and infestations - Other, influenza
|
0.00%
0/20 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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%
0/20 • 20 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.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/20 • 20 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%
0/20 • 20 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%
0/20 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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.
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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%
0/20 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • 20 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%
0/20 • 20 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%
0/20 • 20 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%
0/20 • 20 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 |
NNC Cigarettes + High Nicotine Containing E-cigarette
n=20 participants at risk
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
|
NNC Cigarettes + Zero Nicotine Containing E-cigarette
n=20 participants at risk
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Normal Nicotine Content research cigarettes: Research cigarettes with 11.6 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
VLNC Cigarettes + High Nicotine Containing E-cigarette
n=20 participants at risk
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
High Nicotine e-cigarette: E-cigarette containing high nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
|
VLNC Cigarettes + Zero Nicotine Containing E-cigarette
n=20 participants at risk
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Very Low Nicotine Content research cigarettes: Research cigarettes with 0.2 mg nicotine/cigarette.
Zero Nicotine e-cigarette: E-cigarette containing zero nicotine e-liquid
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • 20 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.
|
15.0%
3/20 • Number of events 3 • 20 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%
0/20 • 20 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.
|
15.0%
3/20 • Number of events 3 • 20 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.
|
|
Psychiatric disorders
Suicidal ideation
|
5.0%
1/20 • Number of events 1 • 20 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.
|
25.0%
5/20 • Number of events 5 • 20 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.
|
20.0%
4/20 • Number of events 4 • 20 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.
|
10.0%
2/20 • Number of events 2 • 20 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.
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • Number of events 2 • 20 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.
|
10.0%
2/20 • Number of events 2 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Number of events 2 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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.
|
5.0%
1/20 • Number of events 1 • 20 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.
|
10.0%
2/20 • Number of events 2 • 20 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