Trial Outcomes & Findings for Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors (NCT NCT03185546)
NCT ID: NCT03185546
Last Updated: 2021-05-14
Results Overview
The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
Week 10 through Week 12
Results posted on
2021-05-14
Participant Flow
There were 106 screen failures.
Participant milestones
| Measure |
Normal Nicotine Content (NNC) Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
Very Low Nicotine Content (VLNC) Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
|---|---|---|---|---|---|---|---|---|
|
Baseline Through Week 12
STARTED
|
6
|
10
|
5
|
5
|
6
|
6
|
7
|
5
|
|
Baseline Through Week 12
COMPLETED
|
2
|
7
|
4
|
4
|
5
|
4
|
4
|
2
|
|
Baseline Through Week 12
NOT COMPLETED
|
4
|
3
|
1
|
1
|
1
|
2
|
3
|
3
|
|
Week 12 Through Day 30 Follow up
STARTED
|
2
|
7
|
4
|
4
|
5
|
4
|
4
|
2
|
|
Week 12 Through Day 30 Follow up
COMPLETED
|
2
|
7
|
4
|
3
|
5
|
4
|
3
|
2
|
|
Week 12 Through Day 30 Follow up
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors
Baseline characteristics by cohort
| Measure |
NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors
n=6 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=7 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors
n=6 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor
n=6 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=5 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=5 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors
n=10 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=5 Participants
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 7.7 • n=93 Participants
|
43.1 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
45.2 years
STANDARD_DEVIATION 14.4 • n=27 Participants
|
37.8 years
STANDARD_DEVIATION 11.7 • n=483 Participants
|
42.8 years
STANDARD_DEVIATION 15.9 • n=36 Participants
|
38 years
STANDARD_DEVIATION 7.0 • n=10 Participants
|
40.5 years
STANDARD_DEVIATION 13.3 • n=115 Participants
|
43.8 years
STANDARD_DEVIATION 11.1 • n=40 Participants
|
41.6 years
STANDARD_DEVIATION 11.7 • n=8 Participants
|
|
Sex/Gender, Customized
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
20 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
29 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
46 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
30 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown/Prefer Not to Answer
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
7 participants
n=4 Participants
|
6 participants
n=27 Participants
|
6 participants
n=483 Participants
|
5 participants
n=36 Participants
|
5 participants
n=10 Participants
|
10 participants
n=115 Participants
|
5 participants
n=40 Participants
|
50 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 10 through Week 12The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).
Outcome measures
| Measure |
NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors
n=2 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors
n=4 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor
n=5 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors
n=7 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=2 Participants
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
|---|---|---|---|---|---|---|---|---|
|
Total Cigarettes Smoked Per Day
|
21.6 number of cigarettes
Standard Deviation 3.7
|
7.7 number of cigarettes
Standard Deviation 12.1
|
18.4 number of cigarettes
Standard Deviation 8
|
12.5 number of cigarettes
Standard Deviation 16.3
|
34 number of cigarettes
Standard Deviation 14.8
|
18.7 number of cigarettes
Standard Deviation 13.9
|
17.7 number of cigarettes
Standard Deviation 8.5
|
15.8 number of cigarettes
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline - Week 12Measure of cigarette smoke exposure using data on expired breath CO. CO was captured using Covita Smokelyzer devices and standard exhalation procedures. The unit of measurement is parts per million (ppm).
Outcome measures
| Measure |
NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors
n=2 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors
n=4 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor
n=5 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors
n=7 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=2 Participants
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
|---|---|---|---|---|---|---|---|---|
|
Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)
|
31 parts per million (ppm)
Standard Deviation 19.8
|
7.2 parts per million (ppm)
Standard Deviation 3.8
|
18 parts per million (ppm)
Standard Deviation 7.4
|
12 parts per million (ppm)
Standard Deviation 7
|
18.2 parts per million (ppm)
Standard Deviation 3.4
|
21 parts per million (ppm)
Standard Deviation 7.8
|
18.3 parts per million (ppm)
Standard Deviation 7.7
|
32.5 parts per million (ppm)
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: Baseline-Week 12Study team generates the smoke free days outcome by counting days where no cigarettes and no other forms of combusted tobacco products are used. Days where participants use no nicotine products and days where participants only vape are "smoke free." Percentage of smoke free days = the number days that participants reported smoking 0 cigarettes (0 study cigarettes and 0 non-study cigarettes) divided by the total number of days between their randomization and Week 12 visits. Due to the distribution of the data, statisticians grouped participants according to whether they had 0 smoke-free days or more than 0 smoke free days during the study.
Outcome measures
| Measure |
NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors
n=2 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors
n=4 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor
n=5 Participants
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=4 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors
n=7 Participants
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=2 Participants
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Smoke Free Days
Subjects with 0% smoke free days
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
4 participants
|
3 participants
|
6 participants
|
0 participants
|
|
Number of Subjects With Smoke Free Days
Subjects with more than 0% smoke free days
|
1 participants
|
3 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of discomfort and dysfunction; 15-item self-reported scale to evaluate the effects of smoking cessation. Score ranges from 0 to 60 with higher score denoting more severe symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12collected through Interactive Voice Response (IVR) Review
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Assesses the extent to which the product they just sampled produced various subjective effects including satisfaction, good taste, dizziness, reduced appetite, nausea, and enjoyable sensations in the throat and chest. Score ranges from 1 to 91 with a higher score denoting more positive sensations.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of toxicant exposure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Dependence Measure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Study cigarettes smoked per day
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of vaping device use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 00Measure of relative reinforcement
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Measure of relative reinforcement and substitution
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Measure of hypothetical cigarette and vaping device use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of compliance
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Drop-out rate
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of discomfort and dysfunction
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 04, 08, 12Measure of discomfort and dysfunction
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline - Week 12Alcohol use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Drug use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Alcohol use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Drug use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Weight
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline -Week 12Measure of cigarette exposure and compliance
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline - Week 12Measure of nicotine exposure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of smoking and vaping context
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of smoking and vaping context
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 01 and 10Measure of smoking and vaping topography
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Measure of product expectancy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of product expectancy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of product characteristics
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of perceived personal health risk
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Dependence Measure (smoking and vaping)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Dependence Measure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Dependence Measure (smoking and vaping)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of intention to quit
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of intention to quit
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 12Measure of intention to quit
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 Day Follow upMeasure of 30-day tobacco use post-intervention of study products
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 Day Follow upThemes related to product use patterns, e-liquid flavor selection, non-compliance and general study feedback
Outcome measures
Outcome data not reported
Adverse Events
NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pre-Randomization
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors
n=6 participants at risk
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=7 participants at risk
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors
n=6 participants at risk
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor
n=6 participants at risk
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=5 participants at risk
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=5 participants at risk
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors
n=10 participants at risk
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=5 participants at risk
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
Pre-Randomization
n=106 participants at risk
Participants signed consent but screen failed before randomizing into study
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Skin Infection
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Immune system disorders
anaphylaxis
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
Other adverse events
| Measure |
NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors
n=6 participants at risk
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=7 participants at risk
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors
n=6 participants at risk
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor
n=6 participants at risk
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
NNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=5 participants at risk
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors
n=5 participants at risk
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors
n=10 participants at risk
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors
|
VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors
n=5 participants at risk
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
|
Pre-Randomization
n=106 participants at risk
Participants signed consent but screen failed before randomizing into study
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph Node, pain (swollen)
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Cardiac disorders
Bradycardia (slow heart rate)
|
16.7%
1/6 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Ear and labyrinth disorders
Ear Pain (ache/fullness)
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Ear and labyrinth disorders
Tingling sensation left ear
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Dry Mouth
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Tooth Ache
|
33.3%
2/6 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
40.0%
2/5 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia (upset stomach)
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Gastrointestinal disorders
Gastroesophageal Reflux (GERD/heartburn/acid)
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
40.0%
2/5 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 3 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.94%
1/106 • Number of events 1 • Baseline through 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.94%
1/106 • Number of events 1 • Baseline through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Tooth decay
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.94%
1/106 • Number of events 1 • Baseline through 12 weeks
|
|
General disorders
Fever
|
33.3%
2/6 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
33.3%
2/6 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Irritability (frustration)
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Pain
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Infections and infestations
Oral Infection
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Infections and infestations
Sinusitis - sinus infection (incl. bacterial, fungal, viral)
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
40.0%
2/5 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Injury, poisoning and procedural complications
Sprained Ankle
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Gastrointestinal disorders
Appetite, Increase/hunger
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Endocrine disorders
Hypoglycemia (low blood sugar)
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle aches/pain/spasms)
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 4 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint aches)
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Exposed Jaw Bone
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Ear and labyrinth disorders
Dizziness/Lightheadedness
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 3 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Vascular disorders
Headache (incl. migraine)
|
16.7%
1/6 • Number of events 3 • Baseline through 12 weeks
|
28.6%
2/7 • Number of events 2 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 2 • Baseline through 12 weeks
|
33.3%
2/6 • Number of events 3 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
30.0%
3/10 • Number of events 4 • Baseline through 12 weeks
|
60.0%
3/5 • Number of events 3 • Baseline through 12 weeks
|
0.94%
1/106 • Number of events 1 • Baseline through 12 weeks
|
|
Vascular disorders
Intracranial Vascular Event (stroke/aneurysm)
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Nervous system disorders
Paresthesia (numbness/tingling)
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Sinus Pain
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
Anxiety, clinical diagnosis
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
Anxious (nervous) mood
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
Anxiety/Panic Attack
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
CES-D Score, elevated
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
28.6%
2/7 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
60.0%
3/5 • Number of events 5 • Baseline through 12 weeks
|
60.0%
3/5 • Number of events 3 • Baseline through 12 weeks
|
30.0%
3/10 • Number of events 4 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
5.7%
6/106 • Number of events 6 • Baseline through 12 weeks
|
|
Psychiatric disorders
Depressed (sad) mood
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
Insomnia (change/disturbance in sleep)
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
Nightmare/terror
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
Forgetfulness
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Renal and urinary disorders
Worsened Kidney Disease
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Immune system disorders
Allergic rhinitis (incl. seasonal allergies)
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Cough
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
33.3%
2/6 • Number of events 2 • Baseline through 12 weeks
|
66.7%
4/6 • Number of events 5 • Baseline through 12 weeks
|
60.0%
3/5 • Number of events 3 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
30.0%
3/10 • Number of events 3 • Baseline through 12 weeks
|
60.0%
3/5 • Number of events 3 • Baseline through 12 weeks
|
0.94%
1/106 • Number of events 1 • Baseline through 12 weeks
|
|
General disorders
Cough, Productive (lung 'fullness')
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
30.0%
3/10 • Number of events 3 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Nasal congestion (incl. runny nose)
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 2 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
50.0%
3/6 • Number of events 3 • Baseline through 12 weeks
|
40.0%
2/5 • Number of events 3 • Baseline through 12 weeks
|
40.0%
2/5 • Number of events 2 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 3 • Baseline through 12 weeks
|
60.0%
3/5 • Number of events 3 • Baseline through 12 weeks
|
0.94%
1/106 • Number of events 1 • Baseline through 12 weeks
|
|
General disorders
Nosebleed / Dry nasal membrane
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Immune system disorders
Postnasal Drip
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
40.0%
2/5 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.94%
1/106 • Number of events 1 • Baseline through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 2 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Hepatobiliary disorders
Sore throat (incl. itchy/irritated throat)
|
0.00%
0/6 • Baseline through 12 weeks
|
42.9%
3/7 • Number of events 4 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
33.3%
2/6 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 3 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
General disorders
Hyperhidrosis (excessive sweating)
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Psychiatric disorders
Stress
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
42.9%
3/7 • Number of events 6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
20.0%
2/10 • Number of events 2 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.94%
1/106 • Number of events 1 • Baseline through 12 weeks
|
|
Cardiac disorders
Hypertension (high BP)
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 3 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
5.7%
6/106 • Number of events 6 • Baseline through 12 weeks
|
|
Infections and infestations
methicillin-resistant Staphylococcus aureus
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Infections and infestations
vaginal infection
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Cut/Abrasion
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
20.0%
1/5 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
10.0%
1/10 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Injury, poisoning and procedural complications
torn hamstring tendon
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
stiffness thumb
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/7 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
16.7%
1/6 • Number of events 2 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
|
Renal and urinary disorders
elevated potassium (hyperkalemia)
|
0.00%
0/6 • Baseline through 12 weeks
|
14.3%
1/7 • Number of events 1 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/6 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/10 • Baseline through 12 weeks
|
0.00%
0/5 • Baseline through 12 weeks
|
0.00%
0/106 • Baseline through 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place