Trial Outcomes & Findings for Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes (NCT NCT03856515)
NCT ID: NCT03856515
Last Updated: 2026-01-28
Results Overview
Mean cigarettes per day (CPD) smoked during the phase
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
169 participants
Primary outcome timeframe
2 weeks
Results posted on
2026-01-28
Participant Flow
Participants were adult individuals residing in the state of Texas who completed the study remotely.
Of the 1363 potential participants who responded to study advertising, 702 were screened for interest and eligibility. Of those screened, 130 were ineligible and 402 declined to participate. A total of 169 participants were randomized.
Participant milestones
| Measure |
Phase 1: Usual Brand Cigarette Phase (Men)
Two weeks (Phase 1; weeks 1-2) of smoking usual brand cigarettes (men)
|
Phase 1: Usual Brand Cigarette Phase (Women)
Two weeks (Phase 1; weeks 1-2) of smoking usual brand cigarettes (women)
|
Phase 2 Placebo, Then Phase 3 Standardized Research Electronic Cigarette (SREC) (Men)
Two weeks (Phase 2; weeks 3-4) of placebo Standardized Research Electronic Cigarette use, followed by two weeks (Phase 3; weeks 5-6) of nicotine Standardized Research Electronic Cigarette use (Men)
|
Phase 2 Placebo, Then Phase 3 SREC (Women)
Two weeks (Phase 2; weeks 3-4) of placebo Standardized Research Electronic Cigarette use, followed by two weeks (Phase 3; weeks 5-6) of nicotine Standardized Research Electronic Cigarette use (Women)
|
Phase 2 SREC, Then Phase 3 Placebo (Men)
Two weeks (Phase 2; weeks 3-4) of nicotine Standardized Research Electronic Cigarette use, followed by two weeks (Phase 3; weeks 5-6) of placebo Standardized Research Electronic Cigarette use (Men)
|
Phase 2 SREC, Then Phase 3 Placebo (Women)
Two weeks (Phase 2; weeks 3-4) of nicotine Standardized Research Electronic Cigarette use, followed by two weeks (Phase 3; weeks 5-6) of placebo Standardized Research Electronic Cigarette use (Women)
|
|---|---|---|---|---|---|---|
|
Phase 1: Week 1-2
STARTED
|
87
|
82
|
0
|
0
|
0
|
0
|
|
Phase 1: Week 1-2
COMPLETED
|
87
|
82
|
0
|
0
|
0
|
0
|
|
Phase 1: Week 1-2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2: Week 3-4
STARTED
|
0
|
0
|
45
|
41
|
42
|
41
|
|
Phase 2: Week 3-4
COMPLETED
|
0
|
0
|
39
|
38
|
40
|
35
|
|
Phase 2: Week 3-4
NOT COMPLETED
|
0
|
0
|
6
|
3
|
2
|
6
|
|
Phase 3: Week 5-6
STARTED
|
0
|
0
|
45
|
41
|
42
|
41
|
|
Phase 3: Week 5-6
COMPLETED
|
0
|
0
|
36
|
37
|
38
|
32
|
|
Phase 3: Week 5-6
NOT COMPLETED
|
0
|
0
|
9
|
4
|
4
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes
Baseline characteristics by cohort
| Measure |
Phase 1: Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes followed by two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (SREC) and the two weeks of using the Nicotine (5% nicotine content) SREC, with SREC order counterbalanced.
|
Phase 1: Usual Brand Cigarette Phase (Women)
n=82 Participants
Two weeks of smoking usual brand cigarettes followed by two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (SREC) and the two weeks of using the Nicotine (5% nicotine content) SREC, with SREC order counterbalanced.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.51 years
STANDARD_DEVIATION 11.26 • n=158 Participants
|
44.57 years
STANDARD_DEVIATION 10.14 • n=157 Participants
|
44.54 years
STANDARD_DEVIATION 10.72 • n=315 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=158 Participants
|
82 Participants
n=157 Participants
|
82 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
87 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=158 Participants
|
7 Participants
n=157 Participants
|
22 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=158 Participants
|
75 Participants
n=157 Participants
|
147 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=158 Participants
|
23 Participants
n=157 Participants
|
44 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=158 Participants
|
55 Participants
n=157 Participants
|
102 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
9 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
10 Participants
n=315 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=158 Participants
|
82 participants
n=157 Participants
|
169 participants
n=315 Participants
|
PRIMARY outcome
Timeframe: 2 weeksMean cigarettes per day (CPD) smoked during the phase
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=83 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=81 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=76 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=79 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Cigarettes Per Day
|
14.20 Cigarettes per Day
Standard Deviation 9.01
|
4.08 Cigarettes per Day
Standard Deviation 6.31
|
4.55 Cigarettes per Day
Standard Deviation 7.25
|
14.09 Cigarettes per Day
Standard Deviation 7.66
|
3.85 Cigarettes per Day
Standard Deviation 5.30
|
3.63 Cigarettes per Day
Standard Deviation 4.72
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Electronic cigarette sessions per day were not assessed during the Usual Brand Cigarette phase.
Study electronic cigarette use measured by the mean number of sessions per day during each phase for male and female participants.
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=83 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=81 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=76 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=79 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Electronic Cigarette Sessions Per Day
|
—
|
11.32 Sessions per day
Standard Deviation 9.49
|
10.33 Sessions per day
Standard Deviation 8.93
|
—
|
10.78 Sessions per day
Standard Deviation 9.28
|
10.84 Sessions per day
Standard Deviation 10.84
|
SECONDARY outcome
Timeframe: 2 weeksA measure of nicotine exposure, calculated as the sum of total nicotine, cotinine, 3'-hydroxycotinine, and nicotine N-oxide excreted in urine, collected at the end of each phase for male and female participants.
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=73 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=73 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=77 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=66 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=69 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Total Nicotine Equivalents (TNE)
|
42.01 ng/mL
Standard Deviation 37.40
|
30.98 ng/mL
Standard Deviation 30.12
|
39.97 ng/mL
Standard Deviation 36.44
|
41.19 ng/mL
Standard Deviation 33.44
|
39.46 ng/mL
Standard Deviation 38.80
|
41.75 ng/mL
Standard Deviation 42.11
|
SECONDARY outcome
Timeframe: 2 weeksA tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=73 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=73 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=77 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=66 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=69 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Anabasine
|
92.69 ng/mL
Standard Deviation 155.35
|
56.60 ng/mL
Standard Deviation 97.03
|
71.45 ng/mL
Standard Deviation 98.16
|
76.19 ng/mL
Standard Deviation 92.95
|
72.90 ng/mL
Standard Deviation 107.13
|
65.61 ng/mL
Standard Deviation 83.24
|
SECONDARY outcome
Timeframe: 2 weeksA tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=73 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=73 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=77 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=66 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=69 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Nicotelline
|
0.64 ng/mL
Standard Error 4.53
|
0.38 ng/mL
Standard Error 2.05
|
0.42 ng/mL
Standard Error 2.92
|
1.63 ng/mL
Standard Error 7.98
|
2.22 ng/mL
Standard Error 8.42
|
1.08 ng/mL
Standard Error 3.73
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of participants' beliefs about their risks of developing health conditions from cigarettes or electronic cigarette collected at the end of each phase for male and female participants. Range 1-10, with higher values indicating greater perceived risk of negative health outcomes.
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=82 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=75 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Perceived Health Risk Questionnaire (PHRQ)
|
8.15 Units on a scale
Standard Deviation 2.18
|
8.35 Units on a scale
Standard Deviation 2.22
|
8.43 Units on a scale
Standard Deviation 2.06
|
9.05 Units on a scale
Standard Deviation 1.99
|
9.21 Units on a scale
Standard Deviation 1.79
|
9.23 Units on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of explicit cigarette or electronic cigarette product liking collected at the end of each phase for male and female participants. Range 1-7, with higher values indicating more unpleasant ratings.
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=78 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=67 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=67 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=69 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Product Evaluation Scales (PES)
|
4.33 Units on a scale
Standard Deviation 0.98
|
3.30 Units on a scale
Standard Deviation 0.98
|
3.44 Units on a scale
Standard Deviation 1.04
|
4.51 Units on a scale
Standard Deviation 1.12
|
3.42 Units on a scale
Standard Deviation 1.17
|
3.73 Units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of implicit cigarette or electronic cigarette liking collected at the end of each phase for male and female participants. Range: -1 to 1, with more negative values indicating a more negative attitude toward the cigarette product
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=86 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=79 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=69 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=76 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=65 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Implicit Association Test (IAT)
|
-0.29 Units on a scale
Standard Deviation 0.53
|
-0.17 Units on a scale
Standard Deviation 0.48
|
-0.08 Units on a scale
Standard Deviation 0.50
|
-0.32 Units on a scale
Standard Deviation 0.62
|
-0.15 Units on a scale
Standard Deviation 0.40
|
-0.25 Units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of the perceived outcomes of cigarette or electronic cigarette use collected at the end of each phase for male and female participants. Range 0 to 9, with larger values indicating greater perceived negative consequences of cigarette use
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=82 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=75 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Brief Smoking Consequences Questionnaire-Adult (BSCQ-A)
|
4.56 Units on a scale
Standard Deviation 1.22
|
3.68 Units on a scale
Standard Deviation 1.25
|
3.54 Units on a scale
Standard Deviation 1.34
|
4.61 Units on a scale
Standard Deviation 1.25
|
3.70 Units on a scale
Standard Deviation 1.70
|
3.72 Units on a scale
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of the Purchase Task Breakpoint measure (first price at which consumption goes to zero, i.e., unwilling to pay) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.05 - 251, dollars per cigarette or per electronic cigarette puff with higher values indicating the willingness to smoke/vape at a higher price.
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=64 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=61 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=76 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=53 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=59 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Purchase Task Breakpoint Measure
|
13.67 $/cigarette or $/e-cigarette puff
Standard Deviation 22.12
|
7.06 $/cigarette or $/e-cigarette puff
Standard Deviation 16.97
|
4.65 $/cigarette or $/e-cigarette puff
Standard Deviation 9.69
|
14.25 $/cigarette or $/e-cigarette puff
Standard Deviation 33.22
|
5.73 $/cigarette or $/e-cigarette puff
Standard Deviation 10.64
|
7.44 $/cigarette or $/e-cigarette puff
Standard Deviation 16.92
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of the Purchase Task Demand Intensity measure (consumption at the lowest price) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 1 - 351, the number of cigarettes or electronic cigarette puffs with higher values indicating an intension to smoke/vape more when the price is set as 0
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=64 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=61 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=77 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=53 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=59 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Purchase Task Demand Intensity Measure
|
20.52 # of cigarettes or e-cigarette puffs
Standard Deviation 14.37
|
70.05 # of cigarettes or e-cigarette puffs
Standard Deviation 69.59
|
59.08 # of cigarettes or e-cigarette puffs
Standard Deviation 51.94
|
19.05 # of cigarettes or e-cigarette puffs
Standard Deviation 13.14
|
48.06 # of cigarettes or e-cigarette puffs
Standard Deviation 43.06
|
60.39 # of cigarettes or e-cigarette puffs
Standard Deviation 56.06
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of the Purchase Task Omax measure (maximum financial expenditure on the product) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.03 - 1001, the maximum expenditure in dollars on cigarettes or electronic cigarette puffs with higher values indicating greater expenditure
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=64 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=61 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=77 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=53 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=59 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Purchase Task Omax Measure
|
17.96 max spent $ on cigarettes or e-cig puffs
Standard Deviation 22.51
|
24.74 max spent $ on cigarettes or e-cig puffs
Standard Deviation 72.92
|
11.73 max spent $ on cigarettes or e-cig puffs
Standard Deviation 13.09
|
35.40 max spent $ on cigarettes or e-cig puffs
Standard Deviation 127.18
|
13.51 max spent $ on cigarettes or e-cig puffs
Standard Deviation 23.20
|
19.94 max spent $ on cigarettes or e-cig puffs
Standard Deviation 65.14
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of the Purchase Task Pmax measure (price at which expenditure is maximized) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.01 - 1001, the price of the cigarette or electronic cigarette puffs when the Omax is reached
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=64 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=61 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=77 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=53 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=59 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Purchase Task Pmax Measure
|
4.64 US Dollars per cigarette or per electron
Standard Deviation 7.82
|
2.86 US Dollars per cigarette or per electron
Standard Deviation 7.97
|
1.65 US Dollars per cigarette or per electron
Standard Deviation 3.53
|
17.93 US Dollars per cigarette or per electron
Standard Deviation 114.14
|
2.36 US Dollars per cigarette or per electron
Standard Deviation 5.01
|
3.39 US Dollars per cigarette or per electron
Standard Deviation 8.39
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of the Purchase Task Elasticity of Demand measure (sensitivity of product consumption to increases in cost) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.0001 - 2.69, the elasticity of the demand for cigarettes or electronic cigarette puffs, with higher values indicating a greater sensitivity in reducing the consumption in response to the price increases
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=82 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=64 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=61 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=77 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=53 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=59 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Purchase Task Elasticity of Demand Measure
|
0.0070 % change quantity/% change price
Standard Deviation 0.0040
|
0.0130 % change quantity/% change price
Standard Deviation 0.0057
|
0.0177 % change quantity/% change price
Standard Deviation 0.0068
|
0.008 % change quantity/% change price
Standard Deviation 0.0040
|
0.026 % change quantity/% change price
Standard Deviation 0.009
|
0.0298 % change quantity/% change price
Standard Deviation 0.009
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 10, with higher values indicating greater cigarette dependence
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=82 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=74 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Fagerström Test for Cigarette Dependence (FTCD)
|
4.54 Units on a scale
Standard Deviation 2.09
|
3.71 Units on a scale
Standard Deviation 2.05
|
3.67 Units on a scale
Standard Deviation 2.07
|
4.7 Units on a scale
Standard Deviation 2.02
|
3.97 Units on a scale
Standard Deviation 2.28
|
3.88 Units on a scale
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The PSECDI questionnaire was not administered during the Usual Brand Cigarette phase.
Evaluation of electronic cigarette dependence collected at the end of each phase for male and female participants. Range 0 to 20, with higher scores indicating greater electronic cigarette dependence
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=78 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=67 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=67 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=69 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Penn State Electronic Cigarette Dependence Index (PSECDI)
|
—
|
7.78 Units on a scale
Standard Deviation 4.08
|
7.75 Units on a scale
Standard Deviation 3.97
|
—
|
8.87 Units on a scale
Standard Deviation 4.32
|
8.99 Units on a scale
Standard Deviation 4.36
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of nicotine withdrawal symptoms collected at the end of each phase for male and female participants. Range 0 to 60, with higher scores indicating greater nicotine withdrawal
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=82 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=75 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Minnesota Nicotine Withdrawal Scale-Revised (MNWS)
|
27.01 Units on a scale
Standard Deviation 7.98
|
27.02 Units on a scale
Standard Deviation 7.99
|
26.04 Units on a scale
Standard Deviation 7.62
|
28.81 Units on a scale
Standard Deviation 9.09
|
29.77 Units on a scale
Standard Deviation 9.77
|
28.08 Units on a scale
Standard Deviation 7.99
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of the craving to smoke cigarettes collected at the end of each phase for male and female participants. Range 1 to 10, with higher values indicating greater urge to smoke
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=82 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=75 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Questionnaire of Smoking Urges-Brief (QSU-Brief)
|
4.16 Units on a scale
Standard Deviation 2.57
|
3.35 Units on a scale
Standard Deviation 2.71
|
3.26 Units on a scale
Standard Deviation 2.83
|
4.25 Units on a scale
Standard Deviation 2.92
|
3.43 Units on a scale
Standard Deviation 3.04
|
2.80 Units on a scale
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of positive affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater positive affect
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=83 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=74 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos)
|
32.30 Units on a scale
Standard Deviation 8.56
|
31.12 Units on a scale
Standard Deviation 9.25
|
32.82 Units on a scale
Standard Deviation 9.69
|
32.80 Units on a scale
Standard Deviation 9.40
|
31.65 Units on a scale
Standard Deviation 9.09
|
33.03 Units on a scale
Standard Deviation 8.76
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of negative affect collected at the end of each phase for male and female participants. Range 10 to 50, with higher scores indicating greater negative affect
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=83 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=74 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg)
|
16.43 Units on a scale
Standard Deviation 7.31
|
16.22 Units on a scale
Standard Deviation 6.94
|
15.53 Units on a scale
Standard Deviation 6.89
|
17.19 Units on a scale
Standard Deviation 7.09
|
17.73 Units on a scale
Standard Deviation 8.06
|
16.07 Units on a scale
Standard Deviation 6.30
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of mean nicotine dependence symptoms collected daily during each phase. Range 1 to 5, with higher values indicating greater nicotine dependence symptoms
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=83 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=83 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=78 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=75 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=74 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
Smartphone Daily Measures of Nicotine Dependence Symptoms
|
2.40 Units on a scale
Standard Deviation 0.35
|
2.42 Units on a scale
Standard Deviation 0.48
|
2.34 Units on a scale
Standard Deviation 0.42
|
2.44 Units on a scale
Standard Deviation 0.33
|
2.53 Units on a scale
Standard Deviation 0.37
|
2.42 Units on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: 2 weeksEvaluation of respiratory symptoms collected at the end of each phase for male and female participants. Range 8 to 40, with higher numbers indicating more respiratory symptoms
Outcome measures
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 Participants
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=82 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=76 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=81 Participants
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=71 Participants
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=75 Participants
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
American Thoracic Society Questionnaire (ATSQ)
|
18.30 Units on a scale
Standard Deviation 8.98
|
16.85 Units on a scale
Standard Deviation 8.86
|
16.93 Units on a scale
Standard Deviation 8.59
|
18.17 Units on a scale
Standard Deviation 8.59
|
16.13 Units on a scale
Standard Deviation 7.96
|
16.08 Units on a scale
Standard Deviation 7.96
|
Adverse Events
Usual Brand Cigarette Phase (Men)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Standardized Research Electronic Cigarette Phase (Men)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Nicotine Standardized Research Electronic Cigarette Phase (Men)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Brand Cigarette Phase (Women)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Standardized Research Electronic Cigarette Phase (Women)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Nicotine Standardized Research Electronic Cigarette Phase (Women)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Brand Cigarette Phase (Men)
n=87 participants at risk
Two weeks of smoking usual brand cigarettes (Men)
|
Placebo Standardized Research Electronic Cigarette Phase (Men)
n=87 participants at risk
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Nicotine Standardized Research Electronic Cigarette Phase (Men)
n=87 participants at risk
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Men)
|
Usual Brand Cigarette Phase (Women)
n=82 participants at risk
Two weeks of smoking usual brand cigarettes (Women)
|
Placebo Standardized Research Electronic Cigarette Phase (Women)
n=82 participants at risk
Two weeks of using the Placebo (0% nicotine content) Standardized Research Electronic Cigarette (Women)
|
Nicotine Standardized Research Electronic Cigarette Phase (Women)
n=82 participants at risk
Two weeks of using the Nicotine (5% nicotine content) Standardized Research Electronic Cigarette (Women)
|
|---|---|---|---|---|---|---|
|
General disorders
Flu Like Symptoms
|
0.00%
0/87 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
1.2%
1/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
0.00%
0/87 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
|
Nervous system disorders
Psychosis
|
0.00%
0/87 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
1.2%
1/82 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/87 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
1.2%
1/82 • 10 weeks
|
1.2%
1/82 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/87 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/87 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
0.00%
0/82 • 10 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place