Trial Outcomes & Findings for Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it (NCT NCT03953183)
NCT ID: NCT03953183
Last Updated: 2020-12-14
Results Overview
To measure the plasma nicotine concentration-time profile following correction of baseline nicotine levels.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
Results posted on
2020-12-14
Participant Flow
Participant milestones
| Measure |
P3P-1mg
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
P3P-1mg
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it
Baseline characteristics by cohort
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=30 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 4.82 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 8.36 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
174 cm
STANDARD_DEVIATION 9.49 • n=5 Participants
|
172 cm
STANDARD_DEVIATION 12.5 • n=7 Participants
|
173 cm
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
BMI
|
23.3 kg/m^2
STANDARD_DEVIATION 3.69 • n=5 Participants
|
24.0 kg/m^2
STANDARD_DEVIATION 3.48 • n=7 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 3.58 • n=5 Participants
|
PRIMARY outcome
Timeframe: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.Population: Some participants were excluded from analysis for protocol deviations. For participants in whom the elimination rate constant could not be calculated for any of the visits, background-corrected nicotine concentrations were considered as missing.
To measure the plasma nicotine concentration-time profile following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=28 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Plasma Nicotine Concentration-time Profile
4 mins after start of product use (Day 1)
|
0.563 ng/ml
Interval 0.384 to 0.824
|
0.563 ng/ml
Interval 0.37 to 0.858
|
|
Plasma Nicotine Concentration-time Profile
7 mins after start of product use (Day 1)
|
0.928 ng/ml
Interval 0.635 to 1.36
|
1.02 ng/ml
Interval 0.688 to 1.51
|
|
Plasma Nicotine Concentration-time Profile
10 mins after start of product use (Day 1)
|
0.982 ng/ml
Interval 0.699 to 1.38
|
1.39 ng/ml
Interval 0.949 to 2.03
|
|
Plasma Nicotine Concentration-time Profile
15 mins after start of product use (Day 1)
|
1.18 ng/ml
Interval 0.914 to 1.54
|
1.58 ng/ml
Interval 1.14 to 2.2
|
|
Plasma Nicotine Concentration-time Profile
30 mins after start of product use (Day 1)
|
1.24 ng/ml
Interval 0.969 to 1.6
|
1.59 ng/ml
Interval 1.09 to 2.34
|
|
Plasma Nicotine Concentration-time Profile
1 hr after start of product use (Day 1)
|
1.07 ng/ml
Interval 0.85 to 1.34
|
1.45 ng/ml
Interval 1.04 to 2.02
|
|
Plasma Nicotine Concentration-time Profile
2 hr after start of product use (Day 1)
|
0.702 ng/ml
Interval 0.546 to 0.904
|
1.08 ng/ml
Interval 0.824 to 1.41
|
|
Plasma Nicotine Concentration-time Profile
4 hr after start of product use (Day 1)
|
0.353 ng/ml
Interval 0.272 to 0.458
|
0.570 ng/ml
Interval 0.416 to 0.781
|
|
Plasma Nicotine Concentration-time Profile
4 mins after start of product use (Day 30)
|
1.01 ng/ml
Interval 0.784 to 1.31
|
0.990 ng/ml
Interval 0.621 to 1.58
|
|
Plasma Nicotine Concentration-time Profile
7 mins after start of product use (Day 30)
|
1.28 ng/ml
Interval 0.985 to 1.66
|
1.34 ng/ml
Interval 0.866 to 2.08
|
|
Plasma Nicotine Concentration-time Profile
10 mins after start of product use (Day 30)
|
1.46 ng/ml
Interval 1.19 to 1.78
|
1.62 ng/ml
Interval 1.13 to 2.31
|
|
Plasma Nicotine Concentration-time Profile
15 mins after start of product use (Day 30)
|
1.45 ng/ml
Interval 1.21 to 1.75
|
1.67 ng/ml
Interval 1.13 to 2.46
|
|
Plasma Nicotine Concentration-time Profile
30 mins after start of product use (Day 30)
|
1.29 ng/ml
Interval 1.01 to 1.65
|
1.76 ng/ml
Interval 1.21 to 2.56
|
|
Plasma Nicotine Concentration-time Profile
1 hr after start of product use (Day 30)
|
1.16 ng/ml
Interval 1.01 to 1.33
|
1.71 ng/ml
Interval 1.29 to 2.26
|
|
Plasma Nicotine Concentration-time Profile
2 hr after start of product use (Day 30)
|
0.927 ng/ml
Interval 0.726 to 1.18
|
1.16 ng/ml
Interval 0.784 to 1.72
|
|
Plasma Nicotine Concentration-time Profile
4 hr after start of product use (Day 30)
|
0.530 ng/ml
Interval 0.36 to 0.782
|
0.551 ng/ml
Interval 0.361 to 0.84
|
PRIMARY outcome
Timeframe: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.To measure the maximum plasma nicotine concentration \[cCmax\] following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=28 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Maximum Nicotine Concentration [cCmax]
Day 1
|
1.46 ng/mL
Interval 1.12 to 1.89
|
2.11 ng/mL
Interval 1.62 to 2.75
|
|
Maximum Nicotine Concentration [cCmax]
Day 30
|
2.05 ng/mL
Interval 1.69 to 2.48
|
2.39 ng/mL
Interval 1.73 to 3.32
|
PRIMARY outcome
Timeframe: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.To measure the time to maximum nicotine concentration \[cTmax\] following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=28 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Time to the Maximum Nicotine Concentration [cTmax]
Day 1
|
30.0 minutes
Interval 15.0 to 30.0
|
30.0 minutes
Interval 15.0 to 30.0
|
|
Time to the Maximum Nicotine Concentration [cTmax]
Day 30
|
15.0 minutes
Interval 10.0 to 30.0
|
30.0 minutes
Interval 15.0 to 60.0
|
PRIMARY outcome
Timeframe: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.Population: Some participants were excluded from analysis for protocol deviations. For participants in whom the elimination rate constant could not be calculated for any of the visits, background-corrected nicotine concentrations were considered as missing.
To measure the area under the plasma concentration-time curve \[cAUC(0-4h)\] following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=28 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)]
Day 1
|
3.03 ng*hour/mL
Interval 2.34 to 3.92
|
4.74 ng*hour/mL
Interval 3.64 to 6.19
|
|
Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)]
Day 30
|
3.96 ng*hour/mL
Interval 3.29 to 4.78
|
5.35 ng*hour/mL
Interval 3.85 to 7.43
|
SECONDARY outcome
Timeframe: Before, during and up to 4 hours post-product use on day 1 and day 30Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving). Over time results calculated as area under curve mm\*hour.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=28 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Craving for a Cigarette
Day 1
|
138 score on a scale (millimetres*hour)
Interval 111.0 to 166.0
|
111 score on a scale (millimetres*hour)
Interval 73.2 to 149.0
|
|
Craving for a Cigarette
Day 30
|
130 score on a scale (millimetres*hour)
Interval 99.1 to 160.0
|
109 score on a scale (millimetres*hour)
Interval 68.6 to 149.0
|
SECONDARY outcome
Timeframe: Within 60 minutes after product use on day 1 and day 30.Measured with a Sensory Questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Sensory Parameters
Puffs Evaluation/Liking (day 1)
|
3.33 score on a scale
Interval 2.82 to 3.85
|
3.50 score on a scale
Interval 2.87 to 4.13
|
|
Sensory Parameters
Puffs Harshness (day 1)
|
4.60 score on a scale
Interval 4.09 to 5.11
|
5.18 score on a scale
Interval 4.74 to 5.61
|
|
Sensory Parameters
Puffs Similar to Own Brand (day 1)
|
2.33 score on a scale
Interval 1.77 to 2.9
|
3.04 score on a scale
Interval 2.24 to 3.83
|
|
Sensory Parameters
Puffs Strength on Tongue (day 1)
|
3.00 score on a scale
Interval 2.47 to 3.53
|
3.57 score on a scale
Interval 2.94 to 4.2
|
|
Sensory Parameters
Puffs Strength in Nose (day 1)
|
1.80 score on a scale
Interval 1.4 to 2.2
|
2.07 score on a scale
Interval 1.71 to 2.44
|
|
Sensory Parameters
Puffs Strength in Back of Mouth/Throat (day 1)
|
4.83 score on a scale
Interval 4.3 to 5.36
|
5.07 score on a scale
Interval 4.6 to 5.54
|
|
Sensory Parameters
Puff Strength in Windpipe (day 1)
|
4.50 score on a scale
Interval 3.89 to 5.11
|
4.89 score on a scale
Interval 4.44 to 5.34
|
|
Sensory Parameters
Puff Strength in Chest (day 1)
|
3.40 score on a scale
Interval 2.78 to 4.02
|
3.86 score on a scale
Interval 3.25 to 4.46
|
|
Sensory Parameters
Puffs Evaluation/Liking (day 30)
|
3.43 score on a scale
Interval 2.97 to 3.9
|
3.46 score on a scale
Interval 2.78 to 4.15
|
|
Sensory Parameters
Puffs Harshness (day 30)
|
4.20 score on a scale
Interval 3.67 to 4.73
|
4.68 score on a scale
Interval 4.15 to 5.21
|
|
Sensory Parameters
Puffs Similar to Own Brand (day 30)
|
2.93 score on a scale
Interval 2.25 to 3.61
|
2.64 score on a scale
Interval 2.04 to 3.24
|
|
Sensory Parameters
Puffs Strength on Tongue (day 30)
|
2.83 score on a scale
Interval 2.26 to 3.41
|
3.36 score on a scale
Interval 2.88 to 3.83
|
|
Sensory Parameters
Puffs Strength in Nose (day 30)
|
1.80 score on a scale
Interval 1.43 to 2.17
|
1.93 score on a scale
Interval 1.55 to 2.31
|
|
Sensory Parameters
Puffs Strength in Back of Mouth/Throat (day 30)
|
4.87 score on a scale
Interval 4.31 to 5.43
|
4.86 score on a scale
Interval 4.35 to 5.36
|
|
Sensory Parameters
Puff Strength in Windpipe (day 30)
|
4.20 score on a scale
Interval 3.54 to 4.86
|
4.93 score on a scale
Interval 4.45 to 5.41
|
|
Sensory Parameters
Puff Strength in Chest (day 30)
|
3.53 score on a scale
Interval 2.89 to 4.17
|
4.07 score on a scale
Interval 3.61 to 4.53
|
SECONDARY outcome
Timeframe: Within 60 minutes after product use on day 1 and day 30.Measured with ABOUT\[TM\]-Product Experience questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Product Experience
Aversion (day 1)
|
1.25 score
Interval 1.08 to 1.42
|
1.32 score
Interval 1.12 to 1.53
|
|
Product Experience
Aversion (day 30)
|
1.35 score
Interval 1.1 to 1.6
|
1.45 score
Interval 1.1 to 1.79
|
|
Product Experience
Craving reduction (day 1)
|
4.23 score
Interval 3.65 to 4.82
|
4.04 score
Interval 3.38 to 4.69
|
|
Product Experience
Craving reduction (day 30)
|
4.07 score
Interval 3.47 to 4.66
|
4.14 score
Interval 3.56 to 4.73
|
|
Product Experience
Psychological reward (day 1)
|
3.00 score
Interval 2.61 to 3.39
|
3.16 score
Interval 2.66 to 3.65
|
|
Product Experience
Psychological reward (day 30)
|
3.11 score
Interval 2.72 to 3.49
|
2.93 score
Interval 2.47 to 3.39
|
|
Product Experience
Enjoyment of respiratory tract sensations (day 1)
|
2.13 score
Interval 1.58 to 2.69
|
2.29 score
Interval 1.65 to 2.92
|
|
Product Experience
Enjoyment of respiratory tract sensations (day 30)
|
2.33 score
Interval 1.81 to 2.86
|
2.29 score
Interval 1.7 to 2.87
|
|
Product Experience
Product satisfaction (day 1)
|
3.70 score
Interval 3.26 to 4.14
|
3.62 score
Interval 3.1 to 4.14
|
|
Product Experience
Product satisfaction (day 30)
|
3.50 score
Interval 3.06 to 3.94
|
3.42 score
Interval 2.86 to 3.98
|
SECONDARY outcome
Timeframe: Within 60 minutes after product use on day 1 and day 30.Measured with ABOUT\[TM\]-Dependence questionnaire. Response to each question is assessed on a 5-point scale, ranging from 1 (not at all/never) to 5 (extremely/all the time) or a 6-point scale ranging from 0 (more than 3 hours) to 5 (0-5 minutes).
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Product Dependence
Extent of use (day 1)
|
57.9 score
Interval 52.3 to 63.5
|
59.1 score
Interval 52.9 to 65.2
|
|
Product Dependence
Extent of use (day 30)
|
52.8 score
Interval 47.2 to 58.5
|
53.0 score
Interval 47.4 to 58.6
|
|
Product Dependence
Signs and symptoms (day 1)
|
45.2 score
Interval 42.1 to 48.4
|
49.5 score
Interval 45.7 to 53.3
|
|
Product Dependence
Signs and symptoms (day 30)
|
38.3 score
Interval 33.7 to 43.0
|
41.1 score
Interval 37.4 to 44.8
|
|
Product Dependence
Behavioral impact (day 1)
|
32.3 score
Interval 28.6 to 36.0
|
35.7 score
Interval 30.2 to 41.2
|
|
Product Dependence
Behavioral impact (day 30)
|
23.5 score
Interval 17.5 to 29.5
|
26.8 score
Interval 20.9 to 32.6
|
SECONDARY outcome
Timeframe: Within 60 minutes after product use on day 1 and day 30.Measured with a Product Acceptance questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (most negative) to 7 (most positive) or as multiple choice questions.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Product Acceptance
Overall opinion about P3P (day 1)
|
3.63 score on a scale
Interval 3.1 to 4.17
|
3.46 score on a scale
Interval 2.94 to 3.99
|
|
Product Acceptance
Overall opinion about P3P (day 30)
|
3.80 score on a scale
Interval 3.33 to 4.27
|
3.61 score on a scale
Interval 2.88 to 4.33
|
|
Product Acceptance
Taste intensity (day 1)
|
5.27 score on a scale
Interval 4.65 to 5.88
|
5.36 score on a scale
Interval 4.79 to 5.93
|
|
Product Acceptance
Taste intensity (day 30)
|
5.03 score on a scale
Interval 4.36 to 5.7
|
5.25 score on a scale
Interval 4.52 to 5.98
|
|
Product Acceptance
Consistency of sensation (day 1)
|
4.23 score on a scale
Interval 3.81 to 4.66
|
3.93 score on a scale
Interval 3.45 to 4.41
|
|
Product Acceptance
Consistency of sensation (day 30)
|
3.93 score on a scale
Interval 3.35 to 4.51
|
4.29 score on a scale
Interval 3.78 to 4.79
|
|
Product Acceptance
Compared to pipe (day 1)
|
4.00 score on a scale
Interval 2.99 to 5.01
|
3.25 score on a scale
Interval 2.1 to 4.4
|
|
Product Acceptance
Compared to pipe (day 30)
|
3.77 score on a scale
Interval 3.06 to 4.47
|
3.90 score on a scale
Interval 2.71 to 5.09
|
|
Product Acceptance
Compared to hookah (day 1)
|
3.28 score on a scale
Interval 2.54 to 4.02
|
3.24 score on a scale
Interval 2.36 to 4.11
|
|
Product Acceptance
Compared to hookah (day 30)
|
3.40 score on a scale
Interval 2.51 to 4.29
|
2.88 score on a scale
Interval 1.84 to 3.92
|
|
Product Acceptance
Compared to heat-not-burn (day 1)
|
3.27 score on a scale
Interval 2.21 to 4.33
|
3.19 score on a scale
Interval 1.92 to 4.45
|
|
Product Acceptance
Compared to heat-not-burn (day 30)
|
3.06 score on a scale
Interval 2.06 to 4.06
|
4.13 score on a scale
Interval 2.99 to 5.28
|
|
Product Acceptance
Compared to e-cigarette (day 1)
|
4.17 score on a scale
Interval 3.21 to 5.12
|
3.76 score on a scale
Interval 2.58 to 4.95
|
|
Product Acceptance
Compared to e-cigarette (day 30)
|
3.71 score on a scale
Interval 3.03 to 4.38
|
3.07 score on a scale
Interval 2.07 to 4.07
|
|
Product Acceptance
Compared to snuff/chewing tobacco (day 1)
|
5.00 score on a scale
Interval 3.12 to 6.88
|
5.00 score on a scale
Interval 2.09 to 7.91
|
|
Product Acceptance
Compared to snuff/chewing tobacco (day 30)
|
3.56 score on a scale
Interval 2.01 to 5.1
|
4.83 score on a scale
Interval 2.59 to 7.08
|
|
Product Acceptance
Compared to NRT (day 1)
|
6.40 score on a scale
Interval 5.29 to 7.51
|
5.67 score on a scale
Interval 3.21 to 8.12
|
|
Product Acceptance
Compared to NRT (day 30)
|
4.86 score on a scale
Interval 3.31 to 6.41
|
4.20 score on a scale
Interval 1.51 to 6.89
|
SECONDARY outcome
Timeframe: Evaluated by site staff on day 1 and day 30. Self-evaluated by subject on day 2, day 7, day 15, day 22, and day 29.To measure changes in subject puffing behavior. Evaluated by selection of one puffing behavior response out of three possible responses. * 1\. Puffing and holding the aerosol in the mouth for a short time and then inhaling (i.e. like a cigarette) * 2\. Puffing and immediately inhaling (without holding the aerosol in the mouth) * 3\. Puffing and immediately exhaling, without inhalation
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Puffing Behavior of Subject
Day 2: Inhalation Behavior #1
|
18 Participants
|
17 Participants
|
|
Puffing Behavior of Subject
Day 2: Behavior #2
|
12 Participants
|
11 Participants
|
|
Puffing Behavior of Subject
Day 2: Behavior #3
|
0 Participants
|
0 Participants
|
|
Puffing Behavior of Subject
Day 29: Behavior #1
|
20 Participants
|
21 Participants
|
|
Puffing Behavior of Subject
Day 29: Behavior #2
|
10 Participants
|
7 Participants
|
|
Puffing Behavior of Subject
Day 29: Behavior #3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Recorded daily by subject, in product use diary, from day 1 until day 30.To assess the number of any nicotine/tobacco products used overall on a daily basis.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=30 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Overall Product Use
Cigarettes
|
2.64 products used per day
Interval 2.17 to 3.5
|
2.68 products used per day
Interval 1.84 to 3.52
|
|
Overall Product Use
P3P
|
6.54 products used per day
Interval 6.06 to 7.02
|
6.37 products used per day
Interval 5.54 to 7.21
|
|
Overall Product Use
Heat not burn and/or smokeless tobacco
|
0.26 products used per day
Interval -0.09 to 0.61
|
0.25 products used per day
Interval -0.11 to 0.62
|
|
Overall Product Use
Other tobacco products
|
0.02 products used per day
Interval -0.02 to 0.06
|
0.01 products used per day
Interval -0.01 to 0.03
|
|
Overall Product Use
Electronic cigarettes
|
0.00 products used per day
Interval 0.0 to 0.01
|
0.02 products used per day
Interval -0.01 to 0.05
|
SECONDARY outcome
Timeframe: Measured at baseline, day 7, day 15, day 22, and day 29.Population: Some participants were excluded from analysis for protocol deviations.
To measure percent changes from baseline in Nicotine equivalents (NEQ) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
NEQ
Day 7
|
20.3 Percent change from baseline
Interval -11.5 to 52.1
|
30.1 Percent change from baseline
Interval -16.7 to 76.8
|
|
NEQ
Day 15
|
44.6 Percent change from baseline
Interval -13.7 to 103.0
|
30.4 Percent change from baseline
Interval 0.0291 to 60.8
|
|
NEQ
Day 22
|
41.7 Percent change from baseline
Interval -16.0 to 99.3
|
18.8 Percent change from baseline
Interval -1.89 to 39.5
|
|
NEQ
Day 29
|
26.4 Percent change from baseline
Interval -12.4 to 65.1
|
22.9 Percent change from baseline
Interval -11.7 to 57.4
|
SECONDARY outcome
Timeframe: Measured at baseline, day 7, day 15, day 22, and day 29.Population: Some participants were excluded from analysis for protocol deviations.
To measure percent changes from baseline in total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Total NNAL
Day 7
|
-7.07 Percent change from baseline
Interval -46.9 to 32.8
|
-17.1 Percent change from baseline
Interval -36.3 to 2.05
|
|
Total NNAL
Day 15
|
-8.05 Percent change from baseline
Interval -39.1 to 23.0
|
-5.75 Percent change from baseline
Interval -28.5 to 17.0
|
|
Total NNAL
Day 22
|
14.3 Percent change from baseline
Interval -27.9 to 56.4
|
-14.4 Percent change from baseline
Interval -33.6 to 4.75
|
|
Total NNAL
Day 29
|
-6.10 Percent change from baseline
Interval -29.6 to 17.4
|
-11.8 Percent change from baseline
Interval -36.2 to 12.6
|
SECONDARY outcome
Timeframe: Measured at baseline, day 7, day 15, day 22, and day 29.Population: Some participants were excluded from analysis for protocol deviations.
To measure percent changes from baseline in 2-cyanoethylmercapturic acid (CEMA) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine (ng/mg creat).
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
CEMA
Day 7
|
-41.1 Percent change from baseline
Interval -57.2 to -18.8
|
-27.3 Percent change from baseline
Interval -44.4 to -4.99
|
|
CEMA
Day 15
|
-38.5 Percent change from baseline
Interval -55.7 to -14.5
|
-26.0 Percent change from baseline
Interval -46.3 to 2.08
|
|
CEMA
Day 22
|
-18.9 Percent change from baseline
Interval -43.2 to 15.7
|
-23.6 Percent change from baseline
Interval -46.8 to 9.75
|
|
CEMA
Day 29
|
-28.3 Percent change from baseline
Interval -52.9 to 9.07
|
-30.8 Percent change from baseline
Interval -50.2 to -3.87
|
SECONDARY outcome
Timeframe: Measured before product use, on day 1 and day 30.To measure percent change from baseline in CYP2A6 enzymatic activity, on day 30, as measured by molar metabolic ratio of trans-3-hydroxy-cotinine/cotinine in plasma.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=29 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
CYP2A6 Activity
|
15.5 Percent change from baseline
Interval -6.9 to 37.9
|
3.19 Percent change from baseline
Interval -13.0 to 19.4
|
SECONDARY outcome
Timeframe: Before and after product use, on day 1 and day 30.Weight difference (mg) of P3P before and after use, to determine the amount of powder extracted from P3P.
Outcome measures
| Measure |
P3P-1mg
n=30 Participants
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=28 Participants
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Amount of Powder Extracted From P3P Used for PK Assessment.
Day 1
|
24.1 mg
Interval 20.7 to 27.4
|
22.4 mg
Interval 19.2 to 25.6
|
|
Amount of Powder Extracted From P3P Used for PK Assessment.
Day 30
|
28.9 mg
Interval 25.4 to 32.4
|
24.2 mg
Interval 19.8 to 28.6
|
Adverse Events
P3P-1mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
P3P-2mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
P3P-1mg
n=30 participants at risk
Subjects randomized to exclusive use of P3P-1mg
P3P-1mg: P3P-1mg (P3P product containing 1mg of nicotine.)
|
P3P-2mg
n=30 participants at risk
Subjects randomized to exclusive use of P3P-2mg
P3P-2mg: P3P-2mg (P3P product containing 2mg of nicotine.)
|
|---|---|---|
|
Investigations
Blood Bilirubin Increased
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.
|
0.00%
0/30 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.
|
6.7%
2/30 • Number of events 4 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belong to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER