Phase 3
Completed N=1,198
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
Source: ClinicalTrials.gov NCT02355665 ↗Enrolled (actual)
1,198
Serious AEs
2.8%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 — 2.5; 5.0 Percentage of Participants — p=0.021
◆ Published Evidence
Emerging
12citations · ~2 / year
Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A Randomized, Multicenter, Controlled Study in a Naturalistic Setting.
Summary
The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.
Linked Publications
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Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A Randomized, Multicenter, Controlled Study in a Naturalistic Setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 |
2.5; 5.0 | 0.021 sig |
| SECONDARY Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 |
1.3; 4.0 | 0.004 sig |
| SECONDARY Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 |
1.2; 3.4 | 0.011 sig |
| SECONDARY Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 |
4.0; 6.7 | 0.040 sig |
| SECONDARY Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 |
2.2; 4.5 | 0.023 sig |
| SECONDARY Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16 |
1.3; 3.9 | 0.006 sig |
| SECONDARY Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20 |
1.3; 3.5 | 0.013 sig |
| SECONDARY Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 |
9.5; 12.8; 33.3; 35.9; 33.3; 25.6 | 0.847 |
| SECONDARY Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 |
24.0; 15.5; 28.0; 36.2; 20.0; 34.5 | 0.861 |
| SECONDARY Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 |
19.2; 37.2; 53.8; 39.5; 23.1; 16.3 | 0.266 |
| SECONDARY Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 |
43.8; 31.5; 31.3; 42.6; 12.5; 18.5 | 0.487 |
| SECONDARY Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 |
38.1; 51.3; 38.1; 28.2; 19.0; 15.4 | 0.433 |
| SECONDARY Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 |
28.0; 56.9; 40.0; 24.1; 12.0; 8.6 | 0.022 sig |
| SECONDARY Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 |
46.2; 55.8; 34.6; 23.3; 15.4; 11.6 | 0.665 |
| SECONDARY Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 |
43.8; 61.1; 43.8; 20.4; 6.3; 13.0 | 0.300 |
| SECONDARY Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 |
47.6; 43.6; 14.3; 30.8; 23.8; 17.9 | 0.754 |
| SECONDARY Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 |
40.0; 58.6; 32.0; 20.7; 12.0; 17.2 | 0.116 |
| SECONDARY Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 |
53.8; 62.8; 34.6; 32.6; 11.5; 2.3 | 0.392 |
| SECONDARY Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 |
46.9; 63.0; 37.5; 24.1; 9.4; 11.1 | 0.179 |
| SECONDARY Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 |
66.7; 69.2; 23.8; 17.9; 4.8; 7.7 | 0.925 |
| SECONDARY Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 |
52.0; 63.8; 32.0; 24.1; 8.0; 6.9 | 0.325 |
| SECONDARY Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 |
73.1; 74.4; 23.1; 11.6; 3.8; 9.3 | 0.891 |
| SECONDARY Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 |
71.9; 74.1; 12.5; 16.7; 9.4; 5.6 | 0.721 |
| SECONDARY Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 |
52.4; 59.0; 28.6; 28.2; 19.0; 7.7 | 0.608 |
| SECONDARY Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 |
44.0; 72.4; 24.0; 12.1; 12.0; 8.6 | 0.014 sig |
| SECONDARY Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 |
65.4; 65.1; 26.9; 23.3; 7.7; 11.6 | 0.900 |
| SECONDARY Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 |
62.5; 66.7; 25.0; 20.4; 6.3; 9.3 | 0.731 |
| SECONDARY Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 |
81.0; 87.2; 19.0; 5.1; 0.0; 5.1 | 0.635 |
| SECONDARY Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 |
72.0; 84.5; 20.0; 5.2; 8.0; 6.9 | 0.273 |
| SECONDARY Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 |
84.6; 86.0; 11.5; 9.3; 0.0; 2.3 | 0.879 |
| SECONDARY Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 |
78.1; 75.9; 15.6; 16.7; 3.1; 5.6 | 0.823 |
| SECONDARY Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 |
76.2; 79.5; 14.3; 12.8; 9.5; 2.6 | 0.804 |
| SECONDARY Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 |
76.0; 67.2; 16.0; 20.7; 0.0; 5.2 | 0.438 |
| SECONDARY Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 |
61.5; 69.8; 26.9; 20.9; 11.5; 7.0 | 0.517 |
| SECONDARY Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 |
62.5; 83.3; 21.9; 11.1; 6.3; 3.7 | 0.027 sig |
| SECONDARY Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 |
9.5; 43.6; 52.4; 28.2; 23.8; 5.1 | 0.105 |
| SECONDARY Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 |
28.0; 41.4; 36.0; 25.9; 24.0; 12.1 | 0.604 |
| SECONDARY Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 |
30.8; 44.2; 26.9; 30.2; 23.1; 11.6 | 0.194 |
| SECONDARY Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 |
21.9; 35.2; 43.8; 31.5; 18.8; 14.8 | 0.502 |
| SECONDARY Aggregated Withdrawal Score at Week 1 |
5.1; 4.5 | 0.483 |
| SECONDARY Aggregated Withdrawal Score at Week 2 |
6.3; 4.5 | 0.102 |
| SECONDARY Aggregated Withdrawal Score at Week 4 |
4.2; 3.7 | 0.532 |
| SECONDARY Aggregated Withdrawal Score at Week 6 |
4.8; 3.8 | 0.354 |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 1 |
15.6; 12.3 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 2 |
15.7; 11.8 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 3 |
14.6; 11.6 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 4 |
13.8; 11.3 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 5 |
14.2; 10.9 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 6 |
13.1; 10.5 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 7 |
12.3; 9.9 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 8 |
12.1; 10.1 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 9 |
11.8; 9.7 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 10 |
11.6; 9.3 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 11 |
11.3; 8.8 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 12 |
9.7; 7.9 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 13 |
10.2; 8.4 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 14 |
10.3; 9.2 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 15 |
10.5; 8.2 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 16 |
9.2; 8.0 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 17 |
9.2; 8.0 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 18 |
9.4; 8.2 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 19 |
9.1; 8.3 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 20 |
7.8; 8.2 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 21 |
7.8; 8.2 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 22 |
7.5; 7.8 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 23 |
7.7; 7.4 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 24 |
7.2; 7.2 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 25 |
6.6; 6.7 | — |
| SECONDARY Total Daily Number of Self-Reported Spray Doses at Week 26 |
6.3; 6.3 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 1 |
22.1; 17.2 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 2 |
21.2; 15.4 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 3 |
19.2; 15.2 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 4 |
17.9; 15.8 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 5 |
19.2; 15.1 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 6 |
17.5; 14.6 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 7 |
16.0; 12.8 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 8 |
16.0; 13.6 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 9 |
15.4; 12.2 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 10 |
14.7; 11.4 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 11 |
15.1; 11.2 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 12 |
12.6; 9.8 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 13 |
12.9; 10.5 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 14 |
13.1; 13.6 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 15 |
15.3; 10.8 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 16 |
12.4; 10.0 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 17 |
11.5; 10.5 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 18 |
12.3; 10.3 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 19 |
11.2; 10.3 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 20 |
10.5; 10.5 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 21 |
10.0; 11.0 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 22 |
9.4; 10.8 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 23 |
10.5; 9.1 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 24 |
9.2; 8.8 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 25 |
8.5; 8.4 | — |
| SECONDARY Maximum Total Daily Number of Self-Reported Spray Doses at Week 26 |
8.1; 7.9 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 1 |
6.0; 4.8 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 2 |
4.8; 3.4 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 3 |
4.3; 3.1 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 4 |
4.1; 3.0 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 5 |
3.7; 2.8 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 6 |
3.7; 2.7 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 7 |
3.6; 2.9 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 8 |
3.3; 2.6 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 9 |
3.3; 2.3 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 10 |
3.2; 2.3 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 11 |
3.0; 2.2 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 12 |
2.8; 2.0 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 13 |
2.7; 2.2 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 14 |
2.9; 2.2 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 15 |
2.6; 2.4 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 16 |
2.7; 2.1 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 17 |
2.5; 2.1 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 18 |
2.4; 2.3 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 19 |
2.6; 2.3 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 20 |
2.4; 2.0 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 21 |
2.3; 2.1 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 22 |
2.3; 2.0 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 23 |
2.1; 2.0 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 24 |
2.4; 1.9 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 25 |
2.0; 1.8 | — |
| SECONDARY Maximum Hourly Number of Self-Reported Spray Doses at Week 26 |
2.1; 1.8 | — |
| SECONDARY Number of Cigarettes Smoked Since Last Visit at Week 1 |
36.2; 34.0 | — |
| SECONDARY Number of Cigarettes Smoked Since Last Visit at Week 2 |
38.9; 35.8 | — |
| SECONDARY Number of Cigarettes Smoked Per Day at Week 4 |
7.3; 6.6 | — |
| SECONDARY Number of Cigarettes Smoked Per Day at Week 6 |
7.0; 6.6 | — |
| SECONDARY Number of Cigarettes Smoked Per Day at Week 8 |
6.8; 6.3 | — |
| SECONDARY Number of Cigarettes Smoked Per Day at Week 12 |
7.1; 7.5 | — |
| SECONDARY Number of Cigarettes Smoked Per Day at Week 16 |
7.7; 7.3 | — |
| SECONDARY Number of Cigarettes Smoked Per Day at Week 20 |
7.0; 7.2 | — |
| SECONDARY Number of Cigarettes Smoked Per Day at Week 26 |
7.2; 7.5 | — |
| SECONDARY Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 |
3.2; 1.8; 3.1; 2.6; 2.7; 3.9 | — |
| SECONDARY Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 |
5.3; 2.4; 2.1; 3.0; 4.5; 3.4 | — |
| SECONDARY Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 |
5.5; 3.5; 3.5; 2.3; 3.7; 3.3 | — |
| SECONDARY Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 |
8.7; 4.2; 27.8; 20.8; 34.5; 32.4 | — |
| SECONDARY Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 |
11.7; 5.4; 26.8; 19.5; 31.7; 32.5 | — |
| SECONDARY Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 |
12.7; 6.8; 20.1; 17.1; 32.1; 29.7 | — |
| SECONDARY Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 |
4.7; 1.8; 2.7; 1.5; 4.0; 2.0 | — |
| SECONDARY Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 |
5.5; 2.8; 4.9; 2.4; 4.7; 3.9 | — |
| SECONDARY Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 |
5.5; 4.0; 3.5; 1.6; 4.2; 2.6 | — |
| SECONDARY Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product |
2.5; 1.7; 4.3; 4.8; 50.9; 44.8 | — |
| SECONDARY Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product |
4.7; 4.3; 11.9; 7.7; 47.9; 46.9 | — |
| SECONDARY Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product |
9.0; 6.5; 9.0; 8.4; 46.0; 44.6 | — |
| SECONDARY Percentage Distribution of the Participant Score for Product Convenience at Week 1 |
0.9; 0.2; 3.2; 3.7; 10.1; 10.1 | — |
| SECONDARY Percentage Distribution of the Participant Score for Product Convenience at Week 6 |
0.9; 0.4; 4.7; 3.4; 8.7; 8.4 | — |
| SECONDARY Percentage Distribution of the Participant Score for Product Convenience at Week 12 |
1.5; 0.2; 3.0; 4.0; 9.0; 9.1 | — |
| SECONDARY Systolic Blood Pressure at Week 1 |
123.7; 124.7 | — |
| SECONDARY Systolic Blood Pressure at Week 2 |
123.3; 123.7 | — |
| SECONDARY Systolic Blood Pressure at Week 4 |
122.5; 122.9 | — |
| SECONDARY Systolic Blood Pressure at Week 6 |
122.3; 122.4 | — |
| SECONDARY Systolic Blood Pressure at Week 8 |
122.0; 122.7 | — |
| SECONDARY Systolic Blood Pressure at Week 12 |
121.8; 122.7 | — |
| SECONDARY Systolic Blood Pressure at Week 16 |
122.3; 122.8 | — |
| SECONDARY Systolic Blood Pressure at Week 20 |
122.4; 123.2 | — |
| SECONDARY Systolic Blood Pressure at Week 26 |
123.2; 124.8 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 1 |
-0.2; 0.2 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 2 |
-0.7; -0.7 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 4 |
-1.8; -1.9 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 6 |
-2.0; -2.2 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 8 |
-1.8; -2.2 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 12 |
-2.2; -2.4 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 16 |
-1.8; -2.8 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 20 |
-1.7; -2.0 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 26 |
-0.6; -0.6 | — |
| SECONDARY Diastolic Blood Pressure at Week 1 |
77.3; 78.0 | — |
| SECONDARY Diastolic Blood Pressure at Week 2 |
76.7; 78.0 | — |
| SECONDARY Diastolic Blood Pressure at Week 4 |
76.9; 77.6 | — |
| SECONDARY Diastolic Blood Pressure at Week 6 |
76.6; 76.5 | — |
| SECONDARY Diastolic Blood Pressure at Week 8 |
76.5; 77.3 | — |
| SECONDARY Diastolic Blood Pressure at Week 12 |
76.6; 77.4 | — |
| SECONDARY Diastolic Blood Pressure at Week 16 |
76.4; 77.0 | — |
| SECONDARY Diastolic Blood Pressure at Week 20 |
76.3; 76.8 | — |
| SECONDARY Diastolic Blood Pressure at Week 26 |
76.9; 78.1 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 1 |
0.1; 0.5 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 2 |
-0.4; 0.4 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 4 |
-0.3; -0.1 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 6 |
-0.6; -1.0 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 8 |
-0.4; -0.1 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 12 |
-0.4; -0.4 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 16 |
-0.6; -0.8 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 20 |
-0.8; -0.5 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 26 |
-0.1; 0.7 | — |
| SECONDARY Pulse at Week 1 |
76.1; 76.8 | — |
| SECONDARY Pulse at Week 2 |
75.9; 76.5 | — |
| SECONDARY Pulse at Week 4 |
75.6; 77.0 | — |
| SECONDARY Pulse at Week 6 |
75.3; 75.2 | — |
| SECONDARY Pulse at Week 8 |
75.4; 77.3 | — |
| SECONDARY Pulse at Week 12 |
75.1; 76.1 | — |
| SECONDARY Pulse at Week 16 |
76.9; 76.2 | — |
| SECONDARY Pulse at Week 20 |
76.4; 76.2 | — |
| SECONDARY Pulse at Week 26 |
76.9; 76.0 | — |
| SECONDARY Change From Baseline in Pulse at Week 1 |
1.4; 2.0 | — |
| SECONDARY Change From Baseline in Pulse at Week 2 |
1.2; 1.8 | — |
| SECONDARY Change From Baseline in Pulse at Week 4 |
1.3; 2.4 | — |
| SECONDARY Change From Baseline in Pulse at Week 6 |
1.0; 0.7 | — |
| SECONDARY Change From Baseline in Pulse at Week 8 |
1.2; 2.7 | — |
| SECONDARY Change From Baseline in Pulse at Week 12 |
0.9; 1.8 | — |
| SECONDARY Change From Baseline in Pulse at Week 16 |
2.8; 1.9 | — |
| SECONDARY Change From Baseline in Pulse at Week 20 |
2.7; 2.0 | — |
| SECONDARY Change From Baseline in Pulse at Week 26 |
3.2; 1.8 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study |
0.4; 1.0 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study |
1.2; 1.6 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study |
0.2; 0.0 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study |
0.2; 1.0 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study |
0.8; 0.8 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study |
0.4; 1.0 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study |
0.4; 0.2 | — |
| SECONDARY Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study |
1.8; 3.6 | — |
| SECONDARY Change From Baseline in Body Weight at Week 6 |
0.5; 0.7 | — |
| SECONDARY Change From Baseline in Body Weight at Week 12 |
-0.3; 0.4 | — |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
-0.2; 1.0 | — |
| SECONDARY Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit |
3.6; 3.7 | 0.558 |
| SECONDARY Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit |
4.2; 6.4 | 0.383 |
| SECONDARY Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit |
2.5; 9.3 | 0.138 |
Eligibility Criteria
Inclusion Criteria
Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking
Exclusion Criteria
History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.
Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.
Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.
Pregnancy or intending to become pregnant.
Hypersensitivity to the product, history of alcohol or substance abuse.
Data sourced from ClinicalTrials.gov (NCT02355665) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.