Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

Study Overview
=================
Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Using a Naturalistic Clinical Model to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers Motivated to Quit

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Nicotine Spray
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine<br>Nicotine Spray | Drug: Nicotine Spray<br>* Nicotine Spray<br>|
| Placebo Comparator: Placebo<br>Placebo to match Nicotine spray | Drug: Placebo<br>* Placebo to match nicotine spray<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking | Week 2 to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking | Week 2 to Week 12 | 
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking | Week 2 to Week 26 | 
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking | Week 2 to Week 4 | 
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking | Week 2 to Week 8 | 
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking | Week 2 to Week 16 | 
| Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20 | Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking | Week 2 to Week 20 | 
| Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 1 | 
| Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 2 | 
| Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 4 | 
| Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6 | Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 6 | 
| Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1 | Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 1 | 
| Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2 | Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 2 | 
| Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4 | Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 4 | 
| Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 | Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 6 | 
| Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1 | Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 1 | 
| Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 | Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 2 | 
| Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4 | Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 4 | 
| Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6 | Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 6 | 
| Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 | Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 1 | 
| Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 | Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 2 | 
| Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4 | Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 4 | 
| Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6 | Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 6 | 
| Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1 | Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 1 | 
| Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2 | Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 2 | 
| Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4 | Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 4 | 
| Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 | Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 6 | 
| Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1 | Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 1 | 
| Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 | Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 2 | 
| Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4 | Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 4 | 
| Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6 | Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 6 | 
| Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 | Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 1 | 
| Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 | Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 2 | 
| Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4 | Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 4 | 
| Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6 | Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 6 | 
| Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1 | Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 1 | 
| Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2 | Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 2 | 
| Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4 | Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 4 | 
| Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 | Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). | Week 6 | 
| Aggregated Withdrawal Score at Week 1 | Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28. | Week 1 | 
| Aggregated Withdrawal Score at Week 2 | Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28. | Week 2 | 
| Aggregated Withdrawal Score at Week 4 | Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28. | Week 4 | 
| Aggregated Withdrawal Score at Week 6 | Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28. | Week 6 | 
| Total Daily Number of Self-Reported Spray Doses at Week 1 | Total Daily Number of Self-Reported Spray Doses | Week 1 | 
| Total Daily Number of Self-Reported Spray Doses at Week 2 | Total Daily Number of Self-Reported Spray Doses | Week 2 | 
| Total Daily Number of Self-Reported Spray Doses at Week 3 | Total Daily Number of Self-Reported Spray Doses | Week 3 | 
| Total Daily Number of Self-Reported Spray Doses at Week 4 | Total Daily Number of Self-Reported Spray Doses | Week 4 | 
| Total Daily Number of Self-Reported Spray Doses at Week 5 | Total Daily Number of Self-Reported Spray Doses | Week 5 | 
| Total Daily Number of Self-Reported Spray Doses at Week 6 | Total Daily Number of Self-Reported Spray Doses | Week 6 | 
| Total Daily Number of Self-Reported Spray Doses at Week 7 | Total Daily Number of Self-Reported Spray Doses | Week 7 | 
| Total Daily Number of Self-Reported Spray Doses at Week 8 | Total Daily Number of Self-Reported Spray Doses | Week 8 | 
| Total Daily Number of Self-Reported Spray Doses at Week 9 | Total Daily Number of Self-Reported Spray Doses | Week 9 | 
| Total Daily Number of Self-Reported Spray Doses at Week 10 | Total Daily Number of Self-Reported Spray Doses | Week 10 | 
| Total Daily Number of Self-Reported Spray Doses at Week 11 | Total Daily Number of Self-Reported Spray Doses | Week 11 | 
| Total Daily Number of Self-Reported Spray Doses at Week 12 | Total Daily Number of Self-Reported Spray Doses | Week 12 | 
| Total Daily Number of Self-Reported Spray Doses at Week 13 | Total Daily Number of Self-Reported Spray Doses | Week 13 | 
| Total Daily Number of Self-Reported Spray Doses at Week 14 | Total Daily Number of Self-Reported Spray Doses | Week 14 | 
| Total Daily Number of Self-Reported Spray Doses at Week 15 | Total Daily Number of Self-Reported Spray Doses | Week 15 | 
| Total Daily Number of Self-Reported Spray Doses at Week 16 | Total Daily Number of Self-Reported Spray Doses | Week 16 | 
| Total Daily Number of Self-Reported Spray Doses at Week 17 | Total Daily Number of Self-Reported Spray Doses | Week 17 | 
| Total Daily Number of Self-Reported Spray Doses at Week 18 | Total Daily Number of Self-Reported Spray Doses | Week 18 | 
| Total Daily Number of Self-Reported Spray Doses at Week 19 | Total Daily Number of Self-Reported Spray Doses | Week 19 | 
| Total Daily Number of Self-Reported Spray Doses at Week 20 | Total Daily Number of Self-Reported Spray Doses | Week 20 | 
| Total Daily Number of Self-Reported Spray Doses at Week 21 | Total Daily Number of Self-Reported Spray Doses | Week 21 | 
| Total Daily Number of Self-Reported Spray Doses at Week 22 | Total Daily Number of Self-Reported Spray Doses | Week 22 | 
| Total Daily Number of Self-Reported Spray Doses at Week 23 | Total Daily Number of Self-Reported Spray Doses | Week 23 | 
| Total Daily Number of Self-Reported Spray Doses at Week 24 | Total Daily Number of Self-Reported Spray Doses | Week 24 | 
| Total Daily Number of Self-Reported Spray Doses at Week 25 | Total Daily Number of Self-Reported Spray Doses | Week 25 | 
| Total Daily Number of Self-Reported Spray Doses at Week 26 | Total Daily Number of Self-Reported Spray Doses | Week 26 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 1 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 1 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 2 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 2 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 3 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 3 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 4 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 4 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 5 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 5 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 6 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 6 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 7 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 7 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 8 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 8 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 9 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 9 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 10 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 10 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 11 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 11 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 12 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 12 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 13 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 13 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 14 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 14 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 15 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 15 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 16 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 16 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 17 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 17 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 18 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 18 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 19 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 19 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 20 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 20 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 21 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 21 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 22 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 22 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 23 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 23 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 24 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 24 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 25 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 25 | 
| Maximum Total Daily Number of Self-Reported Spray Doses at Week 26 | Maximum Total Daily Number of Self-Reported Spray Doses | Week 26 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 1 | Maximum Hourly Number of Self-Reported Spray Doses | Week 1 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 2 | Maximum Hourly Number of Self-Reported Spray Doses | Week 2 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 3 | Maximum Hourly Number of Self-Reported Spray Doses | Week 3 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 4 | Maximum Hourly Number of Self-Reported Spray Doses | Week 4 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 5 | Maximum Hourly Number of Self-Reported Spray Doses | Week 5 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 6 | Maximum Hourly Number of Self-Reported Spray Doses | Week 6 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 7 | Maximum Hourly Number of Self-Reported Spray Doses | Week 7 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 8 | Maximum Hourly Number of Self-Reported Spray Doses | Week 8 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 9 | Maximum Hourly Number of Self-Reported Spray Doses | Week 9 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 10 | Maximum Hourly Number of Self-Reported Spray Doses | Week 10 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 11 | Maximum Hourly Number of Self-Reported Spray Doses | Week 11 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 12 | Maximum Hourly Number of Self-Reported Spray Doses | Week 12 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 13 | Maximum Hourly Number of Self-Reported Spray Doses | Week 13 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 14 | Maximum Hourly Number of Self-Reported Spray Doses | Week 14 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 15 | Maximum Hourly Number of Self-Reported Spray Doses | Week 15 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 16 | Maximum Hourly Number of Self-Reported Spray Doses | Week 16 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 17 | Maximum Hourly Number of Self-Reported Spray Doses | Week 17 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 18 | Maximum Hourly Number of Self-Reported Spray Doses | Week 18 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 19 | Maximum Hourly Number of Self-Reported Spray Doses | Week 19 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 20 | Maximum Hourly Number of Self-Reported Spray Doses | Week 20 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 21 | Maximum Hourly Number of Self-Reported Spray Doses | Week 21 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 22 | Maximum Hourly Number of Self-Reported Spray Doses | Week 22 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 23 | Maximum Hourly Number of Self-Reported Spray Doses | Week 23 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 24 | Maximum Hourly Number of Self-Reported Spray Doses | Week 24 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 25 | Maximum Hourly Number of Self-Reported Spray Doses | Week 25 | 
| Maximum Hourly Number of Self-Reported Spray Doses at Week 26 | Maximum Hourly Number of Self-Reported Spray Doses | Week 26 | 
| Number of Cigarettes Smoked Since Last Visit at Week 1 | Number of Cigarettes Smoked Since Last Visit | Week 1 | 
| Number of Cigarettes Smoked Since Last Visit at Week 2 | Number of Cigarettes Smoked Since Last Visit | Week 2 | 
| Number of Cigarettes Smoked Per Day at Week 4 | Number of Cigarettes Smoked Per Day | Week 4 | 
| Number of Cigarettes Smoked Per Day at Week 6 | Number of Cigarettes Smoked Per Day | Week 6 | 
| Number of Cigarettes Smoked Per Day at Week 8 | Number of Cigarettes Smoked Per Day | Week 8 | 
| Number of Cigarettes Smoked Per Day at Week 12 | Number of Cigarettes Smoked Per Day | Week 12 | 
| Number of Cigarettes Smoked Per Day at Week 16 | Number of Cigarettes Smoked Per Day | Week 16 | 
| Number of Cigarettes Smoked Per Day at Week 20 | Number of Cigarettes Smoked Per Day | Week 20 | 
| Number of Cigarettes Smoked Per Day at Week 26 | Number of Cigarettes Smoked Per Day | Week 26 | 
| Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 | Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent). | Week 1 | 
| Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 | Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent). | Week 6 | 
| Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 | Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent). | Week 12 | 
| Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 | Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective). | Week 1 | 
| Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 | Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective). | Week 6 | 
| Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12 | Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective). | Week 12 | 
| Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1 | Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast). | Week 1 | 
| Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 | Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast). | Week 6 | 
| Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12 | Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast). | Week 12 | 
| Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product | Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now). | Week 1 | 
| Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product | Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now). | Week 6 | 
| Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product | Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now). | Week 12 | 
| Percentage Distribution of the Participant Score for Product Convenience at Week 1 | Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient). | Week 1 | 
| Percentage Distribution of the Participant Score for Product Convenience at Week 6 | Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient). | Week 6 | 
| Percentage Distribution of the Participant Score for Product Convenience at Week 12 | Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient). | Week 12 | 
| Systolic Blood Pressure at Week 1 | Systolic blood pressure (mm Hg) | Week 1 | 
| Systolic Blood Pressure at Week 2 | Systolic blood pressure (mm Hg) | Week 2 | 
| Systolic Blood Pressure at Week 4 | Systolic blood pressure (mm Hg) | Week 4 | 
| Systolic Blood Pressure at Week 6 | Systolic blood pressure (mm Hg) | Week 6 | 
| Systolic Blood Pressure at Week 8 | Systolic blood pressure (mm Hg) | Week 8 | 
| Systolic Blood Pressure at Week 12 | Systolic blood pressure (mm Hg) | Week 12 | 
| Systolic Blood Pressure at Week 16 | Systolic blood pressure (mm Hg) | Week 16 | 
| Systolic Blood Pressure at Week 20 | Systolic blood pressure (mm Hg) | Week 20 | 
| Systolic Blood Pressure at Week 26 | Systolic blood pressure (mm Hg) | Week 26 | 
| Change From Baseline in Systolic Blood Pressure at Week 1 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 1 | 
| Change From Baseline in Systolic Blood Pressure at Week 2 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 2 | 
| Change From Baseline in Systolic Blood Pressure at Week 4 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 4 | 
| Change From Baseline in Systolic Blood Pressure at Week 6 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 6 | 
| Change From Baseline in Systolic Blood Pressure at Week 8 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 8 | 
| Change From Baseline in Systolic Blood Pressure at Week 12 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 12 | 
| Change From Baseline in Systolic Blood Pressure at Week 16 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 16 | 
| Change From Baseline in Systolic Blood Pressure at Week 20 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 20 | 
| Change From Baseline in Systolic Blood Pressure at Week 26 | Change from baseline in systolic blood pressure (mm Hg) | Baseline to Week 26 | 
| Diastolic Blood Pressure at Week 1 | Diastolic blood pressure (mm Hg) | Week 1 | 
| Diastolic Blood Pressure at Week 2 | Diastolic blood pressure (mm Hg) | Week 2 | 
| Diastolic Blood Pressure at Week 4 | Diastolic blood pressure (mm Hg) | Week 4 | 
| Diastolic Blood Pressure at Week 6 | Diastolic blood pressure (mm Hg) | Week 6 | 
| Diastolic Blood Pressure at Week 8 | Diastolic blood pressure (mm Hg) | Week 8 | 
| Diastolic Blood Pressure at Week 12 | Diastolic blood pressure (mm Hg) | Week 12 | 
| Diastolic Blood Pressure at Week 16 | Diastolic blood pressure (mm Hg) | Week 16 | 
| Diastolic Blood Pressure at Week 20 | Diastolic blood pressure (mm Hg) | Week 20 | 
| Diastolic Blood Pressure at Week 26 | Diastolic blood pressure (mm Hg) | Week 26 | 
| Change From Baseline in Diastolic Blood Pressure at Week 1 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 1 | 
| Change From Baseline in Diastolic Blood Pressure at Week 2 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 2 | 
| Change From Baseline in Diastolic Blood Pressure at Week 4 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 4 | 
| Change From Baseline in Diastolic Blood Pressure at Week 6 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 6 | 
| Change From Baseline in Diastolic Blood Pressure at Week 8 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 8 | 
| Change From Baseline in Diastolic Blood Pressure at Week 12 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 12 | 
| Change From Baseline in Diastolic Blood Pressure at Week 16 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 16 | 
| Change From Baseline in Diastolic Blood Pressure at Week 20 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 20 | 
| Change From Baseline in Diastolic Blood Pressure at Week 26 | Change from baseline in diastolic blood pressure (mm Hg) | Baseline to Week 26 | 
| Pulse at Week 1 | Pulse (beats per minute) | Week 1 | 
| Pulse at Week 2 | Pulse (beats per minute) | Week 2 | 
| Pulse at Week 4 | Pulse (beats per minute) | Week 4 | 
| Pulse at Week 6 | Pulse (beats per minute) | Week 6 | 
| Pulse at Week 8 | Pulse (beats per minute) | Week 8 | 
| Pulse at Week 12 | Pulse (beats per minute) | Week 12 | 
| Pulse at Week 16 | Pulse (beats per minute) | Week 16 | 
| Pulse at Week 20 | Pulse (beats per minute) | Week 20 | 
| Pulse at Week 26 | Pulse (beats per minute) | Week 26 | 
| Change From Baseline in Pulse at Week 1 | Change from baseline in pulse (beats per minute) | Baseline to Week 1 | 
| Change From Baseline in Pulse at Week 2 | Change from baseline in pulse (beats per minute) | Baseline to Week 2 | 
| Change From Baseline in Pulse at Week 4 | Change from baseline in pulse (beats per minute) | Baseline to Week 4 | 
| Change From Baseline in Pulse at Week 6 | Change from baseline in pulse (beats per minute) | Baseline to Week 6 | 
| Change From Baseline in Pulse at Week 8 | Change from baseline in pulse (beats per minute) | Baseline to Week 8 | 
| Change From Baseline in Pulse at Week 12 | Change from baseline in pulse (beats per minute) | Baseline to Week 12 | 
| Change From Baseline in Pulse at Week 16 | Change from baseline in pulse (beats per minute) | Baseline to Week 16 | 
| Change From Baseline in Pulse at Week 20 | Change from baseline in pulse (beats per minute) | Baseline to Week 20 | 
| Change From Baseline in Pulse at Week 26 | Change from baseline in pulse (beats per minute) | Baseline to Week 26 | 
| Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study | Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings. | Week 6 or when withdrawn from study | 
| Change From Baseline in Body Weight at Week 6 | Change from baseline in body weight | Baseline to Week 6 | 
| Change From Baseline in Body Weight at Week 12 | Change from baseline in body weight | Baseline to Week 12 | 
| Change From Baseline in Body Weight at Week 26 | Change from baseline in body weight | Baseline to Week 26 | 
| Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | Change from baseline in body weight | Baseline to Week 6 | 
| Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | Change from baseline in body weight | Baseline to Week 12 | 
| Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit | Change from baseline in body weight | Baseline to Week 26 |