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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,198
Nicotine Spray
Placebo to match nicotine spray
Mayo Clinic
Scottsdale, Arizona, United States
Los Angeles Clinical Trials
Burbank, California, United States
Radiant Research, Inc
Chicago, Illinois, United States
University of Maryland
College Park, Maryland, United States
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
Time frame: Week 2 to Week 6
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 2 to Week 16
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Radiant Research, Inc.
Akron, Ohio, United States
Radiant Research
Cincinnati, Ohio, United States
Radiant Research, Inc
Dallas, Texas, United States
Radiant Research, Inc
Salt Lake City, Utah, United States
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 6
Total Daily Number of Self-Reported Spray Doses at Week 1
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 1
Total Daily Number of Self-Reported Spray Doses at Week 2
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 2
Total Daily Number of Self-Reported Spray Doses at Week 3
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 3
Total Daily Number of Self-Reported Spray Doses at Week 4
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 4
Total Daily Number of Self-Reported Spray Doses at Week 5
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 5
Total Daily Number of Self-Reported Spray Doses at Week 6
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 6
Total Daily Number of Self-Reported Spray Doses at Week 7
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 7
Total Daily Number of Self-Reported Spray Doses at Week 8
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 8
Total Daily Number of Self-Reported Spray Doses at Week 9
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 9
Total Daily Number of Self-Reported Spray Doses at Week 10
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 10
Total Daily Number of Self-Reported Spray Doses at Week 11
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 11
Total Daily Number of Self-Reported Spray Doses at Week 12
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 12
Total Daily Number of Self-Reported Spray Doses at Week 13
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 13
Total Daily Number of Self-Reported Spray Doses at Week 14
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 14
Total Daily Number of Self-Reported Spray Doses at Week 15
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 15
Total Daily Number of Self-Reported Spray Doses at Week 16
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 16
Total Daily Number of Self-Reported Spray Doses at Week 17
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 17
Total Daily Number of Self-Reported Spray Doses at Week 18
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 18
Total Daily Number of Self-Reported Spray Doses at Week 19
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 19
Total Daily Number of Self-Reported Spray Doses at Week 20
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 20
Total Daily Number of Self-Reported Spray Doses at Week 21
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 21
Total Daily Number of Self-Reported Spray Doses at Week 22
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 22
Total Daily Number of Self-Reported Spray Doses at Week 23
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 23
Total Daily Number of Self-Reported Spray Doses at Week 24
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 24
Total Daily Number of Self-Reported Spray Doses at Week 25
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 25
Total Daily Number of Self-Reported Spray Doses at Week 26
Total Daily Number of Self-Reported Spray Doses
Time frame: Week 26
Maximum Total Daily Number of Self-Reported Spray Doses at Week 1
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 1
Maximum Total Daily Number of Self-Reported Spray Doses at Week 2
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 2
Maximum Total Daily Number of Self-Reported Spray Doses at Week 3
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 3
Maximum Total Daily Number of Self-Reported Spray Doses at Week 4
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 4
Maximum Total Daily Number of Self-Reported Spray Doses at Week 5
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 5
Maximum Total Daily Number of Self-Reported Spray Doses at Week 6
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 6
Maximum Total Daily Number of Self-Reported Spray Doses at Week 7
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 7
Maximum Total Daily Number of Self-Reported Spray Doses at Week 8
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 8
Maximum Total Daily Number of Self-Reported Spray Doses at Week 9
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 9
Maximum Total Daily Number of Self-Reported Spray Doses at Week 10
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 10
Maximum Total Daily Number of Self-Reported Spray Doses at Week 11
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 11
Maximum Total Daily Number of Self-Reported Spray Doses at Week 12
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 12
Maximum Total Daily Number of Self-Reported Spray Doses at Week 13
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 13
Maximum Total Daily Number of Self-Reported Spray Doses at Week 14
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 14
Maximum Total Daily Number of Self-Reported Spray Doses at Week 15
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 15
Maximum Total Daily Number of Self-Reported Spray Doses at Week 16
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 16
Maximum Total Daily Number of Self-Reported Spray Doses at Week 17
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 17
Maximum Total Daily Number of Self-Reported Spray Doses at Week 18
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 18
Maximum Total Daily Number of Self-Reported Spray Doses at Week 19
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 19
Maximum Total Daily Number of Self-Reported Spray Doses at Week 20
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 20
Maximum Total Daily Number of Self-Reported Spray Doses at Week 21
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 21
Maximum Total Daily Number of Self-Reported Spray Doses at Week 22
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 22
Maximum Total Daily Number of Self-Reported Spray Doses at Week 23
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 23
Maximum Total Daily Number of Self-Reported Spray Doses at Week 24
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 24
Maximum Total Daily Number of Self-Reported Spray Doses at Week 25
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 25
Maximum Total Daily Number of Self-Reported Spray Doses at Week 26
Maximum Total Daily Number of Self-Reported Spray Doses
Time frame: Week 26
Maximum Hourly Number of Self-Reported Spray Doses at Week 1
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 1
Maximum Hourly Number of Self-Reported Spray Doses at Week 2
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 2
Maximum Hourly Number of Self-Reported Spray Doses at Week 3
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 3
Maximum Hourly Number of Self-Reported Spray Doses at Week 4
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 4
Maximum Hourly Number of Self-Reported Spray Doses at Week 5
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 5
Maximum Hourly Number of Self-Reported Spray Doses at Week 6
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 6
Maximum Hourly Number of Self-Reported Spray Doses at Week 7
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 7
Maximum Hourly Number of Self-Reported Spray Doses at Week 8
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 8
Maximum Hourly Number of Self-Reported Spray Doses at Week 9
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 9
Maximum Hourly Number of Self-Reported Spray Doses at Week 10
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 10
Maximum Hourly Number of Self-Reported Spray Doses at Week 11
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 11
Maximum Hourly Number of Self-Reported Spray Doses at Week 12
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 12
Maximum Hourly Number of Self-Reported Spray Doses at Week 13
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 13
Maximum Hourly Number of Self-Reported Spray Doses at Week 14
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 14
Maximum Hourly Number of Self-Reported Spray Doses at Week 15
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 15
Maximum Hourly Number of Self-Reported Spray Doses at Week 16
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 16
Maximum Hourly Number of Self-Reported Spray Doses at Week 17
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 17
Maximum Hourly Number of Self-Reported Spray Doses at Week 18
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 18
Maximum Hourly Number of Self-Reported Spray Doses at Week 19
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 19
Maximum Hourly Number of Self-Reported Spray Doses at Week 20
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 20
Maximum Hourly Number of Self-Reported Spray Doses at Week 21
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 21
Maximum Hourly Number of Self-Reported Spray Doses at Week 22
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 22
Maximum Hourly Number of Self-Reported Spray Doses at Week 23
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 23
Maximum Hourly Number of Self-Reported Spray Doses at Week 24
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 24
Maximum Hourly Number of Self-Reported Spray Doses at Week 25
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 25
Maximum Hourly Number of Self-Reported Spray Doses at Week 26
Maximum Hourly Number of Self-Reported Spray Doses
Time frame: Week 26
Number of Cigarettes Smoked Since Last Visit at Week 1
Number of Cigarettes Smoked Since Last Visit
Time frame: Week 1
Number of Cigarettes Smoked Since Last Visit at Week 2
Number of Cigarettes Smoked Since Last Visit
Time frame: Week 2
Number of Cigarettes Smoked Per Day at Week 4
Number of Cigarettes Smoked Per Day
Time frame: Week 4
Number of Cigarettes Smoked Per Day at Week 6
Number of Cigarettes Smoked Per Day
Time frame: Week 6
Number of Cigarettes Smoked Per Day at Week 8
Number of Cigarettes Smoked Per Day
Time frame: Week 8
Number of Cigarettes Smoked Per Day at Week 12
Number of Cigarettes Smoked Per Day
Time frame: Week 12
Number of Cigarettes Smoked Per Day at Week 16
Number of Cigarettes Smoked Per Day
Time frame: Week 16
Number of Cigarettes Smoked Per Day at Week 20
Number of Cigarettes Smoked Per Day
Time frame: Week 20
Number of Cigarettes Smoked Per Day at Week 26
Number of Cigarettes Smoked Per Day
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Week 12
Systolic Blood Pressure at Week 1
Systolic blood pressure (mm Hg)
Time frame: Week 1
Systolic Blood Pressure at Week 2
Systolic blood pressure (mm Hg)
Time frame: Week 2
Systolic Blood Pressure at Week 4
Systolic blood pressure (mm Hg)
Time frame: Week 4
Systolic Blood Pressure at Week 6
Systolic blood pressure (mm Hg)
Time frame: Week 6
Systolic Blood Pressure at Week 8
Systolic blood pressure (mm Hg)
Time frame: Week 8
Systolic Blood Pressure at Week 12
Systolic blood pressure (mm Hg)
Time frame: Week 12
Systolic Blood Pressure at Week 16
Systolic blood pressure (mm Hg)
Time frame: Week 16
Systolic Blood Pressure at Week 20
Systolic blood pressure (mm Hg)
Time frame: Week 20
Systolic Blood Pressure at Week 26
Systolic blood pressure (mm Hg)
Time frame: Week 26
Change From Baseline in Systolic Blood Pressure at Week 1
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 1
Change From Baseline in Systolic Blood Pressure at Week 2
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 2
Change From Baseline in Systolic Blood Pressure at Week 4
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 4
Change From Baseline in Systolic Blood Pressure at Week 6
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 6
Change From Baseline in Systolic Blood Pressure at Week 8
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 8
Change From Baseline in Systolic Blood Pressure at Week 12
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 12
Change From Baseline in Systolic Blood Pressure at Week 16
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 16
Change From Baseline in Systolic Blood Pressure at Week 20
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 20
Change From Baseline in Systolic Blood Pressure at Week 26
Change from baseline in systolic blood pressure (mm Hg)
Time frame: Baseline to Week 26
Diastolic Blood Pressure at Week 1
Diastolic blood pressure (mm Hg)
Time frame: Week 1
Diastolic Blood Pressure at Week 2
Diastolic blood pressure (mm Hg)
Time frame: Week 2
Diastolic Blood Pressure at Week 4
Diastolic blood pressure (mm Hg)
Time frame: Week 4
Diastolic Blood Pressure at Week 6
Diastolic blood pressure (mm Hg)
Time frame: Week 6
Diastolic Blood Pressure at Week 8
Diastolic blood pressure (mm Hg)
Time frame: Week 8
Diastolic Blood Pressure at Week 12
Diastolic blood pressure (mm Hg)
Time frame: Week 12
Diastolic Blood Pressure at Week 16
Diastolic blood pressure (mm Hg)
Time frame: Week 16
Diastolic Blood Pressure at Week 20
Diastolic blood pressure (mm Hg)
Time frame: Week 20
Diastolic Blood Pressure at Week 26
Diastolic blood pressure (mm Hg)
Time frame: Week 26
Change From Baseline in Diastolic Blood Pressure at Week 1
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 1
Change From Baseline in Diastolic Blood Pressure at Week 2
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 2
Change From Baseline in Diastolic Blood Pressure at Week 4
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 4
Change From Baseline in Diastolic Blood Pressure at Week 6
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 6
Change From Baseline in Diastolic Blood Pressure at Week 8
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 8
Change From Baseline in Diastolic Blood Pressure at Week 12
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 12
Change From Baseline in Diastolic Blood Pressure at Week 16
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 16
Change From Baseline in Diastolic Blood Pressure at Week 20
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 20
Change From Baseline in Diastolic Blood Pressure at Week 26
Change from baseline in diastolic blood pressure (mm Hg)
Time frame: Baseline to Week 26
Pulse at Week 1
Pulse (beats per minute)
Time frame: Week 1
Pulse at Week 2
Pulse (beats per minute)
Time frame: Week 2
Pulse at Week 4
Pulse (beats per minute)
Time frame: Week 4
Pulse at Week 6
Pulse (beats per minute)
Time frame: Week 6
Pulse at Week 8
Pulse (beats per minute)
Time frame: Week 8
Pulse at Week 12
Pulse (beats per minute)
Time frame: Week 12
Pulse at Week 16
Pulse (beats per minute)
Time frame: Week 16
Pulse at Week 20
Pulse (beats per minute)
Time frame: Week 20
Pulse at Week 26
Pulse (beats per minute)
Time frame: Week 26
Change From Baseline in Pulse at Week 1
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 1
Change From Baseline in Pulse at Week 2
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 2
Change From Baseline in Pulse at Week 4
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 4
Change From Baseline in Pulse at Week 6
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 6
Change From Baseline in Pulse at Week 8
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 8
Change From Baseline in Pulse at Week 12
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 12
Change From Baseline in Pulse at Week 16
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 16
Change From Baseline in Pulse at Week 20
Change from baseline in pulse (beats per minute)
Time frame: Baseline to Week 20
Change From Baseline in Pulse at Week 26
Change from baseline in pulse (beats per minute)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 6 or when withdrawn from study
Change From Baseline in Body Weight at Week 6
Change from baseline in body weight
Time frame: Baseline to Week 6
Change From Baseline in Body Weight at Week 12
Change from baseline in body weight
Time frame: Baseline to Week 12
Change From Baseline in Body Weight at Week 26
Change from baseline in body weight
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 26