Back to resultsStudy to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
Primary Purpose
Tobacco Dependence
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nicotine Spray
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Dependence
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.
Sites / Locations
- Mayo Clinic
- Los Angeles Clinical Trials
- Radiant Research, Inc
- University of Maryland
- Radiant Research, Inc.
- Radiant Research
- Radiant Research, Inc
- Radiant Research, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nicotine
Placebo
Arm Description
Nicotine Spray
Placebo to match Nicotine spray
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
Total Daily Number of Self-Reported Spray Doses at Week 1
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 2
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 3
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 4
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 5
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 6
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 7
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 8
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 9
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 10
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 11
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 12
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 13
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 14
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 15
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 16
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 17
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 18
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 19
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 20
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 21
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 22
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 23
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 24
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 25
Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 26
Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 1
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 2
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 3
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 4
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 5
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 6
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 7
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 8
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 9
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 10
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 11
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 12
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 13
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 14
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 15
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 16
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 17
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 18
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 19
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 20
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 21
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 22
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 23
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 24
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 25
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 26
Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 1
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 2
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 3
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 4
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 5
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 6
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 7
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 8
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 9
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 10
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 11
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 12
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 13
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 14
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 15
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 16
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 17
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 18
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 19
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 20
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 21
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 22
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 23
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 24
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 25
Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 26
Maximum Hourly Number of Self-Reported Spray Doses
Number of Cigarettes Smoked Since Last Visit at Week 1
Number of Cigarettes Smoked Since Last Visit
Number of Cigarettes Smoked Since Last Visit at Week 2
Number of Cigarettes Smoked Since Last Visit
Number of Cigarettes Smoked Per Day at Week 4
Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day at Week 6
Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day at Week 8
Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day at Week 12
Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day at Week 16
Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day at Week 20
Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day at Week 26
Number of Cigarettes Smoked Per Day
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Systolic Blood Pressure at Week 1
Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 2
Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 4
Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 6
Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 8
Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 12
Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 16
Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 20
Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 26
Systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 1
Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 2
Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 4
Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 6
Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 8
Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 12
Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 16
Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 20
Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 26
Change from baseline in systolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 1
Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 2
Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 4
Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 6
Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 8
Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 12
Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 16
Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 20
Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 26
Diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 1
Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 2
Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 4
Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 6
Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 8
Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 12
Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 16
Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 20
Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 26
Change from baseline in diastolic blood pressure (mm Hg)
Pulse at Week 1
Pulse (beats per minute)
Pulse at Week 2
Pulse (beats per minute)
Pulse at Week 4
Pulse (beats per minute)
Pulse at Week 6
Pulse (beats per minute)
Pulse at Week 8
Pulse (beats per minute)
Pulse at Week 12
Pulse (beats per minute)
Pulse at Week 16
Pulse (beats per minute)
Pulse at Week 20
Pulse (beats per minute)
Pulse at Week 26
Pulse (beats per minute)
Change From Baseline in Pulse at Week 1
Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 2
Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 4
Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 6
Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 8
Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 12
Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 16
Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 20
Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 26
Change from baseline in pulse (beats per minute)
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change From Baseline in Body Weight at Week 6
Change from baseline in body weight
Change From Baseline in Body Weight at Week 12
Change from baseline in body weight
Change From Baseline in Body Weight at Week 26
Change from baseline in body weight
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
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
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
Full Information
NCT ID
NCT02355665
First Posted
January 30, 2015
Last Updated
December 18, 2018
Sponsor
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Collaborators
GlaxoSmithKline, McNeil AB
1. Study Identification
Unique Protocol Identification Number
NCT02355665
Brief Title
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 31, 2015 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
February 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Collaborators
GlaxoSmithKline, McNeil AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine
Arm Type
Experimental
Arm Description
Nicotine Spray
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match Nicotine spray
Intervention Type
Drug
Intervention Name(s)
Nicotine Spray
Intervention Description
Nicotine Spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match nicotine spray
Primary Outcome Measure Information:
Title
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6
Description
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time Frame
Week 2 to Week 6
Secondary Outcome Measure Information:
Title
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12
Description
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time Frame
Week 2 to Week 12
Title
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26
Description
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time Frame
Week 2 to Week 26
Title
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4
Description
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time Frame
Week 2 to Week 4
Title
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8
Description
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time Frame
Week 2 to Week 8
Title
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16
Description
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time Frame
Week 2 to Week 16
Title
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20
Description
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Time Frame
Week 2 to Week 20
Title
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
Description
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
Title
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
Description
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
Title
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
Description
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
Title
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
Description
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
Title
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
Description
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
Title
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
Description
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
Title
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
Description
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
Title
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
Description
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
Title
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
Description
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
Title
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
Description
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
Title
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
Description
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
Title
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
Description
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
Title
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
Description
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
Title
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
Description
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
Title
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
Description
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
Title
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
Description
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
Title
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
Description
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
Title
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
Description
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
Title
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
Description
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
Title
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
Description
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
Title
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
Description
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
Title
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
Description
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
Title
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
Description
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
Title
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
Description
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
Title
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
Description
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
Title
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
Description
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
Title
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
Description
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
Title
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
Description
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
Title
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
Description
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
Title
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
Description
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
Title
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
Description
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
Title
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
Description
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
Title
Aggregated Withdrawal Score at Week 1
Description
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
Title
Aggregated Withdrawal Score at Week 2
Description
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
Title
Aggregated Withdrawal Score at Week 4
Description
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
Title
Aggregated Withdrawal Score at Week 6
Description
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
Title
Total Daily Number of Self-Reported Spray Doses at Week 1
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 1
Title
Total Daily Number of Self-Reported Spray Doses at Week 2
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 2
Title
Total Daily Number of Self-Reported Spray Doses at Week 3
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 3
Title
Total Daily Number of Self-Reported Spray Doses at Week 4
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 4
Title
Total Daily Number of Self-Reported Spray Doses at Week 5
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 5
Title
Total Daily Number of Self-Reported Spray Doses at Week 6
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 6
Title
Total Daily Number of Self-Reported Spray Doses at Week 7
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 7
Title
Total Daily Number of Self-Reported Spray Doses at Week 8
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 8
Title
Total Daily Number of Self-Reported Spray Doses at Week 9
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 9
Title
Total Daily Number of Self-Reported Spray Doses at Week 10
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 10
Title
Total Daily Number of Self-Reported Spray Doses at Week 11
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 11
Title
Total Daily Number of Self-Reported Spray Doses at Week 12
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 12
Title
Total Daily Number of Self-Reported Spray Doses at Week 13
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 13
Title
Total Daily Number of Self-Reported Spray Doses at Week 14
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 14
Title
Total Daily Number of Self-Reported Spray Doses at Week 15
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 15
Title
Total Daily Number of Self-Reported Spray Doses at Week 16
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 16
Title
Total Daily Number of Self-Reported Spray Doses at Week 17
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 17
Title
Total Daily Number of Self-Reported Spray Doses at Week 18
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 18
Title
Total Daily Number of Self-Reported Spray Doses at Week 19
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 19
Title
Total Daily Number of Self-Reported Spray Doses at Week 20
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 20
Title
Total Daily Number of Self-Reported Spray Doses at Week 21
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 21
Title
Total Daily Number of Self-Reported Spray Doses at Week 22
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 22
Title
Total Daily Number of Self-Reported Spray Doses at Week 23
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 23
Title
Total Daily Number of Self-Reported Spray Doses at Week 24
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 24
Title
Total Daily Number of Self-Reported Spray Doses at Week 25
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 25
Title
Total Daily Number of Self-Reported Spray Doses at Week 26
Description
Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 26
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 1
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 1
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 2
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 2
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 3
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 3
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 4
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 4
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 5
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 5
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 6
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 6
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 7
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 7
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 8
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 8
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 9
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 9
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 10
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 10
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 11
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 11
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 12
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 12
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 13
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 13
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 14
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 14
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 15
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 15
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 16
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 16
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 17
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 17
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 18
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 18
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 19
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 19
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 20
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 20
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 21
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 21
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 22
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 22
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 23
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 23
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 24
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 24
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 25
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 25
Title
Maximum Total Daily Number of Self-Reported Spray Doses at Week 26
Description
Maximum Total Daily Number of Self-Reported Spray Doses
Time Frame
Week 26
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 1
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 1
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 2
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 2
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 3
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 3
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 4
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 4
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 5
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 5
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 6
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 6
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 7
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 7
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 8
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 8
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 9
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 9
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 10
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 10
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 11
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 11
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 12
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 12
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 13
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 13
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 14
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 14
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 15
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 15
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 16
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 16
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 17
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 17
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 18
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 18
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 19
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 19
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 20
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 20
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 21
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 21
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 22
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 22
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 23
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 23
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 24
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 24
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 25
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 25
Title
Maximum Hourly Number of Self-Reported Spray Doses at Week 26
Description
Maximum Hourly Number of Self-Reported Spray Doses
Time Frame
Week 26
Title
Number of Cigarettes Smoked Since Last Visit at Week 1
Description
Number of Cigarettes Smoked Since Last Visit
Time Frame
Week 1
Title
Number of Cigarettes Smoked Since Last Visit at Week 2
Description
Number of Cigarettes Smoked Since Last Visit
Time Frame
Week 2
Title
Number of Cigarettes Smoked Per Day at Week 4
Description
Number of Cigarettes Smoked Per Day
Time Frame
Week 4
Title
Number of Cigarettes Smoked Per Day at Week 6
Description
Number of Cigarettes Smoked Per Day
Time Frame
Week 6
Title
Number of Cigarettes Smoked Per Day at Week 8
Description
Number of Cigarettes Smoked Per Day
Time Frame
Week 8
Title
Number of Cigarettes Smoked Per Day at Week 12
Description
Number of Cigarettes Smoked Per Day
Time Frame
Week 12
Title
Number of Cigarettes Smoked Per Day at Week 16
Description
Number of Cigarettes Smoked Per Day
Time Frame
Week 16
Title
Number of Cigarettes Smoked Per Day at Week 20
Description
Number of Cigarettes Smoked Per Day
Time Frame
Week 20
Title
Number of Cigarettes Smoked Per Day at Week 26
Description
Number of Cigarettes Smoked Per Day
Time Frame
Week 26
Title
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
Description
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
Title
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
Description
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
Title
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
Description
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
Title
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1
Description
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
Title
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6
Description
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
Title
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12
Description
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
Title
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
Description
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
Title
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
Description
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
Title
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
Description
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
Title
Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product
Description
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
Title
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product
Description
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
Title
Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product
Description
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
Title
Percentage Distribution of the Participant Score for Product Convenience at Week 1
Description
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
Title
Percentage Distribution of the Participant Score for Product Convenience at Week 6
Description
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
Title
Percentage Distribution of the Participant Score for Product Convenience at Week 12
Description
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
Title
Systolic Blood Pressure at Week 1
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 1
Title
Systolic Blood Pressure at Week 2
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 2
Title
Systolic Blood Pressure at Week 4
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 4
Title
Systolic Blood Pressure at Week 6
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 6
Title
Systolic Blood Pressure at Week 8
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 8
Title
Systolic Blood Pressure at Week 12
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 12
Title
Systolic Blood Pressure at Week 16
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 16
Title
Systolic Blood Pressure at Week 20
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 20
Title
Systolic Blood Pressure at Week 26
Description
Systolic blood pressure (mm Hg)
Time Frame
Week 26
Title
Change From Baseline in Systolic Blood Pressure at Week 1
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 1
Title
Change From Baseline in Systolic Blood Pressure at Week 2
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 2
Title
Change From Baseline in Systolic Blood Pressure at Week 4
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 4
Title
Change From Baseline in Systolic Blood Pressure at Week 6
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 6
Title
Change From Baseline in Systolic Blood Pressure at Week 8
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 8
Title
Change From Baseline in Systolic Blood Pressure at Week 12
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 12
Title
Change From Baseline in Systolic Blood Pressure at Week 16
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 16
Title
Change From Baseline in Systolic Blood Pressure at Week 20
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 20
Title
Change From Baseline in Systolic Blood Pressure at Week 26
Description
Change from baseline in systolic blood pressure (mm Hg)
Time Frame
Baseline to Week 26
Title
Diastolic Blood Pressure at Week 1
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 1
Title
Diastolic Blood Pressure at Week 2
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 2
Title
Diastolic Blood Pressure at Week 4
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 4
Title
Diastolic Blood Pressure at Week 6
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 6
Title
Diastolic Blood Pressure at Week 8
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 8
Title
Diastolic Blood Pressure at Week 12
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 12
Title
Diastolic Blood Pressure at Week 16
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 16
Title
Diastolic Blood Pressure at Week 20
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 20
Title
Diastolic Blood Pressure at Week 26
Description
Diastolic blood pressure (mm Hg)
Time Frame
Week 26
Title
Change From Baseline in Diastolic Blood Pressure at Week 1
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 1
Title
Change From Baseline in Diastolic Blood Pressure at Week 2
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 2
Title
Change From Baseline in Diastolic Blood Pressure at Week 4
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 4
Title
Change From Baseline in Diastolic Blood Pressure at Week 6
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 6
Title
Change From Baseline in Diastolic Blood Pressure at Week 8
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 8
Title
Change From Baseline in Diastolic Blood Pressure at Week 12
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 12
Title
Change From Baseline in Diastolic Blood Pressure at Week 16
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 16
Title
Change From Baseline in Diastolic Blood Pressure at Week 20
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 20
Title
Change From Baseline in Diastolic Blood Pressure at Week 26
Description
Change from baseline in diastolic blood pressure (mm Hg)
Time Frame
Baseline to Week 26
Title
Pulse at Week 1
Description
Pulse (beats per minute)
Time Frame
Week 1
Title
Pulse at Week 2
Description
Pulse (beats per minute)
Time Frame
Week 2
Title
Pulse at Week 4
Description
Pulse (beats per minute)
Time Frame
Week 4
Title
Pulse at Week 6
Description
Pulse (beats per minute)
Time Frame
Week 6
Title
Pulse at Week 8
Description
Pulse (beats per minute)
Time Frame
Week 8
Title
Pulse at Week 12
Description
Pulse (beats per minute)
Time Frame
Week 12
Title
Pulse at Week 16
Description
Pulse (beats per minute)
Time Frame
Week 16
Title
Pulse at Week 20
Description
Pulse (beats per minute)
Time Frame
Week 20
Title
Pulse at Week 26
Description
Pulse (beats per minute)
Time Frame
Week 26
Title
Change From Baseline in Pulse at Week 1
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 1
Title
Change From Baseline in Pulse at Week 2
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 2
Title
Change From Baseline in Pulse at Week 4
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 4
Title
Change From Baseline in Pulse at Week 6
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 6
Title
Change From Baseline in Pulse at Week 8
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 8
Title
Change From Baseline in Pulse at Week 12
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 12
Title
Change From Baseline in Pulse at Week 16
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 16
Title
Change From Baseline in Pulse at Week 20
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 20
Title
Change From Baseline in Pulse at Week 26
Description
Change from baseline in pulse (beats per minute)
Time Frame
Baseline to Week 26
Title
Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study
Description
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
Title
Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study
Description
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
Title
Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study
Description
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
Title
Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study
Description
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
Title
Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study
Description
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
Title
Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study
Description
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
Title
Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study
Description
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
Title
Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study
Description
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
Title
Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study
Description
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
Title
Change From Baseline in Body Weight at Week 6
Description
Change from baseline in body weight
Time Frame
Baseline to Week 6
Title
Change From Baseline in Body Weight at Week 12
Description
Change from baseline in body weight
Time Frame
Baseline to Week 12
Title
Change From Baseline in Body Weight at Week 26
Description
Change from baseline in body weight
Time Frame
Baseline to Week 26
Title
Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
Description
Change from baseline in body weight
Time Frame
Baseline to Week 6
Title
Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
Description
Change from baseline in body weight
Time Frame
Baseline to Week 12
Title
Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
Description
Change from baseline in body weight
Time Frame
Baseline to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Myers, MD
Organizational Affiliation
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Los Angeles Clinical Trials
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Radiant Research, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Facility Name
Radiant Research, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Radiant Research, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Radiant Research, Inc
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30452732
Citation
Nides M, Danielsson T, Saunders F, Perfekt R, Kapikian R, Solla J, Leischow SJ, Myers A. Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A Randomized, Multicenter, Controlled Study in a Naturalistic Setting. Nicotine Tob Res. 2020 Mar 16;22(3):339-345. doi: 10.1093/ntr/nty246.
Results Reference
derived
Learn more about this trial
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
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