Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
- Registration Number
- NCT02355665
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1198
Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nicotine Nicotine Spray Nicotine Spray Placebo Placebo Placebo to match Nicotine spray
- Primary Outcome Measures
Name Time Method Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 Week 2 to Week 6 Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
- Secondary Outcome Measures
Name Time Method Change From Baseline in Systolic Blood Pressure at Week 8 Baseline to Week 8 Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 20 Baseline to Week 20 Change from baseline in systolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 1 Week 1 Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 2 Week 2 Diastolic blood pressure (mm Hg)
Pulse at Week 20 Week 20 Pulse (beats per minute)
Change From Baseline in Diastolic Blood Pressure at Week 12 Baseline to Week 12 Change from baseline in diastolic blood pressure (mm Hg)
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6 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 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).
Total Daily Number of Self-Reported Spray Doses at Week 12 Week 12 Total Daily Number of Self-Reported Spray Doses
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2 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 Increased Appetite on a Categorical Scale at Week 2 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 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 Desire/Urge to Smoke on a Categorical Scale at Week 2 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 Irritability/Frustration/Anger on a Categorical Scale at Week 4 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 Restlessness on a Categorical Scale at Week 6 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 4 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).
Maximum Hourly Number of Self-Reported Spray Doses at Week 1 Week 1 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 5 Week 5 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 11 Week 11 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 15 Week 15 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 16 Week 16 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 21 Week 21 Maximum Hourly Number of Self-Reported Spray Doses
Number of Cigarettes Smoked Since Last Visit at Week 2 Week 2 Number of Cigarettes Smoked Since Last Visit
Maximum Total Daily Number of Self-Reported Spray Doses at Week 11 Week 11 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 16 Week 16 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 17 Week 17 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 19 Week 19 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 20 Week 20 Maximum Total Daily Number of Self-Reported Spray Doses
Number of Cigarettes Smoked Per Day at Week 12 Week 12 Number of Cigarettes Smoked Per Day
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12 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 Week 2 to Week 26 Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6 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 of Participants With Continuous Smoking Abstinence From Week 2 to Week 4 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 16 Week 2 to Week 16 Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2 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).
Total Daily Number of Self-Reported Spray Doses at Week 13 Week 13 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 15 Week 15 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 20 Week 20 Total Daily Number of Self-Reported Spray Doses
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1 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 4 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 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 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 Anxiety on a Categorical Scale at Week 2 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 of Participants With Continuous Smoking Abstinence From Week 2 to Week 20 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 Irritability/Frustration/Anger on a Categorical Scale at Week 2 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 Restlessness on a Categorical Scale at Week 1 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 Anxiety on a Categorical Scale at Week 1 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 4 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 Insomnia on a Categorical Scale at Week 4 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 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).
Maximum Total Daily Number of Self-Reported Spray Doses at Week 5 Week 5 Maximum Total Daily Number of Self-Reported Spray Doses
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8 Week 2 to Week 8 Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1 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 Increased Appetite on a Categorical Scale at Week 1 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).
Total Daily Number of Self-Reported Spray Doses at Week 1 Week 1 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 5 Week 5 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 6 Week 6 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 9 Week 9 Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 6 Week 6 Maximum Total Daily Number of Self-Reported Spray Doses
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2 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 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).
Maximum Total Daily Number of Self-Reported Spray Doses at Week 7 Week 7 Maximum Total Daily Number of Self-Reported Spray Doses
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1 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 6 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 Dysphoric or Depressed Mood on a Categorical Scale at Week 4 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 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).
Aggregated Withdrawal Score at Week 4 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.
Maximum Total Daily Number of Self-Reported Spray Doses at Week 10 Week 10 Maximum Total Daily Number of Self-Reported Spray Doses
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2 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).
Aggregated Withdrawal Score at Week 1 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.
Total Daily Number of Self-Reported Spray Doses at Week 7 Week 7 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 17 Week 17 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 18 Week 18 Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 3 Week 3 Maximum Total Daily Number of Self-Reported Spray Doses
Aggregated Withdrawal Score at Week 2 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.
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6 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).
Total Daily Number of Self-Reported Spray Doses at Week 3 Week 3 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 4 Week 4 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 8 Week 8 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 10 Week 10 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 16 Week 16 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 19 Week 19 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 21 Week 21 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 22 Week 22 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 24 Week 24 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 25 Week 25 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 26 Week 26 Total Daily Number of Self-Reported Spray Doses
Aggregated Withdrawal Score at Week 6 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 2 Week 2 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 11 Week 11 Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 14 Week 14 Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 15 Week 15 Maximum Total Daily Number of Self-Reported Spray Doses
Total Daily Number of Self-Reported Spray Doses at Week 23 Week 23 Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 1 Week 1 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 2 Week 2 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 9 Week 9 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 12 Week 12 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 14 Week 14 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 23 Week 23 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 3 Week 3 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 6 Week 6 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 7 Week 7 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 12 Week 12 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 13 Week 13 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 8 Week 8 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 13 Week 13 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 18 Week 18 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 14 Week 14 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 23 Week 23 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 24 Week 24 Maximum Hourly Number of Self-Reported Spray Doses
Number of Cigarettes Smoked Per Day at Week 16 Week 16 Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day at Week 26 Week 26 Number of Cigarettes Smoked Per Day
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1 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).
Maximum Total Daily Number of Self-Reported Spray Doses at Week 4 Week 4 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 21 Week 21 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 24 Week 24 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 26 Week 26 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 4 Week 4 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 8 Week 8 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 9 Week 9 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 10 Week 10 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 17 Week 17 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 19 Week 19 Maximum Hourly Number of Self-Reported Spray Doses
Number of Cigarettes Smoked Since Last Visit at Week 1 Week 1 Number of Cigarettes Smoked Since Last Visit
Number of Cigarettes Smoked Per Day at Week 4 Week 4 Number of Cigarettes Smoked Per Day
Maximum Hourly Number of Self-Reported Spray Doses at Week 18 Week 18 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 20 Week 20 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 22 Week 22 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Total Daily Number of Self-Reported Spray Doses at Week 25 Week 25 Maximum Total Daily Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 2 Week 2 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 26 Week 26 Maximum Hourly Number of Self-Reported Spray Doses
Number of Cigarettes Smoked Per Day at Week 6 Week 6 Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day at Week 8 Week 8 Number of Cigarettes Smoked Per Day
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6 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).
Systolic Blood Pressure at Week 6 Week 6 Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 8 Week 8 Systolic blood pressure (mm Hg)
Maximum Hourly Number of Self-Reported Spray Doses at Week 22 Week 22 Maximum Hourly Number of Self-Reported Spray Doses
Maximum Hourly Number of Self-Reported Spray Doses at Week 25 Week 25 Maximum Hourly Number of Self-Reported Spray Doses
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12 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 12 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 Change of Opinion at Week 1 Concerning Product Compared to When First Used Product Week 1 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).
Number of Cigarettes Smoked Per Day at Week 20 Week 20 Number of Cigarettes Smoked Per Day
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6 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 Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1 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 Speed of Action of the Product at Week 12 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).
Systolic Blood Pressure at Week 1 Week 1 Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 20 Week 20 Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 26 Week 26 Systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 4 Baseline to Week 4 Change from baseline in systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 2 Week 2 Systolic blood pressure (mm Hg)
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6 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 Speed of Action of the Product at Week 1 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 Product Convenience at Week 6 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).
Change From Baseline in Systolic Blood Pressure at Week 1 Baseline to Week 1 Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 6 Baseline to Week 6 Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 12 Baseline to Week 12 Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 26 Baseline to Week 26 Change from baseline in systolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 6 Week 6 Diastolic blood pressure (mm Hg)
Change From Baseline in Pulse at Week 2 Baseline to Week 2 Change from baseline in pulse (beats per minute)
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product Week 6 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 of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study 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 Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product Week 12 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 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 12 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 4 Week 4 Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 12 Week 12 Systolic blood pressure (mm Hg)
Systolic Blood Pressure at Week 16 Week 16 Systolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 16 Week 16 Diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 6 Baseline to Week 6 Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 26 Baseline to Week 26 Change from baseline in diastolic blood pressure (mm Hg)
Pulse at Week 2 Week 2 Pulse (beats per minute)
Pulse at Week 4 Week 4 Pulse (beats per minute)
Pulse at Week 16 Week 16 Pulse (beats per minute)
Change From Baseline in Pulse at Week 1 Baseline to Week 1 Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 8 Baseline to Week 8 Change from baseline in pulse (beats per minute)
Change From Baseline in Systolic Blood Pressure at Week 2 Baseline to Week 2 Change from baseline in systolic blood pressure (mm Hg)
Change From Baseline in Systolic Blood Pressure at Week 16 Baseline to Week 16 Change from baseline in systolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 12 Week 12 Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 20 Week 20 Diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 4 Baseline to Week 4 Change from baseline in diastolic blood pressure (mm Hg)
Pulse at Week 8 Week 8 Pulse (beats per minute)
Pulse at Week 12 Week 12 Pulse (beats per minute)
Change From Baseline in Pulse at Week 12 Baseline to Week 12 Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 26 Baseline to Week 26 Change from baseline in pulse (beats per minute)
Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study 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 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 Diastolic Blood Pressure at Week 20 Baseline to Week 20 Change from baseline in diastolic blood pressure (mm Hg)
Pulse at Week 1 Week 1 Pulse (beats per minute)
Pulse at Week 6 Week 6 Pulse (beats per minute)
Diastolic Blood Pressure at Week 4 Week 4 Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 8 Week 8 Diastolic blood pressure (mm Hg)
Diastolic Blood Pressure at Week 26 Week 26 Diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 1 Baseline to Week 1 Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 2 Baseline to Week 2 Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 8 Baseline to Week 8 Change from baseline in diastolic blood pressure (mm Hg)
Change From Baseline in Diastolic Blood Pressure at Week 16 Baseline to Week 16 Change from baseline in diastolic blood pressure (mm Hg)
Pulse at Week 26 Week 26 Pulse (beats per minute)
Change From Baseline in Pulse at Week 4 Baseline to Week 4 Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 6 Baseline to Week 6 Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 16 Baseline to Week 16 Change from baseline in pulse (beats per minute)
Change From Baseline in Pulse at Week 20 Baseline to Week 20 Change from baseline in pulse (beats per minute)
Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study 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 12 Baseline to Week 12 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 Baseline to Week 6 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 Baseline to Week 12 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 Baseline to Week 26 Change from baseline in body weight
Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study 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 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 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 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 Baseline to Week 6 Change from baseline in body weight
Change From Baseline in Body Weight at Week 26 Baseline to Week 26 Change from baseline in body weight
Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study 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.
Trial Locations
- Locations (6)
Los Angeles Clinical Trials
🇺🇸Burbank, California, United States
Radiant Research, Inc
🇺🇸Salt Lake City, Utah, United States
University of Maryland
🇺🇸College Park, Maryland, United States
Radiant Research, Inc.
🇺🇸Akron, Ohio, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Radiant Research
🇺🇸Cincinnati, Ohio, United States