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

Tobacco Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355665
• Other study ID #: CO-140121222102-SCCT
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2015
• Est. completion date: February 10, 2016

Study information

• Verified date: December 2018
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1198
• Est. completion date: February 10, 2016
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine Spray
Nicotine Spray
• Placebo
Placebo to match nicotine spray

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Akron	Ohio
United States	Los Angeles Clinical Trials	Burbank	California
United States	Radiant Research, Inc	Chicago	Illinois
United States	Radiant Research	Cincinnati	Ohio
United States	University of Maryland	College Park	Maryland
United States	Radiant Research, Inc	Dallas	Texas
United States	Radiant Research, Inc	Salt Lake City	Utah
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.	GlaxoSmithKline, McNeil AB

Country where clinical trial is conducted

United States, 

Outcome

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