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

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

The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Nicotine Spray; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1198
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • California
    • Burbank, California, United States, 91505
      • Los Angeles Clinical Trials
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Radiant Research, Inc
  • Maryland
    • College Park, Maryland, United States, 20742
      • University of Maryland
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc.
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
  • Texas
    • Dallas, Texas, United States, 75231
      • Radiant Research, Inc
  • Utah
    • Salt Lake City, Utah, United States, 84123
      • Radiant Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nicotine; Nicotine Spray	Drug: Nicotine Spray; Nicotine Spray
Placebo Comparator: Placebo; Placebo to match Nicotine spray	Drug: Placebo; Placebo to match nicotine spray

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Collaborators: GlaxoSmithKline; McNeil AB
• Investigators: Study Director: Andrew Myers, MD, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2015
• Primary Completion (Actual): September 30, 2015
• Study Completion (Actual): February 10, 2016

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: CO-140121222102-SCCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED