Tobacco DependencePhase 3NCT02355665
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
A Phase 3 study testing Nicotine Spray in people with Tobacco Dependence, run by McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Nicotine Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,198 participants
- Where
- 8 sitesUnited States
- Study dates
- 31 Jan 2015to 10 Feb 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Radiant Research, Inc.
Akron, Ohio, 44311
Los Angeles Clinical Trials
Burbank, California, 91505
Radiant Research, Inc
Chicago, Illinois, 60654
Radiant Research
Cincinnati, Ohio, 45249
University of Maryland
College Park, Maryland, 20742
Radiant Research, Inc
Dallas, Texas, 75231
Radiant Research, Inc
Salt Lake City, Utah, 84123
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
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
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.
- Conditions
- Tobacco Dependence
- Being tested
- Nicotine Spray, Placebo
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine SprayDrug
Nicotine Spray
PlaceboDrug
Placebo to match nicotine spray
| Study group | Role | What they receive |
|---|---|---|
| Nicotine | Experimental | Nicotine Spray Receives: Drug: Nicotine Spray |
| Placebo | Placebo comparator | Placebo to match Nicotine spray Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 2 to Week 6
Secondary outcomes (213)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6
Total Daily Number of Self-Reported Spray Doses at Week 1
Total Daily Number of Self-Reported Spray Doses
Measured: Week 1
Total Daily Number of Self-Reported Spray Doses at Week 2
Total Daily Number of Self-Reported Spray Doses
Measured: Week 2
Total Daily Number of Self-Reported Spray Doses at Week 3
Total Daily Number of Self-Reported Spray Doses
Measured: Week 3
Total Daily Number of Self-Reported Spray Doses at Week 4
Total Daily Number of Self-Reported Spray Doses
Measured: Week 4
Total Daily Number of Self-Reported Spray Doses at Week 5
Total Daily Number of Self-Reported Spray Doses
Measured: Week 5
Total Daily Number of Self-Reported Spray Doses at Week 6
Total Daily Number of Self-Reported Spray Doses
Measured: Week 6
Total Daily Number of Self-Reported Spray Doses at Week 7
Total Daily Number of Self-Reported Spray Doses
Measured: Week 7
Total Daily Number of Self-Reported Spray Doses at Week 8
Total Daily Number of Self-Reported Spray Doses
Measured: Week 8
Total Daily Number of Self-Reported Spray Doses at Week 9
Total Daily Number of Self-Reported Spray Doses
Measured: Week 9
Total Daily Number of Self-Reported Spray Doses at Week 10
Total Daily Number of Self-Reported Spray Doses
Measured: Week 10
Total Daily Number of Self-Reported Spray Doses at Week 11
Total Daily Number of Self-Reported Spray Doses
Measured: Week 11
Total Daily Number of Self-Reported Spray Doses at Week 12
Total Daily Number of Self-Reported Spray Doses
Measured: Week 12
Total Daily Number of Self-Reported Spray Doses at Week 13
Total Daily Number of Self-Reported Spray Doses
Measured: Week 13
Total Daily Number of Self-Reported Spray Doses at Week 14
Total Daily Number of Self-Reported Spray Doses
Measured: Week 14
Total Daily Number of Self-Reported Spray Doses at Week 15
Total Daily Number of Self-Reported Spray Doses
Measured: Week 15
Total Daily Number of Self-Reported Spray Doses at Week 16
Total Daily Number of Self-Reported Spray Doses
Measured: Week 16
Total Daily Number of Self-Reported Spray Doses at Week 17
Total Daily Number of Self-Reported Spray Doses
Measured: Week 17
Total Daily Number of Self-Reported Spray Doses at Week 18
Total Daily Number of Self-Reported Spray Doses
Measured: Week 18
Total Daily Number of Self-Reported Spray Doses at Week 19
Total Daily Number of Self-Reported Spray Doses
Measured: Week 19
Total Daily Number of Self-Reported Spray Doses at Week 20
Total Daily Number of Self-Reported Spray Doses
Measured: Week 20
Total Daily Number of Self-Reported Spray Doses at Week 21
Total Daily Number of Self-Reported Spray Doses
Measured: Week 21
Total Daily Number of Self-Reported Spray Doses at Week 22
Total Daily Number of Self-Reported Spray Doses
Measured: Week 22
Total Daily Number of Self-Reported Spray Doses at Week 23
Total Daily Number of Self-Reported Spray Doses
Measured: Week 23
Total Daily Number of Self-Reported Spray Doses at Week 24
Total Daily Number of Self-Reported Spray Doses
Measured: Week 24
Total Daily Number of Self-Reported Spray Doses at Week 25
Total Daily Number of Self-Reported Spray Doses
Measured: Week 25
Total Daily Number of Self-Reported Spray Doses at Week 26
Total Daily Number of Self-Reported Spray Doses
Measured: Week 26
Maximum Total Daily Number of Self-Reported Spray Doses at Week 1
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 1
Maximum Total Daily Number of Self-Reported Spray Doses at Week 2
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 2
Maximum Total Daily Number of Self-Reported Spray Doses at Week 3
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 3
Maximum Total Daily Number of Self-Reported Spray Doses at Week 4
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 4
Maximum Total Daily Number of Self-Reported Spray Doses at Week 5
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 5
Maximum Total Daily Number of Self-Reported Spray Doses at Week 6
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 6
Maximum Total Daily Number of Self-Reported Spray Doses at Week 7
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 7
Maximum Total Daily Number of Self-Reported Spray Doses at Week 8
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 8
Maximum Total Daily Number of Self-Reported Spray Doses at Week 9
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 9
Maximum Total Daily Number of Self-Reported Spray Doses at Week 10
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 10
Maximum Total Daily Number of Self-Reported Spray Doses at Week 11
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 11
Maximum Total Daily Number of Self-Reported Spray Doses at Week 12
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 12
Maximum Total Daily Number of Self-Reported Spray Doses at Week 13
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 13
Maximum Total Daily Number of Self-Reported Spray Doses at Week 14
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 14
Maximum Total Daily Number of Self-Reported Spray Doses at Week 15
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 15
Maximum Total Daily Number of Self-Reported Spray Doses at Week 16
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 16
Maximum Total Daily Number of Self-Reported Spray Doses at Week 17
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 17
Maximum Total Daily Number of Self-Reported Spray Doses at Week 18
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 18
Maximum Total Daily Number of Self-Reported Spray Doses at Week 19
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 19
Maximum Total Daily Number of Self-Reported Spray Doses at Week 20
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 20
Maximum Total Daily Number of Self-Reported Spray Doses at Week 21
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 21
Maximum Total Daily Number of Self-Reported Spray Doses at Week 22
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 22
Maximum Total Daily Number of Self-Reported Spray Doses at Week 23
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 23
Maximum Total Daily Number of Self-Reported Spray Doses at Week 24
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 24
Maximum Total Daily Number of Self-Reported Spray Doses at Week 25
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 25
Maximum Total Daily Number of Self-Reported Spray Doses at Week 26
Maximum Total Daily Number of Self-Reported Spray Doses
Measured: Week 26
Maximum Hourly Number of Self-Reported Spray Doses at Week 1
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 1
Maximum Hourly Number of Self-Reported Spray Doses at Week 2
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 2
Maximum Hourly Number of Self-Reported Spray Doses at Week 3
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 3
Maximum Hourly Number of Self-Reported Spray Doses at Week 4
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 4
Maximum Hourly Number of Self-Reported Spray Doses at Week 5
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 5
Maximum Hourly Number of Self-Reported Spray Doses at Week 6
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 6
Maximum Hourly Number of Self-Reported Spray Doses at Week 7
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 7
Maximum Hourly Number of Self-Reported Spray Doses at Week 8
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 8
Maximum Hourly Number of Self-Reported Spray Doses at Week 9
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 9
Maximum Hourly Number of Self-Reported Spray Doses at Week 10
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 10
Maximum Hourly Number of Self-Reported Spray Doses at Week 11
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 11
Maximum Hourly Number of Self-Reported Spray Doses at Week 12
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 12
Maximum Hourly Number of Self-Reported Spray Doses at Week 13
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 13
Maximum Hourly Number of Self-Reported Spray Doses at Week 14
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 14
Maximum Hourly Number of Self-Reported Spray Doses at Week 15
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 15
Maximum Hourly Number of Self-Reported Spray Doses at Week 16
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 16
Maximum Hourly Number of Self-Reported Spray Doses at Week 17
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 17
Maximum Hourly Number of Self-Reported Spray Doses at Week 18
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 18
Maximum Hourly Number of Self-Reported Spray Doses at Week 19
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 19
Maximum Hourly Number of Self-Reported Spray Doses at Week 20
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 20
Maximum Hourly Number of Self-Reported Spray Doses at Week 21
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 21
Maximum Hourly Number of Self-Reported Spray Doses at Week 22
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 22
Maximum Hourly Number of Self-Reported Spray Doses at Week 23
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 23
Maximum Hourly Number of Self-Reported Spray Doses at Week 24
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 24
Maximum Hourly Number of Self-Reported Spray Doses at Week 25
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 25
Maximum Hourly Number of Self-Reported Spray Doses at Week 26
Maximum Hourly Number of Self-Reported Spray Doses
Measured: Week 26
Number of Cigarettes Smoked Since Last Visit at Week 1
Number of Cigarettes Smoked Since Last Visit
Measured: Week 1
Number of Cigarettes Smoked Since Last Visit at Week 2
Number of Cigarettes Smoked Since Last Visit
Measured: Week 2
Number of Cigarettes Smoked Per Day at Week 4
Number of Cigarettes Smoked Per Day
Measured: Week 4
Number of Cigarettes Smoked Per Day at Week 6
Number of Cigarettes Smoked Per Day
Measured: Week 6
Number of Cigarettes Smoked Per Day at Week 8
Number of Cigarettes Smoked Per Day
Measured: Week 8
Number of Cigarettes Smoked Per Day at Week 12
Number of Cigarettes Smoked Per Day
Measured: Week 12
Number of Cigarettes Smoked Per Day at Week 16
Number of Cigarettes Smoked Per Day
Measured: Week 16
Number of Cigarettes Smoked Per Day at Week 20
Number of Cigarettes Smoked Per Day
Measured: Week 20
Number of Cigarettes Smoked Per Day at Week 26
Number of Cigarettes Smoked Per Day
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 12
Systolic Blood Pressure at Week 1
Systolic blood pressure (mm Hg)
Measured: Week 1
Systolic Blood Pressure at Week 2
Systolic blood pressure (mm Hg)
Measured: Week 2
Systolic Blood Pressure at Week 4
Systolic blood pressure (mm Hg)
Measured: Week 4
Systolic Blood Pressure at Week 6
Systolic blood pressure (mm Hg)
Measured: Week 6
Systolic Blood Pressure at Week 8
Systolic blood pressure (mm Hg)
Measured: Week 8
Systolic Blood Pressure at Week 12
Systolic blood pressure (mm Hg)
Measured: Week 12
Systolic Blood Pressure at Week 16
Systolic blood pressure (mm Hg)
Measured: Week 16
Systolic Blood Pressure at Week 20
Systolic blood pressure (mm Hg)
Measured: Week 20
Systolic Blood Pressure at Week 26
Systolic blood pressure (mm Hg)
Measured: Week 26
Change From Baseline in Systolic Blood Pressure at Week 1
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 1
Change From Baseline in Systolic Blood Pressure at Week 2
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 2
Change From Baseline in Systolic Blood Pressure at Week 4
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 4
Change From Baseline in Systolic Blood Pressure at Week 6
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 6
Change From Baseline in Systolic Blood Pressure at Week 8
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 8
Change From Baseline in Systolic Blood Pressure at Week 12
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 12
Change From Baseline in Systolic Blood Pressure at Week 16
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 16
Change From Baseline in Systolic Blood Pressure at Week 20
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 20
Change From Baseline in Systolic Blood Pressure at Week 26
Change from baseline in systolic blood pressure (mm Hg)
Measured: Baseline to Week 26
Diastolic Blood Pressure at Week 1
Diastolic blood pressure (mm Hg)
Measured: Week 1
Diastolic Blood Pressure at Week 2
Diastolic blood pressure (mm Hg)
Measured: Week 2
Diastolic Blood Pressure at Week 4
Diastolic blood pressure (mm Hg)
Measured: Week 4
Diastolic Blood Pressure at Week 6
Diastolic blood pressure (mm Hg)
Measured: Week 6
Diastolic Blood Pressure at Week 8
Diastolic blood pressure (mm Hg)
Measured: Week 8
Diastolic Blood Pressure at Week 12
Diastolic blood pressure (mm Hg)
Measured: Week 12
Diastolic Blood Pressure at Week 16
Diastolic blood pressure (mm Hg)
Measured: Week 16
Diastolic Blood Pressure at Week 20
Diastolic blood pressure (mm Hg)
Measured: Week 20
Diastolic Blood Pressure at Week 26
Diastolic blood pressure (mm Hg)
Measured: Week 26
Change From Baseline in Diastolic Blood Pressure at Week 1
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 1
Change From Baseline in Diastolic Blood Pressure at Week 2
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 2
Change From Baseline in Diastolic Blood Pressure at Week 4
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 4
Change From Baseline in Diastolic Blood Pressure at Week 6
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 6
Change From Baseline in Diastolic Blood Pressure at Week 8
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 8
Change From Baseline in Diastolic Blood Pressure at Week 12
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 12
Change From Baseline in Diastolic Blood Pressure at Week 16
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 16
Change From Baseline in Diastolic Blood Pressure at Week 20
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 20
Change From Baseline in Diastolic Blood Pressure at Week 26
Change from baseline in diastolic blood pressure (mm Hg)
Measured: Baseline to Week 26
Pulse at Week 1
Pulse (beats per minute)
Measured: Week 1
Pulse at Week 2
Pulse (beats per minute)
Measured: Week 2
Pulse at Week 4
Pulse (beats per minute)
Measured: Week 4
Pulse at Week 6
Pulse (beats per minute)
Measured: Week 6
Pulse at Week 8
Pulse (beats per minute)
Measured: Week 8
Pulse at Week 12
Pulse (beats per minute)
Measured: Week 12
Pulse at Week 16
Pulse (beats per minute)
Measured: Week 16
Pulse at Week 20
Pulse (beats per minute)
Measured: Week 20
Pulse at Week 26
Pulse (beats per minute)
Measured: Week 26
Change From Baseline in Pulse at Week 1
Change from baseline in pulse (beats per minute)
Measured: Baseline to Week 1
Change From Baseline in Pulse at Week 2
Change from baseline in pulse (beats per minute)
Measured: Baseline to Week 2
Change From Baseline in Pulse at Week 4
Change from baseline in pulse (beats per minute)
Measured: Baseline to Week 4
Change From Baseline in Pulse at Week 6
Change from baseline in pulse (beats per minute)
Measured: Baseline to Week 6
Change From Baseline in Pulse at Week 8
Change from baseline in pulse (beats per minute)
Measured: Baseline to Week 8
Change From Baseline in Pulse at Week 12
Change from baseline in pulse (beats per minute)
Measured: Baseline to Week 12
Change From Baseline in Pulse at Week 16
Change from baseline in pulse (beats per minute)
Measured: Baseline to Week 16
Change From Baseline in Pulse at Week 20
Change from baseline in pulse (beats per minute)
Measured: Baseline to Week 20
Change From Baseline in Pulse at Week 26
Change from baseline in pulse (beats per minute)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 or when withdrawn from study
Change From Baseline in Body Weight at Week 6
Change from baseline in body weight
Measured: Baseline to Week 6
Change From Baseline in Body Weight at Week 12
Change from baseline in body weight
Measured: Baseline to Week 12
Change From Baseline in Body Weight at Week 26
Change from baseline in body weight
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study start31 Jan 2015
- Primary completion30 Sep 2015
- Study completion10 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,198 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, McNeil AB
- Responsible party
- Sponsor
- Investigators
- Andrew Myers, MD, Study director, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355665
- Sponsor's protocol ID
- CO-140121222102-SCCT
- Status last verified
- Dec 2018
- First submitted
- 30 Jan 2015
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 30452732
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02355665
- Acronym / sponsor ID
- CO-140121222102-SCCT
- Conditions
- Tobacco Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,198 participants (actual)
- Lead sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, McNeil AB
- Study start
- 31 Jan 2015 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 10 Feb 2016 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine | Experimental | Drug: Nicotine SprayNicotine Spray |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match Nicotine spray |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine SprayNicotine Spray | Drug | Nicotine |
| PlaceboPlacebo to match nicotine spray | Drug | Placebo |
Primary outcome
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6
Time frame: Week 2 to Week 6
Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking
213 secondary outcomes
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12
Time frame: Week 2 to Week 12
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26
Time frame: Week 2 to Week 26
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4
Time frame: Week 2 to Week 4
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8
Time frame: Week 2 to Week 8
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16
Time frame: Week 2 to Week 16
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20
Time frame: Week 2 to Week 20
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
Time frame: Week 1
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
Time frame: Week 2
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
Time frame: Week 4
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
Time frame: Week 6
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
Time frame: Week 1
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
Time frame: Week 2
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
Time frame: Week 4
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
Time frame: Week 6
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
Time frame: Week 1
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
Time frame: Week 2
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
Time frame: Week 4
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
Time frame: Week 6
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
Time frame: Week 1
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
Time frame: Week 2
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
Time frame: Week 4
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
Time frame: Week 6
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
Time frame: Week 1
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
Time frame: Week 2
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
Time frame: Week 4
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
Time frame: Week 6
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
Time frame: Week 1
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
Time frame: Week 2
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
Time frame: Week 4
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
Time frame: Week 6
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
Time frame: Week 1
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
Time frame: Week 2
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
Time frame: Week 4
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
Time frame: Week 6
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
Time frame: Week 1
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
Time frame: Week 2
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
Time frame: Week 4
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
Time frame: Week 6
Aggregated Withdrawal Score at Week 1
Time frame: Week 1
Aggregated Withdrawal Score at Week 2
Time frame: Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30452732Nides 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Myers, MD study director
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotine Spray in people with Tobacco Dependence, run by McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6 (time frame: Week 2 to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.