Clinical trial NCT02355665: Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Using a Naturalistic Clinical Model to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers Motivated to Quit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Dependence
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
name: McNeil AB
First posted: 2015-02-04
Enrollment: 1198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking

Exclusion Criteria:

History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.

Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.

Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.

Pregnancy or intending to become pregnant.

Hypersensitivity to the product, history of alcohol or substance abuse.

Primary outcomes:
measure: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6
timeFrame: Week 2 to Week 6
Secondary outcomes:
measure: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12
timeFrame: Week 2 to Week 12
measure: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26
timeFrame: Week 2 to Week 26
measure: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4
timeFrame: Week 2 to Week 4
measure: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8
timeFrame: Week 2 to Week 8
measure: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16
timeFrame: Week 2 to Week 16
measure: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20
timeFrame: Week 2 to Week 20
measure: Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2
timeFrame: Week 2
measure: Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4
timeFrame: Week 4
measure: Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2
timeFrame: Week 2
measure: Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4
timeFrame: Week 4
measure: Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2
timeFrame: Week 2
measure: Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4
timeFrame: Week 4
measure: Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2
timeFrame: Week 2
measure: Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4
timeFrame: Week 4
measure: Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2
timeFrame: Week 2
measure: Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4
timeFrame: Week 4
measure: Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2
timeFrame: Week 2
measure: Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4
timeFrame: Week 4
measure: Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2
timeFrame: Week 2
measure: Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4
timeFrame: Week 4
measure: Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2
timeFrame: Week 2
measure: Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4
timeFrame: Week 4
measure: Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6
timeFrame: Week 6
measure: Aggregated Withdrawal Score at Week 1
timeFrame: Week 1
measure: Aggregated Withdrawal Score at Week 2
timeFrame: Week 2
measure: Aggregated Withdrawal Score at Week 4
timeFrame: Week 4
measure: Aggregated Withdrawal Score at Week 6
timeFrame: Week 6
measure: Total Daily Number of Self-Reported Spray Doses at Week 1
timeFrame: Week 1
measure: Total Daily Number of Self-Reported Spray Doses at Week 2
timeFrame: Week 2
measure: Total Daily Number of Self-Reported Spray Doses at Week 3
timeFrame: Week 3
measure: Total Daily Number of Self-Reported Spray Doses at Week 4
timeFrame: Week 4
measure: Total Daily Number of Self-Reported Spray Doses at Week 5
timeFrame: Week 5
measure: Total Daily Number of Self-Reported Spray Doses at Week 6
timeFrame: Week 6
measure: Total Daily Number of Self-Reported Spray Doses at Week 7
timeFrame: Week 7
measure: Total Daily Number of Self-Reported Spray Doses at Week 8
timeFrame: Week 8
measure: Total Daily Number of Self-Reported Spray Doses at Week 9
timeFrame: Week 9
measure: Total Daily Number of Self-Reported Spray Doses at Week 10
timeFrame: Week 10
measure: Total Daily Number of Self-Reported Spray Doses at Week 11
timeFrame: Week 11
measure: Total Daily Number of Self-Reported Spray Doses at Week 12
timeFrame: Week 12
measure: Total Daily Number of Self-Reported Spray Doses at Week 13
timeFrame: Week 13
measure: Total Daily Number of Self-Reported Spray Doses at Week 14
timeFrame: Week 14
measure: Total Daily Number of Self-Reported Spray Doses at Week 15
timeFrame: Week 15
measure: Total Daily Number of Self-Reported Spray Doses at Week 16
timeFrame: Week 16
measure: Total Daily Number of Self-Reported Spray Doses at Week 17
timeFrame: Week 17
measure: Total Daily Number of Self-Reported Spray Doses at Week 18
timeFrame: Week 18
measure: Total Daily Number of Self-Reported Spray Doses at Week 19
timeFrame: Week 19
measure: Total Daily Number of Self-Reported Spray Doses at Week 20
timeFrame: Week 20
measure: Total Daily Number of Self-Reported Spray Doses at Week 21
timeFrame: Week 21
measure: Total Daily Number of Self-Reported Spray Doses at Week 22
timeFrame: Week 22
measure: Total Daily Number of Self-Reported Spray Doses at Week 23
timeFrame: Week 23
measure: Total Daily Number of Self-Reported Spray Doses at Week 24
timeFrame: Week 24
measure: Total Daily Number of Self-Reported Spray Doses at Week 25
timeFrame: Week 25
measure: Total Daily Number of Self-Reported Spray Doses at Week 26
timeFrame: Week 26
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 1
timeFrame: Week 1
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 2
timeFrame: Week 2
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 3
timeFrame: Week 3
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 4
timeFrame: Week 4
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 5
timeFrame: Week 5
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 6
timeFrame: Week 6
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 7
timeFrame: Week 7
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 8
timeFrame: Week 8
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 9
timeFrame: Week 9
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 10
timeFrame: Week 10
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 11
timeFrame: Week 11
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 12
timeFrame: Week 12
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 13
timeFrame: Week 13
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 14
timeFrame: Week 14
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 15
timeFrame: Week 15
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 16
timeFrame: Week 16
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 17
timeFrame: Week 17
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 18
timeFrame: Week 18
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 19
timeFrame: Week 19
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 20
timeFrame: Week 20
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 21
timeFrame: Week 21
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 22
timeFrame: Week 22
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 23
timeFrame: Week 23
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 24
timeFrame: Week 24
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 25
timeFrame: Week 25
measure: Maximum Total Daily Number of Self-Reported Spray Doses at Week 26
timeFrame: Week 26
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 1
timeFrame: Week 1
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 2
timeFrame: Week 2
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 3
timeFrame: Week 3
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 4
timeFrame: Week 4
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 5
timeFrame: Week 5
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 6
timeFrame: Week 6
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 7
timeFrame: Week 7
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 8
timeFrame: Week 8
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 9
timeFrame: Week 9
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 10
timeFrame: Week 10
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 11
timeFrame: Week 11
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 12
timeFrame: Week 12
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 13
timeFrame: Week 13
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 14
timeFrame: Week 14
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 15
timeFrame: Week 15
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 16
timeFrame: Week 16
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 17
timeFrame: Week 17
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 18
timeFrame: Week 18
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 19
timeFrame: Week 19
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 20
timeFrame: Week 20
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 21
timeFrame: Week 21
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 22
timeFrame: Week 22
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 23
timeFrame: Week 23
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 24
timeFrame: Week 24
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 25
timeFrame: Week 25
measure: Maximum Hourly Number of Self-Reported Spray Doses at Week 26
timeFrame: Week 26
measure: Number of Cigarettes Smoked Since Last Visit at Week 1
timeFrame: Week 1
measure: Number of Cigarettes Smoked Since Last Visit at Week 2
timeFrame: Week 2
measure: Number of Cigarettes Smoked Per Day at Week 4
timeFrame: Week 4
measure: Number of Cigarettes Smoked Per Day at Week 6
timeFrame: Week 6
measure: Number of Cigarettes Smoked Per Day at Week 8
timeFrame: Week 8
measure: Number of Cigarettes Smoked Per Day at Week 12
timeFrame: Week 12
measure: Number of Cigarettes Smoked Per Day at Week 16
timeFrame: Week 16
measure: Number of Cigarettes Smoked Per Day at Week 20
timeFrame: Week 20
measure: Number of Cigarettes Smoked Per Day at Week 26
timeFrame: Week 26
measure: Percentage Distribution of the Participant Score for Overall Product Rating at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Participant Score for Overall Product Rating at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Participant Score for Overall Product Rating at Week 12
timeFrame: Week 12
measure: Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12
timeFrame: Week 12
measure: Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12
timeFrame: Week 12
measure: Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product
timeFrame: Week 1
measure: Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product
timeFrame: Week 6
measure: Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product
timeFrame: Week 12
measure: Percentage Distribution of the Participant Score for Product Convenience at Week 1
timeFrame: Week 1
measure: Percentage Distribution of the Participant Score for Product Convenience at Week 6
timeFrame: Week 6
measure: Percentage Distribution of the Participant Score for Product Convenience at Week 12
timeFrame: Week 12
measure: Systolic Blood Pressure at Week 1
timeFrame: Week 1
measure: Systolic Blood Pressure at Week 2
timeFrame: Week 2
measure: Systolic Blood Pressure at Week 4
timeFrame: Week 4
measure: Systolic Blood Pressure at Week 6
timeFrame: Week 6
measure: Systolic Blood Pressure at Week 8
timeFrame: Week 8
measure: Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Systolic Blood Pressure at Week 16
timeFrame: Week 16
measure: Systolic Blood Pressure at Week 20
timeFrame: Week 20
measure: Systolic Blood Pressure at Week 26
timeFrame: Week 26
measure: Change From Baseline in Systolic Blood Pressure at Week 1
timeFrame: Baseline to Week 1
measure: Change From Baseline in Systolic Blood Pressure at Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Systolic Blood Pressure at Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Systolic Blood Pressure at Week 6
timeFrame: Baseline to Week 6
measure: Change From Baseline in Systolic Blood Pressure at Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Systolic Blood Pressure at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Systolic Blood Pressure at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Systolic Blood Pressure at Week 20
timeFrame: Baseline to Week 20
measure: Change From Baseline in Systolic Blood Pressure at Week 26
timeFrame: Baseline to Week 26
measure: Diastolic Blood Pressure at Week 1
timeFrame: Week 1
measure: Diastolic Blood Pressure at Week 2
timeFrame: Week 2
measure: Diastolic Blood Pressure at Week 4
timeFrame: Week 4
measure: Diastolic Blood Pressure at Week 6
timeFrame: Week 6
measure: Diastolic Blood Pressure at Week 8
timeFrame: Week 8
measure: Diastolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Diastolic Blood Pressure at Week 16
timeFrame: Week 16
measure: Diastolic Blood Pressure at Week 20
timeFrame: Week 20
measure: Diastolic Blood Pressure at Week 26
timeFrame: Week 26
measure: Change From Baseline in Diastolic Blood Pressure at Week 1
timeFrame: Baseline to Week 1
measure: Change From Baseline in Diastolic Blood Pressure at Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Diastolic Blood Pressure at Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Diastolic Blood Pressure at Week 6
timeFrame: Baseline to Week 6
measure: Change From Baseline in Diastolic Blood Pressure at Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Diastolic Blood Pressure at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Diastolic Blood Pressure at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Diastolic Blood Pressure at Week 20
timeFrame: Baseline to Week 20
measure: Change From Baseline in Diastolic Blood Pressure at Week 26
timeFrame: Baseline to Week 26
measure: Pulse at Week 1
timeFrame: Week 1
measure: Pulse at Week 2
timeFrame: Week 2
measure: Pulse at Week 4
timeFrame: Week 4
measure: Pulse at Week 6
timeFrame: Week 6
measure: Pulse at Week 8
timeFrame: Week 8
measure: Pulse at Week 12
timeFrame: Week 12
measure: Pulse at Week 16
timeFrame: Week 16
measure: Pulse at Week 20
timeFrame: Week 20
measure: Pulse at Week 26
timeFrame: Week 26
measure: Change From Baseline in Pulse at Week 1
timeFrame: Baseline to Week 1
measure: Change From Baseline in Pulse at Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Pulse at Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Pulse at Week 6
timeFrame: Baseline to Week 6
measure: Change From Baseline in Pulse at Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Pulse at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Pulse at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Pulse at Week 20
timeFrame: Baseline to Week 20
measure: Change From Baseline in Pulse at Week 26
timeFrame: Baseline to Week 26
measure: Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study
timeFrame: Week 6 or when withdrawn from study
measure: Change From Baseline in Body Weight at Week 6
timeFrame: Baseline to Week 6
measure: Change From Baseline in Body Weight at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Body Weight at Week 26
timeFrame: Baseline to Week 26
measure: Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
timeFrame: Baseline to Week 6
measure: Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
timeFrame: Baseline to Week 12
measure: Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Burbank
country: United States
facility: Los Angeles Clinical Trials
state: California
city: Chicago
country: United States
facility: Radiant Research, Inc
state: Illinois
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Dallas
country: United States
facility: Radiant Research, Inc
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research, Inc
state: Utah
Study officials:
affiliation: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
name: Andrew Myers, MD
role: STUDY_DIRECTOR
References:
citation: Nides M, Danielsson T, Saunders F, Perfekt R, Kapikian R, Solla J, Leischow SJ, Myers A. Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A Randomized, Multicenter, Controlled Study in a Naturalistic Setting. Nicotine Tob Res. 2020 Mar 16;22(3):339-345. doi: 10.1093/ntr/nty246.