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

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.6 sites in 1 country1,198 target enrollmentJanuary 31, 2015

ConditionsTobacco Dependence

InterventionsNicotine Spray Placebo

DrugsNicotine Spray Placebo

Overview

Phase: Phase 3
Intervention: Nicotine Spray
Conditions: Tobacco Dependence
Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Enrollment: 1198
Locations: 6
Primary Endpoint: Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 31, 2015

End Date

February 10, 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Responsible Party

Sponsor

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.

Arms & Interventions

Nicotine

Nicotine Spray

Intervention: Nicotine Spray

Placebo

Placebo to match Nicotine spray

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

Pulse at Week 4(Week 4)
Pulse at Week 16(Week 16)
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12(Week 2 to Week 12)
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26(Week 2 to Week 26)
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6(Week 6)
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4(Week 2 to Week 4)
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16(Week 2 to Week 16)
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2(Week 2)
Total Daily Number of Self-Reported Spray Doses at Week 13(Week 13)
Total Daily Number of Self-Reported Spray Doses at Week 15(Week 15)
Total Daily Number of Self-Reported Spray Doses at Week 20(Week 20)
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1(Week 1)
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4(Week 4)
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6(Week 6)
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1(Week 1)
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2(Week 2)
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20(Week 2 to Week 20)
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2(Week 2)
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1(Week 1)
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1(Week 1)
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4(Week 4)
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4(Week 4)
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6(Week 6)
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2(Week 2)
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4(Week 4)
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8(Week 2 to Week 8)
Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2(Week 2)
Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4(Week 4)
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6(Week 6)
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1(Week 1)
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1(Week 1)
Total Daily Number of Self-Reported Spray Doses at Week 1(Week 1)
Total Daily Number of Self-Reported Spray Doses at Week 5(Week 5)
Total Daily Number of Self-Reported Spray Doses at Week 6(Week 6)
Total Daily Number of Self-Reported Spray Doses at Week 9(Week 9)
Total Daily Number of Self-Reported Spray Doses at Week 12(Week 12)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 6(Week 6)
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2(Week 2)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 7(Week 7)
Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4(Week 4)
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1(Week 1)
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4(Week 4)
Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6(Week 6)
Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6(Week 6)
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1(Week 1)
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4(Week 4)
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6(Week 6)
Aggregated Withdrawal Score at Week 4(Week 4)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 10(Week 10)
Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2(Week 2)
Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2(Week 2)
Aggregated Withdrawal Score at Week 1(Week 1)
Total Daily Number of Self-Reported Spray Doses at Week 7(Week 7)
Total Daily Number of Self-Reported Spray Doses at Week 17(Week 17)
Total Daily Number of Self-Reported Spray Doses at Week 18(Week 18)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 3(Week 3)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 5(Week 5)
Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6(Week 6)
Aggregated Withdrawal Score at Week 2(Week 2)
Total Daily Number of Self-Reported Spray Doses at Week 3(Week 3)
Total Daily Number of Self-Reported Spray Doses at Week 4(Week 4)
Total Daily Number of Self-Reported Spray Doses at Week 8(Week 8)
Total Daily Number of Self-Reported Spray Doses at Week 10(Week 10)
Total Daily Number of Self-Reported Spray Doses at Week 16(Week 16)
Total Daily Number of Self-Reported Spray Doses at Week 19(Week 19)
Total Daily Number of Self-Reported Spray Doses at Week 21(Week 21)
Total Daily Number of Self-Reported Spray Doses at Week 22(Week 22)
Total Daily Number of Self-Reported Spray Doses at Week 24(Week 24)
Total Daily Number of Self-Reported Spray Doses at Week 25(Week 25)
Total Daily Number of Self-Reported Spray Doses at Week 26(Week 26)
Aggregated Withdrawal Score at Week 6(Week 6)
Total Daily Number of Self-Reported Spray Doses at Week 2(Week 2)
Total Daily Number of Self-Reported Spray Doses at Week 11(Week 11)
Total Daily Number of Self-Reported Spray Doses at Week 14(Week 14)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 11(Week 11)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 16(Week 16)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 17(Week 17)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 19(Week 19)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 20(Week 20)
Maximum Hourly Number of Self-Reported Spray Doses at Week 1(Week 1)
Maximum Hourly Number of Self-Reported Spray Doses at Week 5(Week 5)
Maximum Hourly Number of Self-Reported Spray Doses at Week 11(Week 11)
Maximum Hourly Number of Self-Reported Spray Doses at Week 15(Week 15)
Maximum Hourly Number of Self-Reported Spray Doses at Week 16(Week 16)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 15(Week 15)
Total Daily Number of Self-Reported Spray Doses at Week 23(Week 23)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 1(Week 1)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 2(Week 2)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 9(Week 9)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 12(Week 12)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 14(Week 14)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 23(Week 23)
Maximum Hourly Number of Self-Reported Spray Doses at Week 3(Week 3)
Maximum Hourly Number of Self-Reported Spray Doses at Week 6(Week 6)
Maximum Hourly Number of Self-Reported Spray Doses at Week 7(Week 7)
Maximum Hourly Number of Self-Reported Spray Doses at Week 12(Week 12)
Maximum Hourly Number of Self-Reported Spray Doses at Week 13(Week 13)
Maximum Hourly Number of Self-Reported Spray Doses at Week 21(Week 21)
Number of Cigarettes Smoked Since Last Visit at Week 2(Week 2)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 8(Week 8)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 13(Week 13)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 18(Week 18)
Maximum Hourly Number of Self-Reported Spray Doses at Week 14(Week 14)
Maximum Hourly Number of Self-Reported Spray Doses at Week 23(Week 23)
Maximum Hourly Number of Self-Reported Spray Doses at Week 24(Week 24)
Number of Cigarettes Smoked Per Day at Week 16(Week 16)
Number of Cigarettes Smoked Per Day at Week 26(Week 26)
Percentage Distribution of the Participant Score for Overall Product Rating at Week 1(Week 1)
Change From Baseline in Systolic Blood Pressure at Week 4(Baseline to Week 4)
Change From Baseline in Systolic Blood Pressure at Week 12(Baseline to Week 12)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 4(Week 4)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 21(Week 21)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 24(Week 24)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 26(Week 26)
Maximum Hourly Number of Self-Reported Spray Doses at Week 4(Week 4)
Maximum Hourly Number of Self-Reported Spray Doses at Week 8(Week 8)
Maximum Hourly Number of Self-Reported Spray Doses at Week 9(Week 9)
Maximum Hourly Number of Self-Reported Spray Doses at Week 10(Week 10)
Maximum Hourly Number of Self-Reported Spray Doses at Week 17(Week 17)
Maximum Hourly Number of Self-Reported Spray Doses at Week 19(Week 19)
Number of Cigarettes Smoked Since Last Visit at Week 1(Week 1)
Number of Cigarettes Smoked Per Day at Week 4(Week 4)
Change From Baseline in Systolic Blood Pressure at Week 26(Baseline to Week 26)
Maximum Hourly Number of Self-Reported Spray Doses at Week 18(Week 18)
Diastolic Blood Pressure at Week 6(Week 6)
Maximum Hourly Number of Self-Reported Spray Doses at Week 20(Week 20)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 22(Week 22)
Maximum Total Daily Number of Self-Reported Spray Doses at Week 25(Week 25)
Maximum Hourly Number of Self-Reported Spray Doses at Week 2(Week 2)
Maximum Hourly Number of Self-Reported Spray Doses at Week 26(Week 26)
Number of Cigarettes Smoked Per Day at Week 6(Week 6)
Number of Cigarettes Smoked Per Day at Week 8(Week 8)
Number of Cigarettes Smoked Per Day at Week 12(Week 12)
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6(Week 6)
Systolic Blood Pressure at Week 6(Week 6)
Systolic Blood Pressure at Week 8(Week 8)
Maximum Hourly Number of Self-Reported Spray Doses at Week 22(Week 22)
Maximum Hourly Number of Self-Reported Spray Doses at Week 25(Week 25)
Percentage Distribution of the Participant Score for Overall Product Rating at Week 12(Week 12)
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12(Week 12)
Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product(Week 1)
Systolic Blood Pressure at Week 26(Week 26)
Number of Cigarettes Smoked Per Day at Week 20(Week 20)
Percentage Distribution of the Participant Score for Overall Product Rating at Week 6(Week 6)
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1(Week 1)
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12(Week 12)
Systolic Blood Pressure at Week 1(Week 1)
Systolic Blood Pressure at Week 20(Week 20)
Change From Baseline in Diastolic Blood Pressure at Week 26(Baseline to Week 26)
Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6(Week 6)
Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1(Week 1)
Percentage Distribution of the Participant Score for Product Convenience at Week 6(Week 6)
Change From Baseline in Systolic Blood Pressure at Week 1(Baseline to Week 1)
Change From Baseline in Systolic Blood Pressure at Week 6(Baseline to Week 6)
Change From Baseline in Pulse at Week 2(Baseline to Week 2)
Pulse at Week 2(Week 2)
Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product(Week 6)
Systolic Blood Pressure at Week 2(Week 2)
Change From Baseline in Systolic Blood Pressure at Week 8(Baseline to Week 8)
Change From Baseline in Systolic Blood Pressure at Week 20(Baseline to Week 20)
Diastolic Blood Pressure at Week 1(Week 1)
Diastolic Blood Pressure at Week 2(Week 2)
Pulse at Week 20(Week 20)
Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product(Week 12)
Percentage Distribution of the Participant Score for Product Convenience at Week 1(Week 1)
Percentage Distribution of the Participant Score for Product Convenience at Week 12(Week 12)
Systolic Blood Pressure at Week 4(Week 4)
Systolic Blood Pressure at Week 12(Week 12)
Systolic Blood Pressure at Week 16(Week 16)
Diastolic Blood Pressure at Week 16(Week 16)
Change From Baseline in Diastolic Blood Pressure at Week 6(Baseline to Week 6)
Change From Baseline in Diastolic Blood Pressure at Week 12(Baseline to Week 12)
Change From Baseline in Pulse at Week 1(Baseline to Week 1)
Change From Baseline in Pulse at Week 8(Baseline to Week 8)
Change From Baseline in Systolic Blood Pressure at Week 2(Baseline to Week 2)
Change From Baseline in Systolic Blood Pressure at Week 16(Baseline to Week 16)
Diastolic Blood Pressure at Week 12(Week 12)
Diastolic Blood Pressure at Week 20(Week 20)
Change From Baseline in Diastolic Blood Pressure at Week 4(Baseline to Week 4)
Pulse at Week 8(Week 8)
Pulse at Week 12(Week 12)
Change From Baseline in Pulse at Week 12(Baseline to Week 12)
Change From Baseline in Pulse at Week 26(Baseline to Week 26)
Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
Diastolic Blood Pressure at Week 4(Week 4)
Diastolic Blood Pressure at Week 8(Week 8)
Diastolic Blood Pressure at Week 26(Week 26)
Change From Baseline in Diastolic Blood Pressure at Week 1(Baseline to Week 1)
Change From Baseline in Diastolic Blood Pressure at Week 2(Baseline to Week 2)
Change From Baseline in Diastolic Blood Pressure at Week 8(Baseline to Week 8)
Change From Baseline in Diastolic Blood Pressure at Week 16(Baseline to Week 16)
Change From Baseline in Diastolic Blood Pressure at Week 20(Baseline to Week 20)
Pulse at Week 1(Week 1)
Pulse at Week 6(Week 6)
Pulse at Week 26(Week 26)
Change From Baseline in Pulse at Week 4(Baseline to Week 4)
Change From Baseline in Pulse at Week 6(Baseline to Week 6)
Change From Baseline in Pulse at Week 16(Baseline to Week 16)
Change From Baseline in Pulse at Week 20(Baseline to Week 20)
Change From Baseline in Body Weight at Week 12(Baseline to Week 12)
Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit(Baseline to Week 6)
Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit(Baseline to Week 12)
Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit(Baseline to Week 26)
Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
Change From Baseline in Body Weight at Week 6(Baseline to Week 6)
Change From Baseline in Body Weight at Week 26(Baseline to Week 26)
Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)