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Completed

NCT Number: NCT02355665

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

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.

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Key information

Conditions

Tobacco Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine Spray

Drug

Nicotine Spray

Placebo

Drug

Placebo to match nicotine spray

Primary outcomes

  1. 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

  1. Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12

    Time frame: Week 2 to Week 12

    Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

  2. Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26

    Time frame: Week 2 to Week 26

    Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

  3. Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4

    Time frame: Week 2 to Week 4

    Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

  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 carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

  5. Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16

    Time frame: Week 2 to Week 16

    Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

  6. Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20

    Time frame: Week 2 to Week 20

    Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

  7. Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1

    Time frame: 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).

  8. Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2

    Time frame: 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).

  9. Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4

    Time frame: 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).

  10. Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6

    Time frame: 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).

  11. Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1

    Time frame: 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).

  12. Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2

    Time frame: 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).

  13. Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4

    Time frame: 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).

  14. Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6

    Time frame: 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).

  15. Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1

    Time frame: 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).

  16. Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2

    Time frame: 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).

  17. Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4

    Time frame: 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).

  18. Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6

    Time frame: 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).

  19. Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1

    Time frame: 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).

  20. Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2

    Time frame: 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).

  21. Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4

    Time frame: 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).

  22. Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6

    Time frame: 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).

  23. Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1

    Time frame: 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).

  24. Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2

    Time frame: 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).

  25. Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4

    Time frame: 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).

  26. Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6

    Time frame: 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).

  27. Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1

    Time frame: 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).

  28. Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2

    Time frame: 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).

  29. Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4

    Time frame: 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).

  30. Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6

    Time frame: 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).

  31. Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1

    Time frame: 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).

  32. Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2

    Time frame: 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).

  33. Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4

    Time frame: 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).

  34. Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6

    Time frame: 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).

  35. Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1

    Time frame: 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).

  36. Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2

    Time frame: 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).

  37. Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4

    Time frame: 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).

  38. Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6

    Time frame: 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).

  39. Aggregated Withdrawal Score at Week 1

    Time frame: 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.

  40. Aggregated Withdrawal Score at Week 2

    Time frame: 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.

  41. Aggregated Withdrawal Score at Week 4

    Time frame: 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.

  42. Aggregated Withdrawal Score at Week 6

    Time frame: 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.

  43. Total Daily Number of Self-Reported Spray Doses at Week 1

    Time frame: Week 1

    Total Daily Number of Self-Reported Spray Doses

  44. Total Daily Number of Self-Reported Spray Doses at Week 2

    Time frame: Week 2

    Total Daily Number of Self-Reported Spray Doses

  45. Total Daily Number of Self-Reported Spray Doses at Week 3

    Time frame: Week 3

    Total Daily Number of Self-Reported Spray Doses

  46. Total Daily Number of Self-Reported Spray Doses at Week 4

    Time frame: Week 4

    Total Daily Number of Self-Reported Spray Doses

  47. Total Daily Number of Self-Reported Spray Doses at Week 5

    Time frame: Week 5

    Total Daily Number of Self-Reported Spray Doses

  48. Total Daily Number of Self-Reported Spray Doses at Week 6

    Time frame: Week 6

    Total Daily Number of Self-Reported Spray Doses

  49. Total Daily Number of Self-Reported Spray Doses at Week 7

    Time frame: Week 7

    Total Daily Number of Self-Reported Spray Doses

  50. Total Daily Number of Self-Reported Spray Doses at Week 8

    Time frame: Week 8

    Total Daily Number of Self-Reported Spray Doses

  51. Total Daily Number of Self-Reported Spray Doses at Week 9

    Time frame: Week 9

    Total Daily Number of Self-Reported Spray Doses

  52. Total Daily Number of Self-Reported Spray Doses at Week 10

    Time frame: Week 10

    Total Daily Number of Self-Reported Spray Doses

  53. Total Daily Number of Self-Reported Spray Doses at Week 11

    Time frame: Week 11

    Total Daily Number of Self-Reported Spray Doses

  54. Total Daily Number of Self-Reported Spray Doses at Week 12

    Time frame: Week 12

    Total Daily Number of Self-Reported Spray Doses

  55. Total Daily Number of Self-Reported Spray Doses at Week 13

    Time frame: Week 13

    Total Daily Number of Self-Reported Spray Doses

  56. Total Daily Number of Self-Reported Spray Doses at Week 14

    Time frame: Week 14

    Total Daily Number of Self-Reported Spray Doses

  57. Total Daily Number of Self-Reported Spray Doses at Week 15

    Time frame: Week 15

    Total Daily Number of Self-Reported Spray Doses

  58. Total Daily Number of Self-Reported Spray Doses at Week 16

    Time frame: Week 16

    Total Daily Number of Self-Reported Spray Doses

  59. Total Daily Number of Self-Reported Spray Doses at Week 17

    Time frame: Week 17

    Total Daily Number of Self-Reported Spray Doses

  60. Total Daily Number of Self-Reported Spray Doses at Week 18

    Time frame: Week 18

    Total Daily Number of Self-Reported Spray Doses

  61. Total Daily Number of Self-Reported Spray Doses at Week 19

    Time frame: Week 19

    Total Daily Number of Self-Reported Spray Doses

  62. Total Daily Number of Self-Reported Spray Doses at Week 20

    Time frame: Week 20

    Total Daily Number of Self-Reported Spray Doses

  63. Total Daily Number of Self-Reported Spray Doses at Week 21

    Time frame: Week 21

    Total Daily Number of Self-Reported Spray Doses

  64. Total Daily Number of Self-Reported Spray Doses at Week 22

    Time frame: Week 22

    Total Daily Number of Self-Reported Spray Doses

  65. Total Daily Number of Self-Reported Spray Doses at Week 23

    Time frame: Week 23

    Total Daily Number of Self-Reported Spray Doses

  66. Total Daily Number of Self-Reported Spray Doses at Week 24

    Time frame: Week 24

    Total Daily Number of Self-Reported Spray Doses

  67. Total Daily Number of Self-Reported Spray Doses at Week 25

    Time frame: Week 25

    Total Daily Number of Self-Reported Spray Doses

  68. Total Daily Number of Self-Reported Spray Doses at Week 26

    Time frame: Week 26

    Total Daily Number of Self-Reported Spray Doses

  69. Maximum Total Daily Number of Self-Reported Spray Doses at Week 1

    Time frame: Week 1

    Maximum Total Daily Number of Self-Reported Spray Doses

  70. Maximum Total Daily Number of Self-Reported Spray Doses at Week 2

    Time frame: Week 2

    Maximum Total Daily Number of Self-Reported Spray Doses

  71. Maximum Total Daily Number of Self-Reported Spray Doses at Week 3

    Time frame: Week 3

    Maximum Total Daily Number of Self-Reported Spray Doses

  72. Maximum Total Daily Number of Self-Reported Spray Doses at Week 4

    Time frame: Week 4

    Maximum Total Daily Number of Self-Reported Spray Doses

  73. Maximum Total Daily Number of Self-Reported Spray Doses at Week 5

    Time frame: Week 5

    Maximum Total Daily Number of Self-Reported Spray Doses

  74. Maximum Total Daily Number of Self-Reported Spray Doses at Week 6

    Time frame: Week 6

    Maximum Total Daily Number of Self-Reported Spray Doses

  75. Maximum Total Daily Number of Self-Reported Spray Doses at Week 7

    Time frame: Week 7

    Maximum Total Daily Number of Self-Reported Spray Doses

  76. Maximum Total Daily Number of Self-Reported Spray Doses at Week 8

    Time frame: Week 8

    Maximum Total Daily Number of Self-Reported Spray Doses

  77. Maximum Total Daily Number of Self-Reported Spray Doses at Week 9

    Time frame: Week 9

    Maximum Total Daily Number of Self-Reported Spray Doses

  78. Maximum Total Daily Number of Self-Reported Spray Doses at Week 10

    Time frame: Week 10

    Maximum Total Daily Number of Self-Reported Spray Doses

  79. Maximum Total Daily Number of Self-Reported Spray Doses at Week 11

    Time frame: Week 11

    Maximum Total Daily Number of Self-Reported Spray Doses

  80. Maximum Total Daily Number of Self-Reported Spray Doses at Week 12

    Time frame: Week 12

    Maximum Total Daily Number of Self-Reported Spray Doses

  81. Maximum Total Daily Number of Self-Reported Spray Doses at Week 13

    Time frame: Week 13

    Maximum Total Daily Number of Self-Reported Spray Doses

  82. Maximum Total Daily Number of Self-Reported Spray Doses at Week 14

    Time frame: Week 14

    Maximum Total Daily Number of Self-Reported Spray Doses

  83. Maximum Total Daily Number of Self-Reported Spray Doses at Week 15

    Time frame: Week 15

    Maximum Total Daily Number of Self-Reported Spray Doses

  84. Maximum Total Daily Number of Self-Reported Spray Doses at Week 16

    Time frame: Week 16

    Maximum Total Daily Number of Self-Reported Spray Doses

  85. Maximum Total Daily Number of Self-Reported Spray Doses at Week 17

    Time frame: Week 17

    Maximum Total Daily Number of Self-Reported Spray Doses

  86. Maximum Total Daily Number of Self-Reported Spray Doses at Week 18

    Time frame: Week 18

    Maximum Total Daily Number of Self-Reported Spray Doses

  87. Maximum Total Daily Number of Self-Reported Spray Doses at Week 19

    Time frame: Week 19

    Maximum Total Daily Number of Self-Reported Spray Doses

  88. Maximum Total Daily Number of Self-Reported Spray Doses at Week 20

    Time frame: Week 20

    Maximum Total Daily Number of Self-Reported Spray Doses

  89. Maximum Total Daily Number of Self-Reported Spray Doses at Week 21

    Time frame: Week 21

    Maximum Total Daily Number of Self-Reported Spray Doses

  90. Maximum Total Daily Number of Self-Reported Spray Doses at Week 22

    Time frame: Week 22

    Maximum Total Daily Number of Self-Reported Spray Doses

  91. Maximum Total Daily Number of Self-Reported Spray Doses at Week 23

    Time frame: Week 23

    Maximum Total Daily Number of Self-Reported Spray Doses

  92. Maximum Total Daily Number of Self-Reported Spray Doses at Week 24

    Time frame: Week 24

    Maximum Total Daily Number of Self-Reported Spray Doses

  93. Maximum Total Daily Number of Self-Reported Spray Doses at Week 25

    Time frame: Week 25

    Maximum Total Daily Number of Self-Reported Spray Doses

  94. Maximum Total Daily Number of Self-Reported Spray Doses at Week 26

    Time frame: Week 26

    Maximum Total Daily Number of Self-Reported Spray Doses

  95. Maximum Hourly Number of Self-Reported Spray Doses at Week 1

    Time frame: Week 1

    Maximum Hourly Number of Self-Reported Spray Doses

  96. Maximum Hourly Number of Self-Reported Spray Doses at Week 2

    Time frame: Week 2

    Maximum Hourly Number of Self-Reported Spray Doses

  97. Maximum Hourly Number of Self-Reported Spray Doses at Week 3

    Time frame: Week 3

    Maximum Hourly Number of Self-Reported Spray Doses

  98. Maximum Hourly Number of Self-Reported Spray Doses at Week 4

    Time frame: Week 4

    Maximum Hourly Number of Self-Reported Spray Doses

  99. Maximum Hourly Number of Self-Reported Spray Doses at Week 5

    Time frame: Week 5

    Maximum Hourly Number of Self-Reported Spray Doses

  100. Maximum Hourly Number of Self-Reported Spray Doses at Week 6

    Time frame: Week 6

    Maximum Hourly Number of Self-Reported Spray Doses

  101. Maximum Hourly Number of Self-Reported Spray Doses at Week 7

    Time frame: Week 7

    Maximum Hourly Number of Self-Reported Spray Doses

  102. Maximum Hourly Number of Self-Reported Spray Doses at Week 8

    Time frame: Week 8

    Maximum Hourly Number of Self-Reported Spray Doses

  103. Maximum Hourly Number of Self-Reported Spray Doses at Week 9

    Time frame: Week 9

    Maximum Hourly Number of Self-Reported Spray Doses

  104. Maximum Hourly Number of Self-Reported Spray Doses at Week 10

    Time frame: Week 10

    Maximum Hourly Number of Self-Reported Spray Doses

  105. Maximum Hourly Number of Self-Reported Spray Doses at Week 11

    Time frame: Week 11

    Maximum Hourly Number of Self-Reported Spray Doses

  106. Maximum Hourly Number of Self-Reported Spray Doses at Week 12

    Time frame: Week 12

    Maximum Hourly Number of Self-Reported Spray Doses

  107. Maximum Hourly Number of Self-Reported Spray Doses at Week 13

    Time frame: Week 13

    Maximum Hourly Number of Self-Reported Spray Doses

  108. Maximum Hourly Number of Self-Reported Spray Doses at Week 14

    Time frame: Week 14

    Maximum Hourly Number of Self-Reported Spray Doses

  109. Maximum Hourly Number of Self-Reported Spray Doses at Week 15

    Time frame: Week 15

    Maximum Hourly Number of Self-Reported Spray Doses

  110. Maximum Hourly Number of Self-Reported Spray Doses at Week 16

    Time frame: Week 16

    Maximum Hourly Number of Self-Reported Spray Doses

  111. Maximum Hourly Number of Self-Reported Spray Doses at Week 17

    Time frame: Week 17

    Maximum Hourly Number of Self-Reported Spray Doses

  112. Maximum Hourly Number of Self-Reported Spray Doses at Week 18

    Time frame: Week 18

    Maximum Hourly Number of Self-Reported Spray Doses

  113. Maximum Hourly Number of Self-Reported Spray Doses at Week 19

    Time frame: Week 19

    Maximum Hourly Number of Self-Reported Spray Doses

  114. Maximum Hourly Number of Self-Reported Spray Doses at Week 20

    Time frame: Week 20

    Maximum Hourly Number of Self-Reported Spray Doses

  115. Maximum Hourly Number of Self-Reported Spray Doses at Week 21

    Time frame: Week 21

    Maximum Hourly Number of Self-Reported Spray Doses

  116. Maximum Hourly Number of Self-Reported Spray Doses at Week 22

    Time frame: Week 22

    Maximum Hourly Number of Self-Reported Spray Doses

  117. Maximum Hourly Number of Self-Reported Spray Doses at Week 23

    Time frame: Week 23

    Maximum Hourly Number of Self-Reported Spray Doses

  118. Maximum Hourly Number of Self-Reported Spray Doses at Week 24

    Time frame: Week 24

    Maximum Hourly Number of Self-Reported Spray Doses

  119. Maximum Hourly Number of Self-Reported Spray Doses at Week 25

    Time frame: Week 25

    Maximum Hourly Number of Self-Reported Spray Doses

  120. Maximum Hourly Number of Self-Reported Spray Doses at Week 26

    Time frame: Week 26

    Maximum Hourly Number of Self-Reported Spray Doses

  121. Number of Cigarettes Smoked Since Last Visit at Week 1

    Time frame: Week 1

    Number of Cigarettes Smoked Since Last Visit

  122. Number of Cigarettes Smoked Since Last Visit at Week 2

    Time frame: Week 2

    Number of Cigarettes Smoked Since Last Visit

  123. Number of Cigarettes Smoked Per Day at Week 4

    Time frame: Week 4

    Number of Cigarettes Smoked Per Day

  124. Number of Cigarettes Smoked Per Day at Week 6

    Time frame: Week 6

    Number of Cigarettes Smoked Per Day

  125. Number of Cigarettes Smoked Per Day at Week 8

    Time frame: Week 8

    Number of Cigarettes Smoked Per Day

  126. Number of Cigarettes Smoked Per Day at Week 12

    Time frame: Week 12

    Number of Cigarettes Smoked Per Day

  127. Number of Cigarettes Smoked Per Day at Week 16

    Time frame: Week 16

    Number of Cigarettes Smoked Per Day

  128. Number of Cigarettes Smoked Per Day at Week 20

    Time frame: Week 20

    Number of Cigarettes Smoked Per Day

  129. Number of Cigarettes Smoked Per Day at Week 26

    Time frame: Week 26

    Number of Cigarettes Smoked Per Day

  130. Percentage Distribution of the Participant Score for Overall Product Rating at Week 1

    Time frame: 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).

  131. Percentage Distribution of the Participant Score for Overall Product Rating at Week 6

    Time frame: 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).

  132. Percentage Distribution of the Participant Score for Overall Product Rating at Week 12

    Time frame: 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).

  133. Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1

    Time frame: 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).

  134. Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6

    Time frame: 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).

  135. Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12

    Time frame: 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).

  136. Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1

    Time frame: 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).

  137. Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6

    Time frame: 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).

  138. Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12

    Time frame: 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).

  139. Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product

    Time frame: Week 1

    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).

  140. Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product

    Time frame: Week 6

    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).

  141. Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product

    Time frame: Week 12

    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).

  142. Percentage Distribution of the Participant Score for Product Convenience at Week 1

    Time frame: 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).

  143. Percentage Distribution of the Participant Score for Product Convenience at Week 6

    Time frame: 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).

  144. Percentage Distribution of the Participant Score for Product Convenience at Week 12

    Time frame: 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).

  145. Systolic Blood Pressure at Week 1

    Time frame: Week 1

    Systolic blood pressure (mm Hg)

  146. Systolic Blood Pressure at Week 2

    Time frame: Week 2

    Systolic blood pressure (mm Hg)

  147. Systolic Blood Pressure at Week 4

    Time frame: Week 4

    Systolic blood pressure (mm Hg)

  148. Systolic Blood Pressure at Week 6

    Time frame: Week 6

    Systolic blood pressure (mm Hg)

  149. Systolic Blood Pressure at Week 8

    Time frame: Week 8

    Systolic blood pressure (mm Hg)

  150. Systolic Blood Pressure at Week 12

    Time frame: Week 12

    Systolic blood pressure (mm Hg)

  151. Systolic Blood Pressure at Week 16

    Time frame: Week 16

    Systolic blood pressure (mm Hg)

  152. Systolic Blood Pressure at Week 20

    Time frame: Week 20

    Systolic blood pressure (mm Hg)

  153. Systolic Blood Pressure at Week 26

    Time frame: Week 26

    Systolic blood pressure (mm Hg)

  154. Change From Baseline in Systolic Blood Pressure at Week 1

    Time frame: Baseline to Week 1

    Change from baseline in systolic blood pressure (mm Hg)

  155. Change From Baseline in Systolic Blood Pressure at Week 2

    Time frame: Baseline to Week 2

    Change from baseline in systolic blood pressure (mm Hg)

  156. Change From Baseline in Systolic Blood Pressure at Week 4

    Time frame: Baseline to Week 4

    Change from baseline in systolic blood pressure (mm Hg)

  157. Change From Baseline in Systolic Blood Pressure at Week 6

    Time frame: Baseline to Week 6

    Change from baseline in systolic blood pressure (mm Hg)

  158. Change From Baseline in Systolic Blood Pressure at Week 8

    Time frame: Baseline to Week 8

    Change from baseline in systolic blood pressure (mm Hg)

  159. Change From Baseline in Systolic Blood Pressure at Week 12

    Time frame: Baseline to Week 12

    Change from baseline in systolic blood pressure (mm Hg)

  160. Change From Baseline in Systolic Blood Pressure at Week 16

    Time frame: Baseline to Week 16

    Change from baseline in systolic blood pressure (mm Hg)

  161. Change From Baseline in Systolic Blood Pressure at Week 20

    Time frame: Baseline to Week 20

    Change from baseline in systolic blood pressure (mm Hg)

  162. Change From Baseline in Systolic Blood Pressure at Week 26

    Time frame: Baseline to Week 26

    Change from baseline in systolic blood pressure (mm Hg)

  163. Diastolic Blood Pressure at Week 1

    Time frame: Week 1

    Diastolic blood pressure (mm Hg)

  164. Diastolic Blood Pressure at Week 2

    Time frame: Week 2

    Diastolic blood pressure (mm Hg)

  165. Diastolic Blood Pressure at Week 4

    Time frame: Week 4

    Diastolic blood pressure (mm Hg)

  166. Diastolic Blood Pressure at Week 6

    Time frame: Week 6

    Diastolic blood pressure (mm Hg)

  167. Diastolic Blood Pressure at Week 8

    Time frame: Week 8

    Diastolic blood pressure (mm Hg)

  168. Diastolic Blood Pressure at Week 12

    Time frame: Week 12

    Diastolic blood pressure (mm Hg)

  169. Diastolic Blood Pressure at Week 16

    Time frame: Week 16

    Diastolic blood pressure (mm Hg)

  170. Diastolic Blood Pressure at Week 20

    Time frame: Week 20

    Diastolic blood pressure (mm Hg)

  171. Diastolic Blood Pressure at Week 26

    Time frame: Week 26

    Diastolic blood pressure (mm Hg)

  172. Change From Baseline in Diastolic Blood Pressure at Week 1

    Time frame: Baseline to Week 1

    Change from baseline in diastolic blood pressure (mm Hg)

  173. Change From Baseline in Diastolic Blood Pressure at Week 2

    Time frame: Baseline to Week 2

    Change from baseline in diastolic blood pressure (mm Hg)

  174. Change From Baseline in Diastolic Blood Pressure at Week 4

    Time frame: Baseline to Week 4

    Change from baseline in diastolic blood pressure (mm Hg)

  175. Change From Baseline in Diastolic Blood Pressure at Week 6

    Time frame: Baseline to Week 6

    Change from baseline in diastolic blood pressure (mm Hg)

  176. Change From Baseline in Diastolic Blood Pressure at Week 8

    Time frame: Baseline to Week 8

    Change from baseline in diastolic blood pressure (mm Hg)

  177. Change From Baseline in Diastolic Blood Pressure at Week 12

    Time frame: Baseline to Week 12

    Change from baseline in diastolic blood pressure (mm Hg)

  178. Change From Baseline in Diastolic Blood Pressure at Week 16

    Time frame: Baseline to Week 16

    Change from baseline in diastolic blood pressure (mm Hg)

  179. Change From Baseline in Diastolic Blood Pressure at Week 20

    Time frame: Baseline to Week 20

    Change from baseline in diastolic blood pressure (mm Hg)

  180. Change From Baseline in Diastolic Blood Pressure at Week 26

    Time frame: Baseline to Week 26

    Change from baseline in diastolic blood pressure (mm Hg)

  181. Pulse at Week 1

    Time frame: Week 1

    Pulse (beats per minute)

  182. Pulse at Week 2

    Time frame: Week 2

    Pulse (beats per minute)

  183. Pulse at Week 4

    Time frame: Week 4

    Pulse (beats per minute)

  184. Pulse at Week 6

    Time frame: Week 6

    Pulse (beats per minute)

  185. Pulse at Week 8

    Time frame: Week 8

    Pulse (beats per minute)

  186. Pulse at Week 12

    Time frame: Week 12

    Pulse (beats per minute)

  187. Pulse at Week 16

    Time frame: Week 16

    Pulse (beats per minute)

  188. Pulse at Week 20

    Time frame: Week 20

    Pulse (beats per minute)

  189. Pulse at Week 26

    Time frame: Week 26

    Pulse (beats per minute)

  190. Change From Baseline in Pulse at Week 1

    Time frame: Baseline to Week 1

    Change from baseline in pulse (beats per minute)

  191. Change From Baseline in Pulse at Week 2

    Time frame: Baseline to Week 2

    Change from baseline in pulse (beats per minute)

  192. Change From Baseline in Pulse at Week 4

    Time frame: Baseline to Week 4

    Change from baseline in pulse (beats per minute)

  193. Change From Baseline in Pulse at Week 6

    Time frame: Baseline to Week 6

    Change from baseline in pulse (beats per minute)

  194. Change From Baseline in Pulse at Week 8

    Time frame: Baseline to Week 8

    Change from baseline in pulse (beats per minute)

  195. Change From Baseline in Pulse at Week 12

    Time frame: Baseline to Week 12

    Change from baseline in pulse (beats per minute)

  196. Change From Baseline in Pulse at Week 16

    Time frame: Baseline to Week 16

    Change from baseline in pulse (beats per minute)

  197. Change From Baseline in Pulse at Week 20

    Time frame: Baseline to Week 20

    Change from baseline in pulse (beats per minute)

  198. Change From Baseline in Pulse at Week 26

    Time frame: Baseline to Week 26

    Change from baseline in pulse (beats per minute)

  199. Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study

    Time frame: 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.

  200. Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study

    Time frame: 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.

  201. Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study

    Time frame: 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.

  202. Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study

    Time frame: 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.

  203. Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study

    Time frame: 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.

  204. Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study

    Time frame: 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.

  205. Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study

    Time frame: 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.

  206. Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study

    Time frame: 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.

  207. Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study

    Time frame: 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.

  208. Change From Baseline in Body Weight at Week 6

    Time frame: Baseline to Week 6

    Change from baseline in body weight

  209. Change From Baseline in Body Weight at Week 12

    Time frame: Baseline to Week 12

    Change from baseline in body weight

  210. Change From Baseline in Body Weight at Week 26

    Time frame: Baseline to Week 26

    Change from baseline in body weight

  211. Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit

    Time frame: Baseline to Week 6

    Change from baseline in body weight

  212. Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit

    Time frame: Baseline to Week 12

    Change from baseline in body weight

  213. Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit

    Time frame: Baseline to Week 26

    Change from baseline in body weight

Sponsors and collaborators

Lead sponsor

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Industry

Collaborators

  • GlaxoSmithKline
  • McNeil AB

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 4, 2015
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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