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Provoked Craving Assessment

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ClinicalTrials.gov Identifier: NCT01506908
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : January 30, 2014
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Smoking Dependence
Smoking
Interventions Drug: oral nicotine
Drug: Placebo
Enrollment 323
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details Of 423 screened participants, 323 were randomized while 94 did not meet the study criterion and remaining 6 discontinued due to other reasons. All randomized participants had a history of smoking more than 20 cigarettes per day.
Arm/Group Title Nicotine Lozenge 4 Milligrams (mg) Matched Placebo
Hide Arm/Group Description Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route. Participants received a single dose of matched placebo mint lozenge, through oral route.
Period Title: Overall Study
Started 162 161
Completed 161 161
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Nicotine Lozenge 4 mg Matched Placebo Total
Hide Arm/Group Description Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route. Participants received a single dose of matched placebo mint lozenge, through oral route. Total of all reporting groups
Overall Number of Baseline Participants 162 161 323
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants 161 participants 323 participants
43.69  (12.13) 44.45  (11.64) 44.07  (11.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 161 participants 323 participants
Female
75
  46.3%
74
  46.0%
149
  46.1%
Male
87
  53.7%
87
  54.0%
174
  53.9%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)/ meter (m)^2
Number Analyzed 162 participants 161 participants 323 participants
27.79  (3.73) 27.56  (4.05) 27.67  (3.89)
1.Primary Outcome
Title Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes
Hide Description Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
Time Frame Post-cue baseline,5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.
Arm/Group Title Nicotine Lozenge 4 mg Matched Placebo
Hide Arm/Group Description:
Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
Participants received a single dose of matched placebo mint lozenge, through oral route.
Overall Number of Participants Analyzed 162 161
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-41.8
(-45.8 to -37.7)
-25.9
(-30.0 to -21.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Lozenge 4 mg, Matched Placebo
Comments Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutes
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares means difference
Estimated Value -15.9
Confidence Interval (2-Sided) 95%
-21.6 to -10.2
Estimation Comments Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.
2.Secondary Outcome
Title Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute
Hide Description Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
Time Frame Post-cue baseline, 1 minute post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.
Arm/Group Title Nicotine Lozenge 4 mg Matched Placebo
Hide Arm/Group Description:
Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
Participants received a single dose of matched placebo mint lozenge, through oral route.
Overall Number of Participants Analyzed 162 161
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-17.2
(-20.1 to -14.2)
-12.9
(-15.9 to -10.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Lozenge 4 mg, Matched Placebo
Comments Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 1 minute.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0511
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares means difference
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-8.4 to 0.0
Estimation Comments Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.
3.Secondary Outcome
Title Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes
Hide Description Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
Time Frame Post-cue Baseline, 3 minutes post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.
Arm/Group Title Nicotine Lozenge 4 mg Matched Placebo
Hide Arm/Group Description:
Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
Participants received a single dose of matched placebo mint lozenge, through oral route.
Overall Number of Participants Analyzed 162 161
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-31.1
(-34.8 to -27.5)
-19.6
(-23.2 to -15.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Lozenge 4 mg, Matched Placebo
Comments Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 3 minutes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares means difference
Estimated Value -11.6
Confidence Interval (2-Sided) 95%
-16.7 to -6.4
Estimation Comments Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.
4.Secondary Outcome
Title Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes
Hide Description Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
Time Frame Post-Cue Baseline, 7 minutes post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.
Arm/Group Title Nicotine Lozenge 4 mg Matched Placebo
Hide Arm/Group Description:
Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
Participants received a single dose of matched placebo mint lozenge, through oral route.
Overall Number of Participants Analyzed 162 161
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-48.2
(-52.5 to -43.9)
-30.5
(-34.8 to -26.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Lozenge 4 mg, Matched Placebo
Comments Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 7 minutes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares means difference
Estimated Value -17.8
Confidence Interval (2-Sided) 95%
-23.8 to -11.7
Estimation Comments Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.
5.Secondary Outcome
Title Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes
Hide Description Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
Time Frame Post-Cue Baseline, 10 minutes post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique
Arm/Group Title Nicotine Lozenge 4 mg Matched Placebo
Hide Arm/Group Description:
Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
Participants received a single dose of matched placebo mint lozenge, through oral route.
Overall Number of Participants Analyzed 162 161
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-50.8
(-55.3 to -46.2)
-32.9
(-37.5 to -28.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Lozenge 4 mg, Matched Placebo
Comments Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 10 minutes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -17.9
Confidence Interval (2-Sided) 95%
-24.4 to -11.4
Estimation Comments Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)
Hide Description AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.
Time Frame Baseline to Day 5 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomized participants who received the study treatments were considered evaluable for safety.
Arm/Group Title Matched Placebo Nicotine Lozenge 4 mg
Hide Arm/Group Description:
Participants received a single dose of matched placebo mint lozenge, through oral route.
Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
Overall Number of Participants Analyzed 161 162
Measure Type: Number
Unit of Measure: Participants
AEs 12 54
Treatment Related AEs 11 54
SAEs 0 0
Time Frame All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nicotine Lozenge 4 mg Placebo Lozenge
Hide Arm/Group Description Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route. Participants received a single dose of matched placebo mint lozenge, through oral route.
All-Cause Mortality
Nicotine Lozenge 4 mg Placebo Lozenge
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Nicotine Lozenge 4 mg Placebo Lozenge
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/162 (0.00%)      0/161 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Nicotine Lozenge 4 mg Placebo Lozenge
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/162 (33.33%)      12/161 (7.45%)    
Ear and labyrinth disorders     
Ear Pain  1  0/162 (0.00%)  0 1/161 (0.62%)  1
Gastrointestinal disorders     
Nausea  1  24/162 (14.81%)  24 1/161 (0.62%)  1
Dyspepsia  1  7/162 (4.32%)  7 0/161 (0.00%)  0
Abdominal Discomfort  1  3/162 (1.85%)  3 1/161 (0.62%)  1
Stomatitis  1  2/162 (1.23%)  2 1/161 (0.62%)  1
Glossodynia  1  0/162 (0.00%)  0 2/161 (1.24%)  2
Flatulence  1  1/162 (0.62%)  1 0/161 (0.00%)  0
Oral Discomfort  1  1/162 (0.62%)  1 0/161 (0.00%)  0
Investigations     
Heart Rate Increased  1  1/162 (0.62%)  1 1/161 (0.62%)  1
Nervous system disorders     
Dizziness  1  4/162 (2.47%)  4 1/161 (0.62%)  1
Headache  1  1/162 (0.62%)  1 1/161 (0.62%)  1
Psychiatric disorders     
Anxiety  1  1/162 (0.62%)  1 1/161 (0.62%)  1
Respiratory, thoracic and mediastinal disorders     
Hiccups  1  13/162 (8.02%)  13 1/161 (0.62%)  1
Throat Irritation  1  5/162 (3.09%)  5 1/161 (0.62%)  1
Nasal Congestion  1  0/162 (0.00%)  0 1/161 (0.62%)  1
Oropharyngeal Pain  1  0/162 (0.00%)  0 1/161 (0.62%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01506908    
Other Study ID Numbers: S7121359
First Submitted: December 15, 2011
First Posted: January 10, 2012
Results First Submitted: December 12, 2013
Results First Posted: January 30, 2014
Last Update Posted: August 28, 2019