Trial Outcomes & Findings for Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving (NCT NCT01466361)
NCT ID: NCT01466361
Last Updated: 2019-08-28
Results Overview
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 (in mm) was measured.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
Baseline, 1, 3, 5, 10 and 15 minutes post-treatment
Results posted on
2019-08-28
Participant Flow
Participants were recruited at the clinical site.
Participants who smoked more than 5 cigarettes per day were included in the study. Participants were stratified to treatments according to their smoking status: heavy smokers: smoking greater than 20 cigarettes per day and light smokers: smoking between 6 - 20 cigarettes per day.
Participant milestones
| Measure |
Nicotine Lozenge 4 Milligrams (mg) (Heavy Smokers Group)
Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
|
Placebo Lozenge (Heavy Smokers Group)
Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
Nicotine Lozenge 1.5mg (Light Smokers Group)
Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge (Light Smokers Group)
Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
34
|
60
|
41
|
|
Overall Study
COMPLETED
|
52
|
34
|
60
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Baseline characteristics by cohort
| Measure |
Nicotine Lozenge 4 mg (Heavy Smokers Group)
n=52 Participants
Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
|
Placebo Lozenge 1 (Heavy Smokers Group)
n=34 Participants
Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
Nicotine Lozenge 1.5mg (Light Smokers Group)
n=60 Participants
Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
n=41 Participants
Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.1 Years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
45.9 Years
STANDARD_DEVIATION 9.43 • n=7 Participants
|
43.9 Years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
45.0 Years
STANDARD_DEVIATION 10.59 • n=4 Participants
|
45.0 Years
STANDARD_DEVIATION 10.48 • n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Nicotine cravings assessment baseline scores on a Visual Analogue scale (VAS)
Baseline score prior provoked craving paradigm(B1)
|
68.3 Score on a scale
STANDARD_DEVIATION 29.147 • n=5 Participants
|
69.54 Score on a scale
STANDARD_DEVIATION 26.534 • n=7 Participants
|
70.00 Score on a scale
STANDARD_DEVIATION 20.895 • n=5 Participants
|
62.3 Score on a scale
STANDARD_DEVIATION 25.785 • n=4 Participants
|
67.5 Score on a scale
STANDARD_DEVIATION 26.090 • n=21 Participants
|
|
Nicotine cravings assessment baseline scores on a Visual Analogue scale (VAS)
Baseline score post provoked craving paradigm (B2)
|
76.03 Score on a scale
STANDARD_DEVIATION 24.849 • n=5 Participants
|
78.39 Score on a scale
STANDARD_DEVIATION 23.659 • n=7 Participants
|
76.96 Score on a scale
STANDARD_DEVIATION 21.667 • n=5 Participants
|
69.1 Score on a scale
STANDARD_DEVIATION 26.335 • n=4 Participants
|
75.1 Score on a scale
STANDARD_DEVIATION 24.127 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1, 3, 5, 10 and 15 minutes post-treatmentPopulation: Intent to treat (ITT) population: All randomized participants with at least one cravings assessment measurement post dose were analyzed. No data was imputed in case of dropouts or missing data.
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 (in mm) was measured.
Outcome measures
| Measure |
Nicotine Lozenge 1.5mg (Light Smokers Group)
n=60 Participants
Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
n=41 Participants
Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
|
Nicotine Lozenge 1.5mg (Light Smokers Group)
Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
3 minutes
|
-24.42 Score on a scale
Standard Error 3.108
|
-17.26 Score on a scale
Standard Error 3.770
|
—
|
—
|
|
Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
5 minutes
|
-30.19 Score on a scale
Standard Error 3.257
|
-23.86 Score on a scale
Standard Error 3.950
|
—
|
—
|
|
Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
15 minutes
|
-38.99 Score on a scale
Standard Error 3.689
|
-33.99 Score on a scale
Standard Error 4.475
|
—
|
—
|
|
Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
10 minutes
|
-35.33 Score on a scale
Standard Error 3.428
|
-30.23 Score on a scale
Standard Error 4.158
|
—
|
—
|
|
Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
1 minute
|
-15.40 Score on a scale
Standard Error 2.439
|
-8.17 Score on a scale
Standard Error 2.958
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3 minutes and 15 minutes post-treatmentPopulation: ITT population: All randomized participants who had at least one cravings assessment measurement post dose.
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 (in mm) was measured.
Outcome measures
| Measure |
Nicotine Lozenge 1.5mg (Light Smokers Group)
n=52 Participants
Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
n=34 Participants
Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
|
Nicotine Lozenge 1.5mg (Light Smokers Group)
Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers
1 minute
|
-16.82 Score on a scale
Standard Error 2.613
|
-13.24 Score on a scale
Standard Error 3.232
|
—
|
—
|
|
Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers
3 minutes
|
-29.52 Score on a scale
Standard Error 3.124
|
-19.82 Score on a scale
Standard Error 3.865
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigmResponders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.
Outcome measures
| Measure |
Nicotine Lozenge 1.5mg (Light Smokers Group)
n=101 Participants
Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
n=86 Participants
Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
|
Nicotine Lozenge 1.5mg (Light Smokers Group)
Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
|---|---|---|---|---|
|
Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group
|
77.2 percentage
|
75.6 percentage
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0 minute, 60 minutes and 5 days post treatmentPopulation: Safety population: All randomized participants who received the study treatments were considered evaluable for safety.
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. 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.
Outcome measures
| Measure |
Nicotine Lozenge 1.5mg (Light Smokers Group)
n=52 Participants
Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
n=34 Participants
Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
|
Nicotine Lozenge 1.5mg (Light Smokers Group)
n=60 Participants
Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
n=41 Participants
Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
AEs
|
11 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Nicotine Lozenge 1.5mg (Light Smokers Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nicotine Lozenge 4mg (Heavy Smokers Group)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Lozenge 1 (Heavy Smokers Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Lozenge 2 (Light Smokers Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Lozenge 1.5mg (Light Smokers Group)
n=60 participants at risk
Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
|
Nicotine Lozenge 4mg (Heavy Smokers Group)
n=52 participants at risk
Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
|
Placebo Lozenge 1 (Heavy Smokers Group)
n=34 participants at risk
Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
Placebo Lozenge 2 (Light Smokers Group)
n=41 participants at risk
Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
9.6%
5/52 • Number of events 7 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/34 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/41 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/60 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
1.9%
1/52 • Number of events 1 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/34 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/41 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/60 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
1.9%
1/52 • Number of events 1 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/34 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/41 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/60 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
11.5%
6/52 • Number of events 6 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/34 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/41 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/60 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
3.8%
2/52 • Number of events 2 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/34 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
2.4%
1/41 • Number of events 1 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60 • Number of events 1 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/52 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/34 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/41 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
|
Nervous system disorders
Headache
|
0.00%
0/60 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
1.9%
1/52 • Number of events 1 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/34 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
0.00%
0/41 • All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER