Smoking, Smoking Dependence
Conditions
Keywords
craving
Brief summary
Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers
Interventions
DRUGoral nicotine
oral nicotine replacement product
DRUGPlacebo
no active
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year; * Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
Exclusion criteria
* Any disease that may interfere with the absorption, metabolism or excretion of the study product. * A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes | Post-cue baseline,5 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute | Post-cue baseline, 1 minute post treatment administration | 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. |
| Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes | Post-cue Baseline, 3 minutes post treatment administration | 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. |
| Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes | Post-Cue Baseline, 7 minutes post treatment administration | 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. |
| Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes | Post-Cue Baseline, 10 minutes post treatment administration | 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. |
| Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | Baseline to Day 5 post treatment administration | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Lozenge 4 mg Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route. | 162 |
| Matched Placebo Participants received a single dose of matched placebo mint lozenge, through oral route. | 161 |
| Total | 323 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Nicotine Lozenge 4 mg | Matched Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.69 Years STANDARD_DEVIATION 12.13 | 44.45 Years STANDARD_DEVIATION 11.64 | 44.07 Years STANDARD_DEVIATION 11.88 |
| Body Mass Index | 27.79 Kilograms (kg)/ meter (m)^2 STANDARD_DEVIATION 3.73 | 27.56 Kilograms (kg)/ meter (m)^2 STANDARD_DEVIATION 4.05 | 27.67 Kilograms (kg)/ meter (m)^2 STANDARD_DEVIATION 3.89 |
| Sex: Female, Male Female | 75 Participants | 74 Participants | 149 Participants |
| Sex: Female, Male Male | 87 Participants | 87 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 54 / 162 | 12 / 161 |
| serious Total, serious adverse events | 0 / 162 | 0 / 161 |
Outcome results
Primary
Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicotine Lozenge 4 mg | Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes | -41.8 Score on a scale |
| Matched Placebo | Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes | -25.9 Score on a scale |
Comparison: Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutesp-value: <0.000195% CI: [-21.6, -10.2]ANCOVA
Secondary
Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicotine Lozenge 4 mg | Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes | -50.8 Score on a scale |
| Matched Placebo | Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes | -32.9 Score on a scale |
Comparison: 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.p-value: <0.000195% CI: [-24.4, -11.4]ANCOVA
Secondary
Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicotine Lozenge 4 mg | Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute | -17.2 Score on a scale |
| Matched Placebo | Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute | -12.9 Score on a scale |
Comparison: 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.p-value: 0.051195% CI: [-8.4, 0]ANCOVA
Secondary
Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicotine Lozenge 4 mg | Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes | -31.1 Score on a scale |
| Matched Placebo | Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes | -19.6 Score on a scale |
Comparison: 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.p-value: <0.000195% CI: [-16.7, -6.4]ANCOVA
Secondary
Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicotine Lozenge 4 mg | Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes | -48.2 Score on a scale |
| Matched Placebo | Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes | -30.5 Score on a scale |
Comparison: 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.p-value: <0.000195% CI: [-23.8, -11.7]ANCOVA
Secondary
Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)
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
Population: Safety population: All randomized participants who received the study treatments were considered evaluable for safety.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nicotine Lozenge 4 mg | Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | AEs | 12 Participants |
| Nicotine Lozenge 4 mg | Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | Treatment Related AEs | 11 Participants |
| Nicotine Lozenge 4 mg | Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | SAEs | 0 Participants |
| Matched Placebo | Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | AEs | 54 Participants |
| Matched Placebo | Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | Treatment Related AEs | 54 Participants |
| Matched Placebo | Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) | SAEs | 0 Participants |