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This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower dose Nicotine | Active Comparator | lower dose nicotine lozenge |
|
| Higher dose Nicotine | Active Comparator | higher dose Nicotine lozenge |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine lower dose | Drug | lower dose nicotine lozenge |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers | 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. | Baseline, 1, 3, 5, 10 and 15 minutes post-treatment |
| Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers | 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. | Baseline, 3 minutes and 15 minutes post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group | Responders 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Clinical Trials | Burbank | California | 91505 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29663982 | Derived | Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo Lozenge (Heavy Smokers Group) | Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route. |
| FG002 | 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. |
| FG003 | Placebo Lozenge (Light Smokers Group) | Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Lozenge 4 mg (Heavy Smokers Group) | Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route. |
| BG001 | Placebo Lozenge 1 (Heavy Smokers Group) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers | 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. | 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. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 1, 3, 5, 10 and 15 minutes post-treatment |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Nicotine higher dose |
| Drug |
higher dose nicotine lozenge |
|
| Placebo | Drug | placebo |
|
| Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm |
| Number of Participants With Adverse Events (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. 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. | Baseline, 0 minute, 60 minutes and 5 days post treatment |
Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
| BG002 | 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. |
| BG003 | Placebo Lozenge 2 (Light Smokers Group) | Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Nicotine cravings assessment baseline scores on a Visual Analogue scale (VAS) | Participants were prohibited from smoking for 4 hours and then exposed to a provoked craving paradigm. During the provoked craving paradigm subjects were exposed to the sight and smell of a lit cigarette and were forbidden from putting the cigarette in their mouth. Cravings assessment was completed at the start of and immediately following the provoked craving paradigm using a VAS. | Mean | Standard Deviation | Score on a scale |
|
Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
| OG001 | Placebo Lozenge 2 (Light Smokers Group) | Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route. |
|
|
|
| Primary | Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers | 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. | ITT population: All randomized participants who had at least one cravings assessment measurement post dose. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 3 minutes and 15 minutes post-treatment |
|
|
|
|
| Secondary | Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group | Responders 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. | Posted | Number | percentage | Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm |
|
|
|
| Secondary | Number of Participants With Adverse Events (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. 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. | Safety population: All randomized participants who received the study treatments were considered evaluable for safety. | Posted | Number | participants | Baseline, 0 minute, 60 minutes and 5 days post treatment |
|
|
|
| 0 |
| 60 |
| 1 |
| 60 |
| EG001 | Nicotine Lozenge 4mg (Heavy Smokers Group) | Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route. | 0 | 52 | 11 | 52 |
| EG002 | Placebo Lozenge 1 (Heavy Smokers Group) | Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route. | 0 | 34 | 0 | 34 |
| EG003 | Placebo Lozenge 2 (Light Smokers Group) | Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route. | 0 | 41 | 1 | 41 |
| Oral discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
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.
| D006573 |
| Heterocyclic Compounds, 1-Ring |
Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing. |
| ANCOVA |
| 0.0547 |
| Least square mean difference |
| -9.70 |
| 2-Sided |
| 95 |
| -19.59 |
| 0.20 |
Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level. |
| Superiority or Other |
| SAE |
|