Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nicotine · 10 trials · 4 indications
Participants completed a cigarette craving assessment consisting of the 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 craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.
Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration 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 was measured.
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.
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.
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.
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Cmax for 2 mg test was compared with 2 mg reference gum
Cmax for 4 mg test was compared with 4 mg reference gum
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.
AUC(0-t) was evaluated using the trapezoid rule.
Cmax was depicted from plasma concentration of nicotine.
Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands
| Arm | Type | Description |
|---|---|---|
| Nicotine Mouth Film | EXPERIMENTAL | mint nicotine mouth film, buccal administration |
| Nicotine Lozenge | ACTIVE_COMPARATOR | nicotine lozenge, buccal administration |
| 2mg nicotine lozenge | EXPERIMENTAL | 2 mg nicotine lozenge |
| 2 mg placebo | PLACEBO_COMPARATOR | 2 mg placebo |
| 4 mg nicotine lozenge | EXPERIMENTAL | 4 mg nicotine lozenge |
| 4 mg placebo | PLACEBO_COMPARATOR | 4 mg placebo |
| Prototype 1 | EXPERIMENTAL | 4mg nicotine lozenge administered orally as a single dose treatment per subject |
| Prototype 2 | EXPERIMENTAL | 4mg nicotine lozenge administered orally as a single dose treatment per subject |
| Prototype 3 | EXPERIMENTAL | 4mg nicotine lozenge administered orally as a single dose treatment per subject |
| Reference Therapy | ACTIVE_COMPARATOR | 4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject. |
| Nicotine mouth strip | EXPERIMENTAL | single dose |
| nicotine gum | ACTIVE_COMPARATOR | single dose |
| Nicotine Polacrilex mint mini lozenge | ACTIVE_COMPARATOR | - |
| placebo | PLACEBO_COMPARATOR | mint mini lozenge with no active |
| Lower dose Nicotine | ACTIVE_COMPARATOR | lower dose nicotine lozenge |
| Higher dose Nicotine | ACTIVE_COMPARATOR | higher dose Nicotine lozenge |
| Test nicotine gum (2 mg) | EXPERIMENTAL | A single dose of Nicotine Mint Gum (2 mg) to be chewed. |
| Test nicotine gum (4 mg) | EXPERIMENTAL | A single dose of Nicotine Mint Gum (4 mg) to be chewed. |
| Reference nicotine gum (2 mg) | ACTIVE_COMPARATOR | A single dose of reference nicotine gum (2 mg) to be chewed. |
| Reference nicotine gum (4 mg) | ACTIVE_COMPARATOR | A single dose of reference nicotine gum (4 mg) to be chewed. |
| Reference | ACTIVE_COMPARATOR | nicotine transdermal patch with the existing polyisobutylene adhesive |
| Treatement | ACTIVE_COMPARATOR | nicotine transdermal patch with the alternate polyisobutylene adhesive |
| Test nicotine lozenge (2 mg) | EXPERIMENTAL | 2 mg test nicotine lozenge to be chewed. |
| Test nicotine lozenge (4 mg) | EXPERIMENTAL | 4 mg test nicotine lozenge to be chewed. |
| Reference nicotine lozenge (2 mg) | ACTIVE_COMPARATOR | 2 mg reference nicotine lozenge to be chewed. |
| Reference nicotine lozenge (4 mg) | ACTIVE_COMPARATOR | 4 mg reference nicotine lozenge to be chewed. |
| Marketed formulation | ACTIVE_COMPARATOR | Marketed nicotine replacement therapy product |
| prototype | EXPERIMENTAL | Nicotine prototype |
| Name | Type | Description |
|---|---|---|
| Nicotine | DRUG | Comparison of different dosage forms of nicotine |
| Placebo | DRUG | placebo lozenge |
| oral nicotine | DRUG | oral nicotine replacement product |
| Nicotine lower dose | DRUG | lower dose nicotine lozenge |
| Nicotine higher dose | DRUG | higher dose nicotine lozenge |
| Nicotine (2 mg) | DRUG | 2 mg nicotine gum in two formulations |
| Nicotine (4 mg) | DRUG | 4 mg nicotine gum in two formulations |
Inclusion Criteria: * BMI within the range of 19-35 kg/m2; * Current cigarette smokers who have smoked regularly daily for at least a year, * Participants who smoke their first cigarette more than 30 minutes after waking up Exclusion Criteria: * Known or suspected intolerance or hypersensitivity ...
Nicotine is an investigational small molecule being developed by GSK plc for smoking cessation. It is being studied in healthy volunteer smokers and individuals with smoking dependence. The drug is intended to help people stop smoking, and it is currently in clinical development.
Nicotine is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. GSK is conducting clinical trials to evaluate nicotine as a smoking cessation aid.
Nicotine is in Phase 1 clinical development. While some completed trials were Phase 2, the overall development program is currently in Phase 1. Nicotine is investigational and has not been approved by regulatory authorities for smoking cessation.
Nicotine has been studied in five completed clinical trials, including NCT01476202, NCT01536704, NCT01669122, and NCT01847443. These trials evaluated nicotine lozenges and gum formulations for smoking cessation in healthy volunteers across the United States, India, and the United Kingdom.
Nicotine is the active ingredient in nicotine replacement therapy (NRT) products. The clinical trials listed for this drug, such as NCT01476202, evaluate nicotine as a form of NRT for smoking cessation, comparing different formulations like lozenges and gum.