A Phase 3 interventional study of Nicotine in Smoking Cessation, sponsored by GlaxoSmithKline. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-30.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.
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Exclusion Criteria:
mint nicotine mouth film, buccal administration
Drug: Nicotine
nicotine lozenge, buccal administration
Drug: Nicotine
Comparison of different dosage forms of nicotine
The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds
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.
Time frame: Pre-dosing post-provocation to 50 seconds
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
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 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .
Time frame: Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes
Participants were recruited at the clinical site.
| Milestone | Nicotine Mouth Film 2.5 mg | Nicotine Lozenge 2 mg |
|---|---|---|
| Started | 161 | 161 |
| Safety population | 161 | 160 |
| Completed | 161 | 160 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
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.
| mm | Nicotine Mouth Film 2.5 mg | Nicotine Lozenge 2 mg |
|---|---|---|
| The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds | -14.15 (-16.90 to -11.41) | -9.26 (-12.01 to -6.50) |
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 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .
| mm | Nicotine Mouth Film 2.5 mg | Nicotine Lozenge 2 mg |
|---|---|---|
| Difference in VAS Score at 3 Minutes | -27.02 (-30.64 to -23.39) | -20.30 (-23.93 to -16.67) |
| Difference in VAS Score at 5 Minutes | -33.95 (-37.88 to -30.02) | -28.33 (-32.27 to -24.38) |
| Difference in VAS Score at 7 Minutes | -39.13 (-43.20 to -35.05) | -34.14 (-38.23 to -30.05) |
| Difference in VAS Score at 10 Minutes | -40.94 (-45.08 to -36.80) | -39.16 (-43.31 to -35.01) |
| Difference in VAS Score at 15 Minutes | -42.19 (-46.42 to -37.97) | -42.30 (-46.53 to -38.06) |
| Difference in VAS Score at 20 Minutes | -42.43 (-46.77 to -38.09) | -45.23 (-49.58 to -40.87) |
| Difference in VAS Score at 25 Minutes | -43.16 (-47.55 to -38.78) | -46.27 (-50.67 to -41.88) |
| Difference in VAS Score at 30 Minutes | -43.54 (-48.11 to -38.97) | -47.48 (-52.06 to -42.89) |
Collected over AEs were collected from the start of the sequestration period upto 5 days after the last treament. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nicotine Mouth Film 2.5 mg | — | 0/161 (0%) | 6/161 (3.7%) |
| Nicotine Lozenge 2 mg | — | 0/160 (0%) | 29/160 (18.1%) |
| Event | Nicotine Mouth Film 2.5 mg | Nicotine Lozenge 2 mg |
|---|---|---|
| NauseaGastrointestinal disorders | 1/161 | 14/160 |
| Throat IrritationRespiratory, thoracic and mediastinal disorders | 1/161 | 5/160 |
| HiccupsRespiratory, thoracic and mediastinal disorders | 1/161 | 4/160 |
| DizzinessNervous system disorders | 0/161 | 3/160 |
| Epigastric DiscomfortGastrointestinal disorders | 1/161 | 2/160 |
| Abdominal DiscomfortGastrointestinal disorders | 0/161 | 2/160 |
| Gastroesophageal Reflux DiseaseGastrointestinal disorders | 0/161 | 1/160 |
| HeadacheNervous system disorders | 0/161 | 1/160 |
| FlushingVascular disorders | 0/161 | 1/160 |
| Abdominal Pain UpperGastrointestinal disorders | 1/161 | 0/160 |
| Age, Continuous(Years) | Nicotine Mouth Film 2.5 mg | Nicotine Lozenge 2 mg | Total |
|---|---|---|---|
| Mean | 39.0 ± 12.91 | 39.8 ± 12.64 | 39.4 ± 12.76 |
| Sex: Female, Male(Participants) | Nicotine Mouth Film 2.5 mg | Nicotine Lozenge 2 mg | Total |
|---|---|---|---|
| Female | 89 | 73 | 162 |
| Male | 72 | 87 | 159 |
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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