Smoking Cessation
Conditions
Keywords
provoked craving
Brief summary
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.
Interventions
DRUGNicotine
Comparison of different dosage forms of nicotine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 to nicotine (or closely related compounds) or any of the stated ingredients in formulation. * Any participant whose CO level rises during the sequestration period (i.e., the subject's two expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds | Pre-dosing post-provocation to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Pre-dosing post-provocation to 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 . |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
A total of 386 participants were screened of which 322 subjects were randomized into the study. Sixty subjects were screen failures, Two subjects withdrew consent and an additional 2 subjects were not randomized due to other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Mouth Film 2.5 mg Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes). | 161 |
| Nicotine Lozenge 2 mg Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes). | 160 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Nicotine Mouth Film 2.5 mg | Nicotine Lozenge 2 mg | Total |
|---|---|---|---|
| Age, Continuous | 39.0 Years STANDARD_DEVIATION 12.91 | 39.8 Years STANDARD_DEVIATION 12.64 | 39.4 Years STANDARD_DEVIATION 12.76 |
| Sex: Female, Male Female | 89 Participants | 73 Participants | 162 Participants |
| Sex: Female, Male Male | 72 Participants | 87 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 161 | 29 / 160 |
| serious Total, serious adverse events | 0 / 161 | 0 / 160 |
Outcome results
Primary
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
Population: All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds | -14.15 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds | -9.26 mm |
Comparison: Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.p-value: 0.014195% CI: [-8.8, -0.99]ANCOVA
Secondary
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 7 Minutes | -39.13 mm |
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 25 Minutes | -43.16 mm |
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 15 Minutes | -42.19 mm |
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 30 Minutes | -43.54 mm |
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 10 Minutes | -40.94 mm |
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 3 Minutes | -27.02 mm |
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 20 Minutes | -42.43 mm |
| Nicotine Mouth Film 2.5 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 5 Minutes | -33.95 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 20 Minutes | -45.23 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 7 Minutes | -34.14 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 10 Minutes | -39.16 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 15 Minutes | -42.30 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 5 Minutes | -28.33 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 25 Minutes | -46.27 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 30 Minutes | -47.48 mm |
| Nicotine Lozenge 2 mg | The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes | Difference in VAS Score at 3 Minutes | -20.30 mm |