Smoking Cessation
Conditions
Keywords
craving, provoked craving, smoking cessation, nicotine replacement therapy, NRT
Brief summary
This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.
Interventions
DRUGnicotine
nicotine in the form of a mouth strip, lozenge and gum
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
* Smoking Status: Current cigarette smokers who have smoked regularly for at least a year and smoke their first cigarette more than 30 minutes after waking up.
Exclusion criteria
* Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation. * Prior Concomitant Medication: a. Treatment with known enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit. b. Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit. c. Use of any over-the-counter (OTC) medication that affects central nervous system such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit. d. Use of any nicotine replacement therapy or any other treatment for smoking cessation (e.g. bupropion or varenicline) within one month of screening visit. e. Use of any nicotine containing products at any time during the Provocation/Treatment visit. f. Use of any medications noted in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Nicotine Craving Score on a VAS | Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration | AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
Of 140 screened participants, 120 were randomized while 17 participants were screen failures, and 3 participants were not randomized due to other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Mouth Strip 2.5 mg Participants self administered a single dose of 2.5 mg nicotine mouth strip. | 40 |
| Nicotine Lozenge 2 mg Participants self administered a single dose of 2 mg nicotine lozenge. | 40 |
| Nicotine Gum 2 mg Participants self administered a single dose of 2 mg nicotine lozenge. | 40 |
| Total | 120 |
Baseline characteristics
| Characteristic | Nicotine Mouth Strip 2.5 mg | Nicotine Lozenge 2 mg | Nicotine Gum 2 mg | Total |
|---|---|---|---|---|
| Age Continuous | 35.5 Years STANDARD_DEVIATION 11.4 | 34.8 Years STANDARD_DEVIATION 10.9 | 37.4 Years STANDARD_DEVIATION 11.5 | 35.0 Years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 27 Participants | 72 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 13 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 40 | 4 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Mean Change From Baseline in Nicotine Craving Score on a VAS
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: Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration
Population: Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 7 minutes | -39.0 Score on a scale | Standard Deviation 33.2 |
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 30 minutes | -45.2 Score on a scale | Standard Deviation 35.3 |
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 15 minutes | -45.2 Score on a scale | Standard Deviation 33.3 |
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 10 minutes | -43.9 Score on a scale | Standard Deviation 31.8 |
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 50 seconds | -11.3 Score on a scale | Standard Deviation 17.2 |
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 25 minutes | -47.3 Score on a scale | Standard Deviation 33.8 |
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 5 minutes | -35.8 Score on a scale | Standard Deviation 31 |
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 3 minutes | -28.2 Score on a scale | Standard Deviation 28.8 |
| Nicotine Mouth Strip 2.5 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 20 minutes | -47.9 Score on a scale | Standard Deviation 30 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 10 minutes | -30.0 Score on a scale | Standard Deviation 26 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 50 seconds | -1.7 Score on a scale | Standard Deviation 6 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 3 minutes | -12.0 Score on a scale | Standard Deviation 20.7 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 5 minutes | -18.3 Score on a scale | Standard Deviation 22.8 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 7 minutes | -25.5 Score on a scale | Standard Deviation 27.2 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 15 minutes | -34.4 Score on a scale | Standard Deviation 29.1 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 20 minutes | -37.4 Score on a scale | Standard Deviation 30.1 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 25 minutes | -40.7 Score on a scale | Standard Deviation 30.9 |
| Nicotine Lozenge 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 30 minutes | -42.8 Score on a scale | Standard Deviation 32.1 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 5 minutes | -27.2 Score on a scale | Standard Deviation 24 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 50 seconds | -4.6 Score on a scale | Standard Deviation 9 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 20 minutes | -42.7 Score on a scale | Standard Deviation 31.6 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 3 minutes | -17.6 Score on a scale | Standard Deviation 18.4 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 30 minutes | -42.3 Score on a scale | Standard Deviation 31 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 10 minutes | -38.4 Score on a scale | Standard Deviation 29.9 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 7 minutes | -33.8 Score on a scale | Standard Deviation 27.5 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 25 minutes | -43.5 Score on a scale | Standard Deviation 29.7 |
| Nicotine Gum 2 mg | Mean Change From Baseline in Nicotine Craving Score on a VAS | 15 minutes | -40.2 Score on a scale | Standard Deviation 30.7 |
Secondary
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.
Time frame: Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration
Population: Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on LOCF technique.
| Arm | Measure | Group | Value (LOG_MEAN) |
|---|---|---|---|
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-7 minutes) | 5.8 Score on a scale*minutes |
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-30 minutes) | 6.8 Score on a scale*minutes |
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-15 minutes) | 6.3 Score on a scale*minutes |
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-10 minutes) | 6.0 Score on a scale*minutes |
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-50 seconds) | 4.0 Score on a scale*minutes |
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-25 minutes) | 6.7 Score on a scale*minutes |
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-5 minutes) | 5.5 Score on a scale*minutes |
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-3 minutes) | 5.1 Score on a scale*minutes |
| Nicotine Mouth Strip 2.5 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-20 minutes) | 6.5 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-10 minutes) | 6.3 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-50 seconds) | 4.1 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-3 minutes) | 5.3 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-5 minutes) | 5.7 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-7 minutes) | 6.0 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-15 minutes) | 6.6 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-20 minutes) | 6.8 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-25 minutes) | 6.9 Score on a scale*minutes |
| Nicotine Lozenge 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-30 minutes) | 7.1 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-5 minutes) | 5.7 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-50 seconds) | 4.1 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-20 minutes) | 6.7 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-3 minutes) | 5.2 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-30 minutes) | 7.0 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-10 minutes) | 6.2 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-7 minutes) | 5.9 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-25 minutes) | 6.8 Score on a scale*minutes |
| Nicotine Gum 2 mg | Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC (0-15 minutes) | 6.5 Score on a scale*minutes |