Tobacco Dependence
Conditions
Keywords
nicotine dependence, smoking cessation, NRT
Brief summary
To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit
Detailed description
Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral supports.
Interventions
DRUGNicotine Gum
2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks
DRUGNicotine Patch
Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.
Sponsors
McNeil AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy males and females, aged 18 years or older * Normal dental status and chewing ability for nicotine gum users; normal skin without excessive hair growth on tested areas for nicotine patch users * Current daily smoker for at least two years * Have a carbon monoxide (CO) level of at least 10 parts per million (ppm) after at least 15 smoke-free minutes * Be motivated to stop smoking with the help of nicotine gum or patch treatment. * Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the trial * Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Exclusion criteria
* Current use of other tobacco-containing products e.g. snuff, chewing tobacco, cigars, or pipes. * Use of any other stop-smoking products (nicotine or non-nicotine) or treatment (hypnosis, acupuncture, etc) during the study i.e. during the last 6-month period. * Unstable angina pectoris or myocardial infarction during the previous 3 months. * Pregnancy, lactation or intended pregnancy. * Any major metabolic disease, clinically important renal, hepatic disease. * Suspected alcohol or drug abuse. * Participation in other clinical trials in the previous three months, or during study participation. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Related Adverse Events | 24 Weeks | Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher |
| Self-Reported Smoking Reduction | 24 Weeks | Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day |
| Smoking Abstinence | 24 Weeks | Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carbon Monoxide (CO)-Verified Smoking Reduction | Baseline to Week 24 | Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%) |
| Point Prevalence Smoking Abstinence (PPSA) | 24 Weeks | Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment. |
| Smoking Consumption Per Day | 24 Weeks from last visit: | Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers) |
| Smoking Consumption Per Week | 24 Weeks from last visit: | Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers) |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Gum 2 Dosage: 2 mg, Dosage Form: Gum | 86 |
| Nicotine Gum 4 Dosage: 4 mg, Dosage Form: Gum | 64 |
| Nicotine Patch Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch | 150 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Nicotine Gum 2 | Nicotine Gum 4 | Nicotine Patch | Total |
|---|---|---|---|---|
| Age Continuous | 40.6 years STANDARD_DEVIATION 10.2 | 40.3 years STANDARD_DEVIATION 10 | 41.7 years STANDARD_DEVIATION 11.6 | 41.1 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment China | 86 participants | 64 participants | 150 participants | 300 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 86 Participants | 62 Participants | 149 Participants | 297 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 | 22 / 86 | 26 / 64 | 33 / 150 |
| serious Total, serious adverse events | 0 / 86 | 0 / 64 | 0 / 150 |
Outcome results
Primary
Self-Reported Smoking Reduction
Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day
Time frame: 24 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 12 | 80.8 Percentage of Participants | Standard Deviation 24.1 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 6 | 81.0 Percentage of Participants | Standard Deviation 23.6 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 20 | 73.7 Percentage of Participants | Standard Deviation 29.7 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 10 | 80.9 Percentage of Participants | Standard Deviation 24.5 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 8 | 80.8 Percentage of Participants | Standard Deviation 23.5 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 1 | 78.8 Percentage of Participants | Standard Deviation 24.3 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 3 | 81.0 Percentage of Participants | Standard Deviation 22.6 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 2 | 79.9 Percentage of Participants | Standard Deviation 22 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 16 | 76.0 Percentage of Participants | Standard Deviation 27.1 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 4 | 84.2 Percentage of Participants | Standard Deviation 20.1 |
| Nicotine Gum 2 | Self-Reported Smoking Reduction | Week 24 | 72.7 Percentage of Participants | Standard Deviation 31.6 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 8 | 75.4 Percentage of Participants | Standard Deviation 24.6 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 1 | 73.6 Percentage of Participants | Standard Deviation 21.9 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 2 | 73.5 Percentage of Participants | Standard Deviation 21.6 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 3 | 77.3 Percentage of Participants | Standard Deviation 22.2 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 4 | 78.6 Percentage of Participants | Standard Deviation 23.6 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 6 | 78.0 Percentage of Participants | Standard Deviation 22.8 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 10 | 76.0 Percentage of Participants | Standard Deviation 24 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 12 | 77.0 Percentage of Participants | Standard Deviation 22 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 16 | 72.3 Percentage of Participants | Standard Deviation 26.3 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 20 | 69.3 Percentage of Participants | Standard Deviation 28.5 |
| Nicotine Gum 4 | Self-Reported Smoking Reduction | Week 24 | 63.7 Percentage of Participants | Standard Deviation 31 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 20 | 74.0 Percentage of Participants | Standard Deviation 32.6 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 12 | 78.7 Percentage of Participants | Standard Deviation 27.5 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 3 | 79.9 Percentage of Participants | Standard Deviation 23.7 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 1 | 75.2 Percentage of Participants | Standard Deviation 25.1 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 16 | 74.8 Percentage of Participants | Standard Deviation 31.6 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 2 | 77.0 Percentage of Participants | Standard Deviation 24.4 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 8 | 77.1 Percentage of Participants | Standard Deviation 28.9 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 6 | 77.2 Percentage of Participants | Standard Deviation 26.7 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 24 | 71.9 Percentage of Participants | Standard Deviation 34 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 10 | 77.6 Percentage of Participants | Standard Deviation 27.7 |
| Nicotine Patch | Self-Reported Smoking Reduction | Week 4 | 80.3 Percentage of Participants | Standard Deviation 24.2 |
Primary
Smoking Abstinence
Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day
Time frame: 24 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nicotine Gum 2 | Smoking Abstinence | Visit at 2 Weeks | 24 Participants |
| Nicotine Gum 2 | Smoking Abstinence | Visit at 6 Weeks | 19 Participants |
| Nicotine Gum 2 | Smoking Abstinence | Visit at 8 Weeks | 18 Participants |
| Nicotine Gum 2 | Smoking Abstinence | Visit at 10 Weeks | 17 Participants |
| Nicotine Gum 2 | Smoking Abstinence | Visit at 12 Weeks | 16 Participants |
| Nicotine Gum 2 | Smoking Abstinence | Visit at 24 Weeks | 13 Participants |
| Nicotine Gum 4 | Smoking Abstinence | Visit at 24 Weeks | 7 Participants |
| Nicotine Gum 4 | Smoking Abstinence | Visit at 2 Weeks | 9 Participants |
| Nicotine Gum 4 | Smoking Abstinence | Visit at 10 Weeks | 7 Participants |
| Nicotine Gum 4 | Smoking Abstinence | Visit at 12 Weeks | 7 Participants |
| Nicotine Gum 4 | Smoking Abstinence | Visit at 6 Weeks | 7 Participants |
| Nicotine Gum 4 | Smoking Abstinence | Visit at 8 Weeks | 7 Participants |
| Nicotine Patch | Smoking Abstinence | Visit at 6 Weeks | 24 Participants |
| Nicotine Patch | Smoking Abstinence | Visit at 8 Weeks | 24 Participants |
| Nicotine Patch | Smoking Abstinence | Visit at 24 Weeks | 17 Participants |
| Nicotine Patch | Smoking Abstinence | Visit at 10 Weeks | 22 Participants |
| Nicotine Patch | Smoking Abstinence | Visit at 2 Weeks | 34 Participants |
| Nicotine Patch | Smoking Abstinence | Visit at 12 Weeks | 21 Participants |
Primary
Treatment-Related Adverse Events
Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher
Time frame: 24 Weeks
Population: Safety Analysis Set (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nicotine Gum 2 | Treatment-Related Adverse Events | Tachypnoea | 1.2 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Dyspepsia | 1.2 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Hiccups | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Sinus tachycardia | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Eructation | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Dermatitis allergic | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Insomnia | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Gingival ulceration | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Abdominal symptom | 1.2 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Myalgia | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Mouth ulceration | 2.3 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Pruritus | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Abdominal distension | 2.3 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Oral discomfort | 1.2 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Oropharyngeal pain | 8.1 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Diarrhoea | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Retching | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Rash vesicular | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Nausea | 15.1 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Chest discomfort | 1.2 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Dizziness | 1.2 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Subjects with at Least One Treatment-Related AE | 25.6 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Heart rate increased | 0 Percentage of Participants |
| Nicotine Gum 2 | Treatment-Related Adverse Events | Abdominal pain upper | 3.5 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Heart rate increased | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Dizziness | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Abdominal pain upper | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Insomnia | 0 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Hiccups | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Oropharyngeal pain | 7.8 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Abdominal symptom | 0 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Tachypnoea | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Dermatitis allergic | 0 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Subjects with at Least One Treatment-Related AE | 39.1 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Pruritus | 0 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Rash vesicular | 0 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Diarrhoea | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Myalgia | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Dyspepsia | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Eructation | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Sinus tachycardia | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Gingival ulceration | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Mouth ulceration | 0 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Oral discomfort | 0 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Abdominal distension | 0 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Retching | 1.6 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Chest discomfort | 3.1 Percentage of Participants |
| Nicotine Gum 4 | Treatment-Related Adverse Events | Nausea | 21.9 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Chest discomfort | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Myalgia | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Tachypnoea | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Mouth ulceration | 0.6 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Subjects with at Least One Treatment-Related AE | 21.3 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Sinus tachycardia | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Abdominal distension | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Abdominal pain upper | 0.6 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Abdominal symptom | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Diarrhoea | 0.6 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Dyspepsia | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Eructation | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Gingival ulceration | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Nausea | 5.3 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Oral discomfort | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Retching | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Heart rate increased | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Dizziness | 2.0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Insomnia | 1.3 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Hiccups | 0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Oropharyngeal pain | 0.6 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Dermatitis allergic | 8.0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Pruritus | 2.0 Percentage of Participants |
| Nicotine Patch | Treatment-Related Adverse Events | Rash vesicular | 1.3 Percentage of Participants |
Secondary
Carbon Monoxide (CO)-Verified Smoking Reduction
Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)
Time frame: Baseline to Week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Gum 2 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 2 Weeks | 82.3 Percentage of Participants | Standard Deviation 21.1 |
| Nicotine Gum 2 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 6 Weeks | 83.7 Percentage of Participants | Standard Deviation 20.4 |
| Nicotine Gum 2 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 8 Weeks | 86.1 Percentage of Participants | Standard Deviation 18 |
| Nicotine Gum 2 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 10 Weeks | 85.1 Percentage of Participants | Standard Deviation 18.9 |
| Nicotine Gum 2 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 12 Weeks | 84.7 Percentage of Participants | Standard Deviation 19.4 |
| Nicotine Gum 2 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 24 Weeks | 80.4 Percentage of Participants | Standard Deviation 25.5 |
| Nicotine Gum 4 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 24 Weeks | 67.6 Percentage of Participants | Standard Deviation 29.2 |
| Nicotine Gum 4 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 2 Weeks | 76.1 Percentage of Participants | Standard Deviation 20 |
| Nicotine Gum 4 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 10 Weeks | 78.7 Percentage of Participants | Standard Deviation 20 |
| Nicotine Gum 4 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 12 Weeks | 79.5 Percentage of Participants | Standard Deviation 19.8 |
| Nicotine Gum 4 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 6 Weeks | 78.9 Percentage of Participants | Standard Deviation 22.4 |
| Nicotine Gum 4 | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 8 Weeks | 77.4 Percentage of Participants | Standard Deviation 23.4 |
| Nicotine Patch | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 6 Weeks | 81.6 Percentage of Participants | Standard Deviation 21 |
| Nicotine Patch | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 8 Weeks | 81.9 Percentage of Participants | Standard Deviation 23.3 |
| Nicotine Patch | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 24 Weeks | 81.2 Percentage of Participants | Standard Deviation 25.5 |
| Nicotine Patch | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 10 Weeks | 82.9 Percentage of Participants | Standard Deviation 22.2 |
| Nicotine Patch | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 2 Weeks | 80.6 Percentage of Participants | Standard Deviation 19 |
| Nicotine Patch | Carbon Monoxide (CO)-Verified Smoking Reduction | Visit at 12 Weeks | 83.4 Percentage of Participants | Standard Deviation 23.6 |
Secondary
Point Prevalence Smoking Abstinence (PPSA)
Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment.
Time frame: 24 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 12 | 34 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 6 | 31 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 1 | 28 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 10 | 32 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 8 | 33 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 20 | 32 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 2 | 28 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 3 | 33 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 16 | 33 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 4 | 33 Participants |
| Nicotine Gum 2 | Point Prevalence Smoking Abstinence (PPSA) | Week 24 | 32 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 1 | 11 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 3 | 15 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 2 | 13 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 4 | 16 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 6 | 16 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 8 | 16 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 10 | 16 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 12 | 16 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 16 | 17 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 20 | 17 Participants |
| Nicotine Gum 4 | Point Prevalence Smoking Abstinence (PPSA) | Week 24 | 16 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 20 | 55 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 12 | 60 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 2 | 43 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 3 | 50 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 16 | 53 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 1 | 42 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 8 | 50 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 6 | 45 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 24 | 57 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 10 | 51 Participants |
| Nicotine Patch | Point Prevalence Smoking Abstinence (PPSA) | Week 4 | 55 Participants |
Secondary
Smoking Consumption Per Day
Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)
Time frame: 24 Weeks from last visit:
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Gum 2 | Smoking Consumption Per Day | 9.5 Cigarettes | Standard Deviation 6.3 |
| Nicotine Gum 4 | Smoking Consumption Per Day | 16.1 Cigarettes | Standard Deviation 8.2 |
| Nicotine Patch | Smoking Consumption Per Day | 11.9 Cigarettes | Standard Deviation 8.2 |
Secondary
Smoking Consumption Per Week
Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)
Time frame: 24 Weeks from last visit:
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Gum 2 | Smoking Consumption Per Week | 25.8 Cigarettes | Standard Deviation 21.4 |
| Nicotine Gum 4 | Smoking Consumption Per Week | 41.6 Cigarettes | Standard Deviation 27.7 |
| Nicotine Patch | Smoking Consumption Per Week | 22.1 Cigarettes | Standard Deviation 24.6 |