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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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
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.
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, China
People's Hospital affiliated to Beijing University
Beijing, Beijing Municipality, China
No. 1 Hospital affiliated to Zhongshan University
Guangzhou, Guangdong, China
No. 1 Hospital affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
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
Self-Reported Smoking Reduction
Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day
Time frame: 24 Weeks
Smoking Abstinence
Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day
Time frame: 24 Weeks
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
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:
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:
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.
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Chang Zheng Hospital
Shanghai, Shanghai Municipality, China
Zhong Shan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Time frame: 24 Weeks