Clinical trial NCT00749463: Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
Official title: Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Dependence
Keywords: nicotine dependence, smoking cessation, NRT
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment-Related Adverse Events
timeFrame: 24 Weeks
measure: Self-Reported Smoking Reduction
timeFrame: 24 Weeks
measure: Smoking Abstinence
timeFrame: 24 Weeks
Secondary outcomes:
measure: Carbon Monoxide (CO)-Verified Smoking Reduction
timeFrame: Baseline to Week 24
measure: Smoking Consumption Per Day
timeFrame: 24 Weeks from last visit:
measure: Smoking Consumption Per Week
timeFrame: 24 Weeks from last visit:
measure: Point Prevalence Smoking Abstinence (PPSA)
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing ChaoYang Hospital
state: Beijing
city: Beijing
country: China
facility: People's Hospital affiliated to Beijing University
state: Beijing
city: Guangzhou
country: China
facility: No. 1 Hospital affiliated to Zhongshan University
state: Guangdong
city: Guangzhou
country: China
facility: No. 1 Hospital affiliated to Guangzhou Medical University
state: Guangdong
city: Shanghai
country: China
facility: Chang Zheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhong Shan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Johnson & Johnson Pharmaceuticals
name: Jackie Mao
role: STUDY_CHAIR
References: