Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

Tobacco Dependence Clinical Trial

Official title:

Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749463
• Other study ID #: NICTDP4009
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2008
• Last updated: July 6, 2012
• Start date: February 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Nicotine 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
• Nicotine 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.

Locations

Country	Name	City	State
China	Beijing ChaoYang Hospital	Beijing	Beijing
China	People's Hospital affiliated to Beijing University	Beijing	Beijing
China	No. 1 Hospital affiliated to Guangzhou Medical University	Guangzhou	Guangdong
China	No. 1 Hospital affiliated to Zhongshan University	Guangzhou	Guangdong
China	Chang Zheng Hospital	Shanghai	Shanghai
China	Zhong Shan Hospital affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	24 Weeks	No
Primary	Self-Reported Smoking Reduction	Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day	24 Weeks	No
Primary	Smoking Abstinence	Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day	24 Weeks	No
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 (%)	Baseline to Week 24	No
Secondary	Smoking Consumption Per Day	Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)	24 Weeks from last visit:	No
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)	24 Weeks from last visit:	No
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.	24 Weeks	No