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

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

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Nicotine Gum; Drug: Nicotine Patch

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100043
      • Beijing ChaoYang Hospital
    • Beijing, Beijing, China, 100044
      • People's Hospital affiliated to Beijing University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • No. 1 Hospital affiliated to Zhongshan University
    • Guangzhou, Guangdong, China, 510120
      • No. 1 Hospital affiliated to Guangzhou Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Chang Zheng Hospital
    • Shanghai, Shanghai, China, 200032
      • Zhong Shan Hospital affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gum 2; Nicotine Gum 2 mg for subjects smoking less than 20 cigarettes per day; 2 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	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; Other Names: Nicorette® Gum
Experimental: Gum 4; Nicotine Gum 4 mg for subjects smoking 20 or more cigarettes per day; 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	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; Other Names: Nicorette® Gum
Experimental: Patch; 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.	Drug: 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.; Other Names: Nicorette® Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Self-Reported Smoking Reduction	Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day	24 Weeks
Smoking Abstinence	Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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:
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:
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

Collaborators and Investigators

• Sponsor: McNeil AB
• Investigators: Study Chair: Jackie Mao, Shanghai Johnson & Johnson Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 8, 2008
• First Submitted That Met QC Criteria: September 8, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): July 13, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: nicotine dependence, smoking cessation, NRT
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NICTDP4009