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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT00749463
First received: September 8, 2008
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Tobacco Dependence
Drug: Nicotine Gum
Drug: Nicotine Patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Treatment-Related Adverse Events [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day

  • Smoking Abstinence [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day


Secondary Outcome Measures:
  • Carbon Monoxide (CO)-Verified Smoking Reduction [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)

  • Smoking Consumption Per Day [ Time Frame: 24 Weeks from last visit: ] [ Designated as safety issue: No ]
    Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)

  • Smoking Consumption Per Week [ Time Frame: 24 Weeks from last visit: ] [ Designated as safety issue: No ]
    Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)

  • Point Prevalence Smoking Abstinence (PPSA) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Nicorette® 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749463

Locations
China, Beijing
Beijing ChaoYang Hospital
Beijing, Beijing, China, 100043
People's Hospital affiliated to Beijing University
Beijing, Beijing, China, 100044
China, Guangdong
No. 1 Hospital affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
No. 1 Hospital affiliated to Zhongshan University
Guangzhou, Guangdong, China, 510080
China, Shanghai
Chang Zheng Hospital
Shanghai, Shanghai, China, 200003
Zhong Shan Hospital affiliated to Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
McNeil AB
Investigators
Study Chair: Jackie Mao Shanghai Johnson & Johnson Pharmaceuticals
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT00749463     History of Changes
Other Study ID Numbers: NICTDP4009
Study First Received: September 8, 2008
Results First Received: April 23, 2010
Last Updated: July 6, 2012
Health Authority: China: Ethics Committee

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
nicotine dependence, smoking cessation, NRT

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014