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

NCT ID: NCT00749463

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-11-30

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.

Conditions

Tobacco Dependence

Keywords

nicotine dependence, smoking cessation, NRT

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Nicotine Gum

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Nicotine Gum

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Nicorette® Gum; Nicorette® Patch

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McNeil AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jackie Mao

Role: STUDY_CHAIR

Shanghai Johnson & Johnson Pharmaceuticals

Locations

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

Chang Zheng Hospital

Shanghai, Shanghai Municipality, China

Zhong Shan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

NICTDP4009

Identifier Type: -

Identifier Source: org_study_id