Back to results

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

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Nicotine Gum

Nicotine Patch

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring nicotine dependence, smoking cessation, NRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing ChaoYang Hospital
People's Hospital affiliated to Beijing University
No. 1 Hospital affiliated to Zhongshan University
No. 1 Hospital affiliated to Guangzhou Medical University
Chang Zheng Hospital
Zhong Shan Hospital affiliated to Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Gum 2

Gum 4

Patch

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Self-Reported Smoking Reduction

Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day

Smoking Abstinence

Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day

Secondary Outcome Measures

Carbon Monoxide (CO)-Verified Smoking Reduction

Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)

Smoking Consumption Per Day

Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)

Smoking Consumption Per Week

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)

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.

Full Information

NCT ID

NCT00749463

First Posted

September 8, 2008

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT00749463

Brief Title

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

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McNeil AB

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Dependence

Keywords

nicotine dependence, smoking cessation, NRT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gum 2

Arm Type

Experimental

Arm Description

Arm Title

Gum 4

Arm Type

Experimental

Arm Description

Arm Title

Patch

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

Nicotine Gum

Other Intervention Name(s)

Nicorette® Gum

Intervention Description

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

Intervention Name(s)

Nicotine Patch

Other Intervention Name(s)

Nicorette® Patch

Intervention Description

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.

Primary Outcome Measure Information:

Title

Treatment-Related Adverse Events

Description

Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher

Time Frame

24 Weeks

Title

Self-Reported Smoking Reduction

Description

Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day

Time Frame

24 Weeks

Title

Smoking Abstinence

Description

Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day

Time Frame

24 Weeks

Secondary Outcome Measure Information:

Title

Carbon Monoxide (CO)-Verified Smoking Reduction

Description

Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)

Time Frame

Baseline to Week 24

Title

Smoking Consumption Per Day

Description

Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)

Time Frame

24 Weeks from last visit:

Title

Smoking Consumption Per Week

Description

Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)

Time Frame

24 Weeks from last visit:

Title

Point Prevalence Smoking Abstinence (PPSA)

Description

Time Frame

24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jackie Mao

Organizational Affiliation

Shanghai Johnson & Johnson Pharmaceuticals

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing ChaoYang Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100043

Country

China

Facility Name

People's Hospital affiliated to Beijing University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

No. 1 Hospital affiliated to Zhongshan University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

No. 1 Hospital affiliated to Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

Chang Zheng Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200003

Country

China

Facility Name

Zhong Shan Hospital affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs