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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil AB
• Treatments: Nicotine

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.