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

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had three arms (groups): Gum 2 (experimental), Gum 4 (experimental) and Patch (experimental).

The registry classes the interventions as drug.

More on the Plan

During the study, brief telephone consultation and SMS are provided as behavioral supports.

Who Took Part

The registry lists 300 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-02 with completion listed for 2009-11.

It ran at 6 sites in China (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Treatment-Related Adverse Events (time frame: 24 Weeks). Smoking Abstinence (time frame: 24 Weeks).

It also tracked 4 secondary outcomes, for example Smoking Consumption Per Day, Smoking Consumption Per Week and Point Prevalence Smoking Abstinence (PPSA).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Therapeutic nicotine (patch, non-peptide) in 300 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.