Phase I Study: Stop Smoking Therapy for Ontario Patients (STOP)

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

There was a decline in smoking prevalence from 1995 but it has remained unchanged since 2002.

This rate of smoking cessation has not kept up with the rest of Canada.

It had 1 arm (groups): NRT + Behavioural Support (experimental).

Nicotine Replacement Therapy plus Behavioural Intervention.

The registry classes the interventions as behavioral and drug.

More on the Plan

(US Surgeon General's Report, 1990, p.vi).

Most smoking cessation interventions cost less per year of life saved than most widely accepted medical practices.

Therefore, the USHHS guidelines call for the coverage of these medications.

Therefore, some insurers, both public and private, reimburse patients for stop smoking medications.

Who Took Part

The registry lists 6009 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: Older than or equal to 18 years of age. Current daily smokers who smoke \>10 cigarettes per day. Smoked more than 100 cigarettes in their lifetime.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: current treatment with varenicline; allergic to adhesive; intolerant to nicotine replacement therapy.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-10 with completion listed for 2018-03-30.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Count of Participants Not Smoking (time frame: 6 months post treatment).

It also tracked 1 secondary outcome, for example Count of Participants Not Smoking.

What This Means in Plain Language

Put simply, this is a not phased trial of Therapeutic nicotine (patch, non-peptide) in 6009 people.

With 6009 participants it is a large trial for this field.

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.