Comparing the Effectiveness of Combined NRT With Single NRT in Primary Care Clinics in Hong Kong

What Was Tested

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

This is a one-year, two-arm, parallel randomized trial in 20 HK public clinics.

It had two arms (groups): Usual group (active comparator) and Intervention group (active comparator).

The registry classes the interventions as drug.

More on the Plan

However, there have been concerns about its adverse effect on neuropsychiatric and cardiovascular aspects.

Besides, many smokers are reluctant to use it due to fear of its high rate of side effects and being medicalized for smoking cessation.

The target recipients of their smoking cessation service are primarily patients attending public general out-patient clinics (GOPCs) for management of chronic illnesses such as hypertension and diabetes mellitus, as well as patients with episodic complaints.

Hypothesis: Combined NRT gives a higher abstinence rate than single NRT.

Who Took Part

Enrollment: 560 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Current smokers who smoke 10 or more cigarettes a day for at least one year.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: unstable angina; severe cardiac arrhythmia; recent acute myocardial infarction or cerebrovascular accident in preceding 3 months.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2012-12-18 with completion listed for 2018-02-28.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 7-day point-prevalence abstinence rate at 52 weeks after quit date (time frame: at 52 weeks after the agreed quit date).

It also tracked 2 secondary outcomes, for example side effects profiles and 7-day point-prevalence of abstinence rate at 26 weeks after quit date.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 560 people.

With 560 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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