Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease

What Was Tested

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

It had two arms (groups): Varenicline (experimental) and Transdermal Nicotine Patch (experimental).

The registry classes the interventions as drug.

More on the Plan

Currently, nicotine replacement therapy (NRT) is the principal medication used in the program.

Recently, a new medication, varenicline, was approved for smoking cessation in Canada.

This study involves sixty current smokers hospitalized at the UOHI for CHD.

Consenting smokers will be randomly assigned to receive varenicline for 12 weeks or transdermal NRT for 12 weeks.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Smoking at least 10 cigarettes/day in the month prior to admission. Motivated to stop smoking. Geographically available for follow-up visits (i.e., live within 1 hour of the study centre).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: have been using nrt, zyban (or wellbutrin), and/or champix for more than 72 hours; have serious cardiac arrhythmias (e.g., tachycardia), vasospastic disease (e.g., buerger's disease, prinzmetal's variant angina); have severe renal impairment or are on dialysis.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2009-04 with completion listed for 2010-11.

It ran at 1 site in Canada.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The primary outcome will be the self-reported continuous abstinence rate, confirmed by exhaled carbon monoxide levels of 10ppm or below during the last 4 weeks of treatment (Varenicline weeks 9-12 and NRT weeks 8-11) (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example Carbon monoxide confirmed continuous abstinence rate at weeks 24 and 52 and &-day point prevalence of abstinence confirmed by Carbon Monoxide levels.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 50 people.

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.