Use of the nicotine metabolite ratio as a genetically informed biomarker of response to nicotine patch or varenicline for smoking cessation: a randomised, double-blind placebo-controlled trial

What Was Tested

Researchers studied Therapeutic nicotine (patch, non-peptide) in this randomized controlled trial publication.

The researchers tested whether a genetically informed biomarker of nicotine clearance, the nicotine metabolite ratio (NMR; 3'-hydroxycotinine:cotinine), predicts response to nicotine patch or varenicline for smoking cessation.

National Institutes of Health, Canadian Institutes of Health Research, Abramson Cancer Center, Centre for Addiction and Mental Health Foundation, and Pennsylvania Department of Health.

Who Took Part

According to the abstract, 12 patients were involved.

By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.

Smokers seeking treatment were randomly assigned by baseline NMR status and study site, in blocks of 12 patients (1:1:1 ratio), to 11 weeks of placebo (placebo pill plus placebo patch), nicotine patch (active patch plus placebo pill), or varenicline (active pill plus placebo patch), plus behavioural counselling.

Participants and investigators were masked to group allocation and NMR status.

How the Study Was Run

In design terms this was a randomized, placebo-controlled and multicenter study.

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.

Some patients received a placebo instead of Therapeutic nicotine (patch, non-peptide), giving a reference point.

More than one site took part, so the patients came from several places.

A time span of 12 months appears in the methods.

The researchers undertook NMR-stratified multicentre, randomised, placebo-controlled clinical trial from Nov 16, 2010, to Sept 12, 2014, at four sites.

An intention-to-treat analysis was done.

Participants were followed up for 12 months after the target quit date.

The trial is registered at ClinicalTrials.gov, number NCT01314001.

What Was Measured

The researchers tested whether a genetically informed biomarker of nicotine clearance, the nicotine metabolite ratio (NMR; 3'-hydroxycotinine:cotinine), predicts response to nicotine patch or varenicline for smoking cessation.

PubMed files the paper under topics including Biomarkers, Cotinine, Nicotine, Nicotinic Agonists, Smoking Cessation, Tobacco Use Cessation Devices and Varenicline.

What This Means in Plain Language

The paper is a randomized, placebo-controlled and multicenter study of Therapeutic nicotine (patch, non-peptide) in 12 patients over 12 months.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2015 (The Lancet. Respiratory medicine), a journal based in England.

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