Pharmacogenetics of Nicotine Addiction Treatment

What Was Tested

This registered phase 3 trial tested Therapeutic nicotine (patch, non-peptide).

The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.

It had six arms (groups): Placebo (Slow Metabolizers) (placebo comparator), Varenicline (Slow Metabolizers) (active comparator), Transdermal Nicotine (Slow Metabolizers) (active comparator), Placebo (Normal Metabolizers) (placebo comparator) and Varenicline (Normal Metabolizers) (active comparator).

The registry classes the interventions as drug.

More on the Plan

Their prior data indicates that the cytochrome P450 2A6 (CYP2A6) enzyme is critical in the metabolic inactivation of nicotine, and also influences smoking behavior and response to therapies.

With a vision toward translation of their research to practice, the researchers have characterized a genetically-informed biomarker of CYP2A6 activity, specifically the nicotine metabolite ratio (NMR; 3'hydroxycotinine/cotinine), which reflects both CYP2A6 genetic variation and environmental influences on CYP2A6 activity.

Translation of these findings to clinical practice requires validation in a prospective clinical trial comparing alternative therapies for smoking cessation.

Thus, the proposed trial is a prospective, stratified, placebo-controlled, multi-center clinical trial of alternative therapies for smoking cessation treatment in approximately 1,200 smokers.

Who Took Part

The registry lists 1246 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Between the ages of 18-65. Smoke at least 10 cigarettes/day for the past 6 months. Provide a baseline Carbon Monoxide (CO) reading greater than 10ppm at the Intake Session. Are seeking smoking cessation treatment. Plan to live in the area for the next 12 months.

The full record lists 7 inclusion and 38 exclusion criteria; among the exclusions: regular (daily) use of chewing tobacco, snuff or snus; current enrollment or plans to enroll in another smoking cessation or research program in the next 12 months; plan to use other nicotine substitutes or smoking cessation treatments in the next 12 months.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2010-12 with completion listed for 2013-12.

It ran at 4 sites in United States (3) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (time frame: Week 11).

It also tracked 5 secondary outcomes, for example 7-day Point Prevalence Quit Rate at 6-month Follow up Survey, Total Side-Effect Severity Index at Pre-Quit, Total Side-Effect Severity Index at Target Quit Date, Total Side-Effect Severity Index at Week 1 and Total Side-Effect Severity Index at Week 4.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1246 people.

With 1246 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.