Genetically Informed Smoking Cessation Trial

What Was Tested

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

The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information.

Smokers try to quit smoking but relapses are common.

It had three arms (groups): Combination NRT and Counseling (active comparator), Varenicline (Chantix) and Counseling (active comparator) and one (placebo comparator).

Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.

Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.

Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.

The registry classes the interventions as behavioral and drug.

More on the Plan

The investigators propose a prospective, genotype-based stratified randomization trial to compare two smoking cessation medications (combination NRT \[patch and lozenge\], varenicline vs. placebo) for 3 months in 720 smokers with known genotypes.

Who Took Part

The registry lists 822 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Adult (≥21 years of age), seeking treatment for smoking cessation. Able to speak English,. Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm. Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: pregnancy or breast feeding,; allergy to nicotine patch, lozenge, or varenicline,; current heavy alcohol consumption (≥6 drinks/day, 6 days/week),.

How the Study Was Run

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

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

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 2015-05-20 with completion listed for 2018-12-26.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: 7-day Point Prevalence Quit Rate (time frame: Week 12).

It also tracked 10 secondary outcomes, for example Continuous Abstinence, 7-day Point Prevalence Quit Rate, Number of Days to Lapse, Number of Days to Relapse, Initial Cessation and Longitudinal Models of Abstinence Outcomes Across Multiple Time Points.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 822 people.

With 822 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.