Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers

What Was Tested

In this phase 3 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Standard Smoking Cessation (active comparator) and Extended Nicotine Replacement Therapy (experimental).

Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.

The registry classes the interventions as drug and other.

More on the Plan

BACKGROUND Smokers with chronic obstructive pulmonary disease (COPD) recognize the dangers of continued smoking and would like to quit, but for most of them the idea of going 'cold turkey' is too intimidating.

Many of these smokers would like to cut back on the amount that they smoke as part of a longer term path to quitting.

Long-term nicotine replacement therapy (NRT) might allow them to do this.

METHODS In this study, the researchers will randomize 398 smokers with COPD to one of two treatment arms: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT).

Who Took Part

398 actual participants took part.

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

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

Examples of who could join: 18 years of age or older. Smoke 5 or more cigarettes/day. Smoke cigarettes on 25 or more of the last 30 days. Speak either English or Spanish. Willing to take nicotine replacement therapy for up to 1 year and participate in study procedures.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: reside in a facility that does not allow smoking; don't have an address and telephone; unstable cardiac condition (e.g. unstable angina or myocardial infarction in the past 30 days).

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2014-05 with completion listed for 2016-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Smoking Abstinence (Point Prevalent) (time frame: Month 12).

It also tracked 15 secondary outcomes, for example Sustained Abstinence, Quit Attempts, Average Cigarettes Per Day, Carbon Monoxide Exposure, Carcinogen Exposure and Respiratory Function.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 398 people.

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.