Long-term Effectiveness of Mailed Nicotine Replacement Therapy: A 5-year Follow-up

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Nicotine Replacement Therapy (experimental) and Control (no intervention).

Mailed 5 week course of transdermal nicotine patches.

No intervention control group.

The registry classes the interventions as drug.

More on the Plan

A total of 924 subjects will be eligible to be contacted, however intent-to-treat analyses will evaluate outcomes based on all 1000 participants randomized to condition in the original trial.

In this 5-year follow-up survey, interviewers will first assess participants' smoking status, the number of cigarettes smoked per day and their level of nicotine dependence.

The survey component of the proposed study will be conducted over a 2 year period to coincide with the duration of subject recruitment in the original trial.

Who Took Part

1000 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 and older. Current daily smokers who smoke 10 or more cigarettes per day. Interested in being involved in a smoking study. Willing to be interviewed at baseline, 8 weeks and 6 months after. Willing to provide a saliva sample for cotinine analysis at each time point.

The full record lists 8 inclusion and 2 exclusion criteria; among the exclusions: pregnant, intending on becoming pregnant, or nursing.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

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 and investigator.

It started in 2017-06-04 with completion listed for 2019-08-22.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Smoking Cessation (time frame: 5-years post intervention).

It also tracked 2 secondary outcomes, for example Prolonged Abstinence and Continuous Abstinence.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1000 people.

With 1000 participants it is a large trial for this field.

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.