Targeting Mailed Nicotine Patch Distribution Interventions to Rural Regions of Canada

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

This study will examine the impact of mailed distribution of free Nicotine Replacement Therapy to smokers in rural regions.

Telephone numbers will be randomly selected from across Canada in order to recruit adult smokers interested in completing a smoking survey and willing to be interviewed again in 6 months time.

Study participants will be asked about their smoking history and a hypothetical question: would they be interested in receiving the nicotine patches if this were to be provided to them free of charge?

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

The registry classes the interventions as drug.

More on the Plan

One way of helping people stop smoking is to provide them with free Nicotine Replacement Therapy (NRT; e.g., nicotine patch), such as when NRT is sent to people by postal mail as part of a mass distribution initiative.

A two-stage recruitment process will be employed, in the context of a general population survey with a 6-month follow-up.

Random digit dialling of telephone numbers from rural regions of Canada will identify households with adult (age 18 or over) smokers who smoke 10 or more cigarettes a day and who are willing to take part in a smoking study that involves two interviews.

Residence of participants in rural regions will be confirmed by postal code matching.

Who Took Part

The registry lists 498 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: Smoke 10 or more cigarettes per day. Willing to be interviewed at baseline and 6 months. Interest in using nicotine patch to quit smoking. Intent to use nicotine patch within 1 week of receipt. Willing to have nicotine patches sent to their home.

The full record lists 5 inclusion and 1 exclusion criteria; among the exclusions: contraindication to nrt patch use (e.g. pregnant, intending on becoming pregnant, allergic to tape, serious heart circulation problem, not including high blood pressure).

How the Study Was Run

Design: randomized, parallel-group and single-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.

In this single-blind Therapeutic nicotine (patch, non-peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2020-11-23 with completion listed for 2022-02-16.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 30-day point prevalence abstinence (time frame: 6 month follow-up).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 498 people.

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.