Targeting Mailed Nicotine Patch Distribution Interventions to Rural Regions of Canada

January 16, 2023 updated by: John Cunningham, Centre for Addiction and Mental Health

Targeting Mailed Nicotine Patch Distribution Interventions to Rural Regions of Canada: Randomized Controlled Trial

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? Participants expressing interest will be randomly assigned to one of two groups. One group will be offered the opportunity to actually receive a program of 5 weeks of the nicotine patch for free right away and the other group will not be offered the free nicotine patches. The proportions of smokers in the two groups who quit smoking by the 6-month interview will be compared. Characteristics of the participants and the municipalities in which they live will be used to explain why the nicotine patch intervention has a larger impact in some rural regions compared to others

This projects seeks to determine the impact of mailed NRT intervention on increasing quit rates in rural areas. In addition, it seeks to understand the social determinants of health driving the large effects expected based on previous findings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Quitting smoking is the most effective way of reducing the risk of cancer. 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. Our previous research indicated that the impact of the mailed NRT intervention on increasing quit rates in rural areas may be substantial. The current research project seeks to confirm this finding and to understand the social determinants of health driving these anticipated large effects. This information is essential in order to target limited health resources to regions that are most in need, and who are likely to experience the greatest benefit.

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. As part of the baseline survey, eligible subjects will be identified for the second recruitment - randomization of smokers into experimental and control conditions to be offered versus not offered Nicotine Patches. A randomized half of the eligible participants will be assigned to the experimental condition and asked for their permission to have Nicotine Patches sent to their home. The 6-month follow-up survey will be conducted 6-months after the baseline survey.

The primary hypothesis is that participants receiving the NRT package will display significantly greater quit rates (30 day abstinence) at 6-month follow-up as compared to those not offered the NRT package.

Study Type

Interventional

Enrollment (Actual)

498

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindication to NRT patch use (e.g. pregnant, intending on becoming pregnant, allergic to tape, serious heart circulation problem, not including high blood pressure)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Nicotine Replacement Therapy
Drug: Nicotine patch
Nicotine transdermal patches as per product monograph
Other Names:
  • Nicoderm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day point prevalence abstinence
Time Frame: 6 month follow-up
Self-reported no smoking of cigarettes in the past 30 days
6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Cunningham John, PhD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2020

Primary Completion (Actual)

February 16, 2022

Study Completion (Actual)

October 14, 2022

Study Registration Dates

First Submitted

October 24, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 006/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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