NCT04606797

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
498

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

October 24, 2020

Last Update Submit

January 16, 2023

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

  • 30-day point prevalence abstinence

    Self-reported no smoking of cigarettes in the past 30 days

    6 month follow-up

Study Arms (2)

Nicotine Replacement Therapy

EXPERIMENTAL
Drug: Nicotine patch

Control

NO INTERVENTION

Interventions

Nicotine patchDRUG

Nicotine transdermal patches as per product monograph

Also known as: Nicoderm
Nicotine Replacement Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S2S1, Canada

Location

Related Publications (2)

  • Cunningham JA, Chaiton M, Leatherdale ST, Godinho A, Schell C. Effect of Postal-Mailed Nicotine Patches on Tobacco Cessation Among Smokers in Rural Canada: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2325206. doi: 10.1001/jamanetworkopen.2023.25206.

    PMID: 37486633DERIVED

  • Cunningham JA, Chaiton M, Leatherdale ST, Godinho A, Schell C. Targeting mailed nicotine patch distribution interventions to rural regions of Canada: protocol for a randomized controlled trial. BMC Public Health. 2020 Nov 23;20(1):1757. doi: 10.1186/s12889-020-09810-2.

    PMID: 33228625DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Tobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Cunningham John, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

October 24, 2020

First Posted

October 28, 2020

Study Start

November 23, 2020

Primary Completion

February 16, 2022

Study Completion

October 14, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

CA(1)