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CompletedNCT04534231Updated Aug 31, 2021

Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates

An observational study in Tobacco Use Cessation, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by Centre for Addiction and Mental Health · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
123
Ages
18 Years and older
Sex
All
01

Study summary

One municipality with high smoking rates will be selected. A coupon for free-of-charge nicotine patches will be sent to each household. Reductions in the number of people smoking in the chosen municipality from before to after the NRT distribution will be estimated

Read the detailed description

A coupon offering five weeks of free nicotine patches will be mailed to every household in a small municipality with elevated smoking rates. Up to 800 participants (one per household) will be able to redeem their coupon online or by phone, and receive nicotine patches via postal mail. Participants will be asked to complete a baseline survey containing items relevant to predicting smoking cessation. Participants will be asked to complete a six-month follow-up survey to assess changes in smoking status.

Research Question: Will the concentrated distribution of nicotine patches in a region of high smoking rates lead to large reductions in smoking rates?

02

Conditions studied

  • Tobacco Use Cessation
03

In context

Lead sponsor

Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary residents of the target municipality

Inclusion criteria

  • speak and understand English
  • 18 years or older
  • smoke 10 or more cigarettes per day for at least 3 months

Exclusion criteria

Exclusion Criteria:

  • health contraindications for using nicotine patches without supervision of a doctor (e.g. allergy to tape, pregnant or intending to become pregnant, currently breastfeeding, serious heart or circulation problems not including high blood pressure)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
123 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Interventions

  • DrugNicotine patch

    Nicotine transdermal patches as per product monograph

    Also known as: Nicoderm

06

What researchers measure

Primary outcomes

  1. 30-day pint prevalence abstinence

    No smoking of cigarettes in the past 30 days

    Time frame: 6 months

07

Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M5S 2S1, Canada
08

References and documents

Publications

  • Cunningham JA, Leatherdale ST, Chaiton M, Tyndale RF, Schell C, Godinho A. Offering nicotine patches to all households in a community with high smoking rates: Pilot test of a population-based approach to promote tobacco cessation. Int J Popul Data Sci. 2021 Feb 11;6(1):1400. doi: 10.23889/ijpds.v6i1.1400. PubMed 34007899 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04534231
Lead sponsor
Centre for Addiction and Mental Health
Responsible party
John Cunningham (Senior Scientist, Centre for Addiction and Mental Health) — Principal investigator
First posted
Sep 1, 2020
Start date
Oct 19, 2020
Primary completion
Aug 30, 2021
Completion
Aug 30, 2021
Last update
Aug 31, 2021

Study contacts

John A Cunningham, PhD
principal investigator · Centre for Addiction and Mental Health

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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