Tobacco Use CessationNCT04534231
Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates
An observational study of Tobacco Use Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Nicotine patch
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2020to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary residents of the target municipality
Who may be able to join
- speak and understand English
- 18 years or older
- smoke 10 or more cigarettes per day for at least 3 months
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates: Test of an Idea to Promote Large Increases in Tobacco Cessation
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?
- Conditions
- Tobacco Use Cessation
- Being tested
- Nicotine patch
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called Nicoderm
Nicotine transdermal patches as per product monograph
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day pint prevalence abstinence
No smoking of cigarettes in the past 30 days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start19 Oct 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John A Cunningham, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534231
- Sponsor's protocol ID
- 122/2019
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schell C, Godinho A, Cunningham JA. Investigating if changing the wording of a study invitation letter increased recruitment in a project promoting tobacco cessation in a town with high smoking rates. Subst Abuse Treat Prev Policy. 2026 Jan 27;21(1):15. doi: 10.1186/s13011-026-00704-x.
PubMed 41593728Cunningham JA, Leatherdale ST, Chaiton M, Tyndale RF, Schell C, Godinho A. Concentrated Distribution of Nicotine Patches to a Town With High Smoking Rates-Any Evidence of Large Impacts on Tobacco Cessation? Nicotine Tob Res. 2023 Apr 6;25(5):1060-1061. doi: 10.1093/ntr/ntac244. No abstract available.
PubMed 36264570Cunningham 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates: Test of an Idea to Promote Large Increases in Tobacco Cessation
- ClinicalTrials.gov ID
- NCT04534231
- Acronym / sponsor ID
- 122/2019
- Conditions
- Tobacco Use Cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary residents of the target municipality
Key inclusion criteria (3 listed)
- speak and understand English
- 18 years or older
- smoke 10 or more cigarettes per day for at least 3 months
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchAlso: NicodermNicotine transdermal patches as per product monograph | Drug | – |
Primary outcome
30-day pint prevalence abstinence
Time frame: 6 months
No smoking of cigarettes in the past 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 41593728Schell C, Godinho A, Cunningham JA. Investigating if changing the wording of a study invitation letter increased recruitment in a project promoting tobacco cessation in a town with high smoking rates. Subst Abuse Treat Prev Policy. 2026 Jan 27;21(1):15. doi: 10.1186/s13011-026-00704-x.
- Derived from this study: PubMed 36264570Cunningham JA, Leatherdale ST, Chaiton M, Tyndale RF, Schell C, Godinho A. Concentrated Distribution of Nicotine Patches to a Town With High Smoking Rates-Any Evidence of Large Impacts on Tobacco Cessation? Nicotine Tob Res. 2023 Apr 6;25(5):1060-1061. doi: 10.1093/ntr/ntac244. No abstract available.
- Derived from this study: PubMed 34007899Cunningham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Cunningham, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day pint prevalence abstinence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534231, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.