Tobacco Use CessationPhase 4NCT04606797
Targeting Mailed Nicotine Patch Distribution Interventions to Rural Regions of Canada
A Phase 4 study testing Nicotine patch in people with Tobacco Use Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2020to 14 Oct 2022
- Phase
- Phase 4
- 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
Who may be able to 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
Who cannot join
- Contraindication to NRT patch use (e.g. pregnant, intending on becoming pregnant, allergic to tape, serious heart circulation problem, not including high blood pressure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Therapy | Experimental | Not described Receives: Drug: Nicotine patch |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day point prevalence abstinence
Self-reported no smoking of cigarettes in the past 30 days
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start23 Nov 2020
- Primary completion16 Feb 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 498 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
- Cunningham John, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606797
- Sponsor's protocol ID
- 006/2020
- Status last verified
- Jan 2023
- First submitted
- 24 Oct 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37486633Cunningham 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.
PubMed 33228625
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Mailed Nicotine Patch Distribution Interventions to Rural Regions of Canada: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04606797
- Acronym / sponsor ID
- 006/2020
- Conditions
- Tobacco Use Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 28 Oct 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy | Experimental | Drug: Nicotine patch |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindication to NRT patch use (e.g. pregnant, intending on becoming pregnant, allergic to tape, serious heart circulation problem, 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 | Nicotine Replacement Therapy |
Primary outcome
30-day point prevalence abstinence
Time frame: 6 month follow-up
Self-reported 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 18 Jan 2023.
- Derived from this study: PubMed 37486633Cunningham 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.
- Derived from this study: PubMed 33228625Cunningham 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.
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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.
Cunningham John, 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?
A Phase 4 study testing Nicotine patch in people with 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 5 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 18 Jan 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 point prevalence abstinence (time frame: 6 month follow-up). 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 NCT04606797, which also lists 2 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 18 Jan 2023.