Smoking CessationNCT03097445
Long-term Effectiveness of Mailed Nicotine Replacement Therapy: A 5-year Follow-up
A study testing Nicotine patch in people with Smoking Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This study will perform a 5-year follow-up survey of participants in a randomized controlled trial that evaluated the effectiveness of providing 5 weeks of free NRT (in the form of the nicotine patch) by expedited postal mail without behavioural assistance to regular adult smokers recruited across Canada interested in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2017to 22 Aug 2019
- Phase
- Interventional
- 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
- 18 years of age and older
- Current daily smokers who smoke 10 or more cigarettes per day
- Interested in being involved in a smoking study
- Willing to be interviewed at baseline, 8 weeks and 6 months after
- Willing to provide a saliva sample for cotinine analysis at each time point
- Interest in using nicotine patch to quit smoking
- Intent to use nicotine patch within one week of receiving it
- Willing to have nicotine patch sent to their home
Who cannot join
- Have a medical condition that would would make participation medically hazardous as determined by the list of contraindications for NRT outlined in the CPS and the NRT package insert
- Pregnant, intending on becoming pregnant, or nursing
Trial locations and contacts
1 site in 1 country.
About this study
This study will perform a 5-year follow-up survey of participants in a randomized controlled trial that evaluated the effectiveness of providing 5 weeks of free NRT (in the form of the nicotine patch) by expedited postal mail without behavioural assistance to regular adult smokers recruited across Canada interested in receiving it (clinicaltrials.gov Identifier: NCT01429129).
Read the detailed description
Our group recently completed a randomized controlled trial evaluating the efficacy of providing 5 weeks of free NRT (in the form of the nicotine patch) by expedited postal mail without behavioural assistance to regular adult smokers recruited across Canada interested in receiving it (clinicaltrials.gov Identifier: NCT01429129). The findings revealed that the provision of free nicotine patches via mail resulted in more than a doubling of 30-day abstinence quit rates at a six-month follow-up compared to the no intervention control group (7.6% versus 3.0%; odds ratio of 2.65). While this trial provided evidence for the effectiveness of nicotine patches as a tobacco cessation aid in real world settings, the findings speak only to the short-term effectiveness of NRT. As evidence for NRT effectiveness has been largely restricted to a final follow-up of 6-12 months after the start of treatment, and relapse to smoking is known to occur beyond this period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term.
Employing a survey research call centre, trained interviewers will contact participants in the original randomized controlled trial, 5 years post-enrollment. A total of 924 subjects will be eligible to be contacted, however intent-to-treat analyses will evaluate outcomes based on all 1000 participants randomized to condition in the original trial. In this 5-year follow-up survey, interviewers will first assess participants' smoking status, the number of cigarettes smoked per day and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: abstinence using 30 day point prevalence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the last follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. The survey component of the proposed study will be conducted over a 2 year period to coincide with the duration of subject recruitment in the original trial. The primary hypothesis is that subjects who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to subjects who did not receive nicotine patches at baseline.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine patch
- Keywords
- Smoking, Nicotine, Nicotine Replacement Therapy, Nicotine Patch, Mass Distribution, Tobacco Control, Cancer Prevention, Randomized Controlled Trial
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called Habitrol® transdermal nicotine patches
mailed 5-week course of Habitrol® transdermal nicotine patches
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Therapy | Experimental | mailed 5 week course of transdermal nicotine patches Receives: Drug: Nicotine patch |
| Control | No intervention | No intervention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
self-reported 30-day point prevalence abstinence
Measured: 5-years post intervention
Secondary outcomes (2)
Prolonged Abstinence
self-reported prolonged 6-month abstinence
Measured: 5 years post intervention
Continuous Abstinence
self-reported continuous > 4 years abstinence
Measured: 5 years post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start4 Jun 2017
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
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 Smoking 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John Cunningham, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097445
- Sponsor's protocol ID
- 216-2005
- Status last verified
- Jan 2020
- First submitted
- 25 Mar 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schell C, Godinho A, Kushnir V, Cunningham JA. To send or not to send: weighing the costs and benefits of mailing an advance letter to participants before a telephone survey. BMC Res Notes. 2018 Nov 15;11(1):813. doi: 10.1186/s13104-018-3920-6.
PubMed 30442187Kushnir V, Selby P, Zawertailo L, Tyndale RF, Leatherdale ST, Cunningham JA. Long-term effectiveness of mailed nicotine replacement therapy: study protocol of a randomized controlled trial 5-year follow-up. BMC Public Health. 2017 Jul 18;18(1):28. doi: 10.1186/s12889-017-4586-z.
PubMed 28720080
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness of Mailed Nicotine Replacement Therapy: A 5-year Follow-up
- ClinicalTrials.gov ID
- NCT03097445
- Acronym / sponsor ID
- 216-2005
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Nicotine, Nicotine Replacement Therapy, Nicotine Patch, Mass Distribution, Tobacco Control, Cancer Prevention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 4 Jun 2017 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 31 Mar 2017 (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 perform a 5-year follow-up survey of participants in a randomized controlled trial that evaluated the effectiveness of providing 5 weeks of free NRT (in the form of the nicotine patch) by expedited postal mail without behavioural assistance to regular adult smokers recruited across Canada interested in receiving it (clinicaltrials.gov Identifier: NCT01429129).
Detailed description
Our group recently completed a randomized controlled trial evaluating the efficacy of providing 5 weeks of free NRT (in the form of the nicotine patch) by expedited postal mail without behavioural assistance to regular adult smokers recruited across Canada interested in receiving it (clinicaltrials.gov Identifier: NCT01429129). The findings revealed that the provision of free nicotine patches via mail resulted in more than a doubling of 30-day abstinence quit rates at a six-month follow-up compared to the no intervention control group (7.6% versus 3.0%; odds ratio of 2.65). While this trial provided evidence for the effectiveness of nicotine patches as a tobacco cessation aid in real world settings, the findings speak only to the short-term effectiveness of NRT. As evidence for NRT effectiveness has been largely restricted to a final follow-up of 6-12 months after the start of treatment, and relapse to smoking is known to occur beyond this period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term.
Employing a survey research call centre, trained interviewers will contact participants in the original randomized controlled trial, 5 years post-enrollment. A total of 924 subjects will be eligible to be contacted, however intent-to-treat analyses will evaluate outcomes based on all 1000 participants randomized to condition in the original trial. In this 5-year follow-up survey, interviewers will first assess participants' smoking status, the number of cigarettes smoked per day and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: abstinence using 30 day point prevalence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the last follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. The survey component of the proposed study will be conducted over a 2 year period to coincide with the duration of subject recruitment in the original trial. The primary hypothesis is that subjects who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to subjects who did not receive nicotine patches at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy | Experimental | Drug: Nicotine patchmailed 5 week course of transdermal nicotine patches |
| Control | No intervention | –No intervention control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age and older
- Current daily smokers who smoke 10 or more cigarettes per day
- Interested in being involved in a smoking study
- Willing to be interviewed at baseline, 8 weeks and 6 months after
- Willing to provide a saliva sample for cotinine analysis at each time point
Key exclusion criteria (2 listed)
- Have a medical condition that would would make participation medically hazardous as determined by the list of contraindications for NRT outlined in the CPS and the NRT package insert
- Pregnant, intending on becoming pregnant, or nursing
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: Habitrol® transdermal nicotine patchesmailed 5-week course of Habitrol® transdermal nicotine patches | Drug | Nicotine Replacement Therapy |
Primary outcome
Smoking Cessation
Time frame: 5-years post intervention
self-reported 30-day point prevalence abstinence
2 secondary outcomes
Prolonged Abstinence
Time frame: 5 years post intervention
Continuous Abstinence
Time frame: 5 years post intervention
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 23 Jan 2020.
- Derived from this study: PubMed 30442187Schell C, Godinho A, Kushnir V, Cunningham JA. To send or not to send: weighing the costs and benefits of mailing an advance letter to participants before a telephone survey. BMC Res Notes. 2018 Nov 15;11(1):813. doi: 10.1186/s13104-018-3920-6.
- Derived from this study: PubMed 28720080Kushnir V, Selby P, Zawertailo L, Tyndale RF, Leatherdale ST, Cunningham JA. Long-term effectiveness of mailed nicotine replacement therapy: study protocol of a randomized controlled trial 5-year follow-up. BMC Public Health. 2017 Jul 18;18(1):28. doi: 10.1186/s12889-017-4586-z.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
- 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 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?
A study testing Nicotine patch in people with Smoking 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 8 inclusion and 2 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 23 Jan 2020. 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?
Smoking Cessation (time frame: 5-years post intervention). 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 NCT03097445, 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 23 Jan 2020.