Smoking CessationPhase 4NCT02918500
Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery
A Phase 4 study testing Nicoderm Patch in people with Smoking Cessation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
This study will determine whether or not patients who use a Nicotine Replacement Therapy (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after their surgery and have fewer post-operative complications 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?
- Nicoderm Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 23 Oct 2017to 31 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is currently smoking >5 cigarettes/day for the past 30 days; there is no evidence that NRT is useful in those who smoke <5cpd.
- Patient is able to participate and willing to provide informed consent; participants will need to follow directions and adhere to the medication usage instructions as outlined in the informed consent document.
- Patients is willing to be contacted by phone for follow up at 1 month and 6 months post-discharge; these time points will assess our final outcome of cessation at 6 months post-discharge.
Who cannot join
- Patient is scheduled for surgery in < 7 days; most patients need to be using NRT consistently for 2 weeks for it to be fully effective.
- Patient is currently using a smoking cessation product (i.e. nicotine containing patch, gum, inhaler, lozenge, spray or nicotine containing electronic cigarette, varenicline, buproprion) or has used a smoking cessation aid consistently for more than 72 consecutive hours with the intent to reduce cigarette consumption or quit smoking within 30 days of the baseline Pre-admission Unit (PAU) visit; this will ensure the effects of the study patches will be assessed without any contamination from other cessation products.
- Patient is willing to refrain from using any other cessation products (nicotine containing patch, gum, inhaler, lozenge, spray, nicotine containing electronic cigarette, varenicline, buproprion) prior to surgery; this will allow us to track the usage and side effects with the study patches.
- Patient is allergic to the adhesive on the nicotine replacement therapy patch.
- Patient is unable to read and understand English or French; study materials will only be supplied in these two languages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pre-operative Nicotine Replacement Therapy on Peri-operative Complications and Long-term Abstinence: A Pilot Placebo-controlled Trial in Patients Undergoing Coronary Artery Bypass Surgery (CABG)
This study will determine whether or not patients who use a Nicotine Replacement Therapy (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after their surgery and have fewer post-operative complications
Read the detailed description
The aim of this project is to
- To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery.
- To determine the effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery.
- To assess, retroactively, the impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay.
We therefore hypothesize that if NRT is given to smokers during the pre-admission period (1-3 weeks prior to surgery), they are more likely to be biochemically abstinent from cigarette smoking 6 months after hospitalization and will experience fewer peri-operative complications
To assess these measures, we have designed a single site, double-blinded randomized controlled trial at the University of Ottawa Heart Institute (UOHI). Patients who are identified as a smoker at their initial visit to the PAU will undergo a baseline assessment and be randomly assigned (1:1) to either active or placebo 21mg NRT patch. They will wear the patch from that baseline visit until the day of their surgery at UOHI. Following their surgery, they will receive a follow up phone call at 1 and 6 months post-discharge. They will complete a series of short questionnaires to assess their smoking status, stress levels and nicotine withdrawal symptoms. Those who identify themselves as being smoke-free will be asked to complete a carbon monoxide breathing test to chemically validate their smoking status. The study protocol will be reviewed by the Research Ethics board at UOHI and all participants will provide written informed consent prior to undertaking any study activities.
- Conditions
- Smoking Cessation
- Being tested
- Nicoderm Patch
- Keywords
- Coronary Artery Bypass Surgery (CABG), Nicotine Replacement Therapy (NRT)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicoderm PatchDrug
Nicotine replacement therapy patch
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Participants will receive 3 weeks of inactive NRT patches. |
| Active | Active comparator | Participants will receive 3 weeks of active NRT patches Receives: Drug: Nicoderm Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Monoxide (CO) Confirmed Abstinence at the Time of Surgery
To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery
Measured: At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op)
Secondary outcomes (1)
The Effect of Pre-operative NRT on Perceived Stress and Symptoms of Nicotine Withdrawal at the Time of Surgery
Measured by the perceived stress scale (PSS-14)
Measured: At the time of surgery and each follow up visit (1 & 6 months post-op)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start23 Oct 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Why it stopped: Due to recruitment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Pipe, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918500
- Sponsor's protocol ID
- 20160696-01H
- Status last verified
- Jan 2022
- First submitted
- 6 Sep 2016
- Last updated
- 5 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Nicotine Replacement Therapy on Peri-operative Complications and Long-term Abstinence: A Pilot Placebo-controlled Trial in Patients Undergoing Coronary Artery Bypass Surgery (CABG)
- ClinicalTrials.gov ID
- NCT02918500
- Acronym / sponsor ID
- 20160696-01H
- Conditions
- Smoking Cessation
- Keywords
- Coronary Artery Bypass Surgery (CABG), Nicotine Replacement Therapy (NRT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment challenges.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 6 Dec 2021
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 determine whether or not patients who use a Nicotine Replacement Therapy (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after their surgery and have fewer post-operative complications
Detailed description
The aim of this project is to
- To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery.
- To determine the effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery.
- To assess, retroactively, the impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay.
We therefore hypothesize that if NRT is given to smokers during the pre-admission period (1-3 weeks prior to surgery), they are more likely to be biochemically abstinent from cigarette smoking 6 months after hospitalization and will experience fewer peri-operative complications
To assess these measures, we have designed a single site, double-blinded randomized controlled trial at the University of Ottawa Heart Institute (UOHI). Patients who are identified as a smoker at their initial visit to the PAU will undergo a baseline assessment and be randomly assigned (1:1) to either active or placebo 21mg NRT patch. They will wear the patch from that baseline visit until the day of their surgery at UOHI. Following their surgery, they will receive a follow up phone call at 1 and 6 months post-discharge. They will complete a series of short questionnaires to assess their smoking status, stress levels and nicotine withdrawal symptoms. Those who identify themselves as being smoke-free will be asked to complete a carbon monoxide breathing test to chemically validate their smoking status. The study protocol will be reviewed by the Research Ethics board at UOHI and all participants will provide written informed consent prior to undertaking any study activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Participants will receive 3 weeks of inactive NRT patches. |
| Active | Active comparator | Drug: Nicoderm PatchParticipants will receive 3 weeks of active NRT patches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is currently smoking >5 cigarettes/day for the past 30 days; there is no evidence that NRT is useful in those who smoke <5cpd.
- Patient is able to participate and willing to provide informed consent; participants will need to follow directions and adhere to the medication usage instructions as outlined in the informed consent document.
- Patients is willing to be contacted by phone for follow up at 1 month and 6 months post-discharge; these time points will assess our final outcome of cessation at 6 months post-discharge.
Key exclusion criteria (5 listed)
- Patient is scheduled for surgery in < 7 days; most patients need to be using NRT consistently for 2 weeks for it to be fully effective.
- Patient is currently using a smoking cessation product (i.e. nicotine containing patch, gum, inhaler, lozenge, spray or nicotine containing electronic cigarette, varenicline, buproprion) or has used a smoking cessation aid consistently for more than 72 consecutive hours with the intent to reduce cigarette consumption or quit smoking within 30 days of the baseline Pre-admission Unit (PAU) visit; this will ensure the effects of the study patches will be assessed without any contamination from other cessation products.
- Patient is willing to refrain from using any other cessation products (nicotine containing patch, gum, inhaler, lozenge, spray, nicotine containing electronic cigarette, varenicline, buproprion) prior to surgery; this will allow us to track the usage and side effects with the study patches.
- Patient is allergic to the adhesive on the nicotine replacement therapy patch.
- Patient is unable to read and understand English or French; study materials will only be supplied in these two languages.
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 |
|---|---|---|
| Nicoderm PatchNicotine replacement therapy patch | Drug | Active |
Primary outcome
Carbon Monoxide (CO) Confirmed Abstinence at the Time of Surgery
Time frame: At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op)
To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery
1 secondary outcome
The Effect of Pre-operative NRT on Perceived Stress and Symptoms of Nicotine Withdrawal at the Time of Surgery
Time frame: At the time of surgery and each follow up visit (1 & 6 months post-op)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Andrew Pipe, MD principal investigator
Ottawa Heart Institute Research Corporation
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 Nicoderm Patch in people with Smoking Cessation, run by Ottawa Heart Institute Research Corporation 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 5 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: stopped early, as of the sponsor's last update on 5 Jan 2022. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Carbon Monoxide (CO) Confirmed Abstinence at the Time of Surgery (time frame: At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2022.