A Phase 4 interventional study of Nicoderm Patch in Smoking Cessation, sponsored by Ottawa Heart Institute Research Corporation. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by Ottawa Heart Institute Research Corporation · Phase 4, Interventional, and Treatment
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
The aim of this project is to
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.
Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 3 weeks of inactive NRT patches.
Participants will receive 3 weeks of active NRT patches
Drug: Nicoderm Patch
Nicotine replacement therapy patch
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
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)
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)
Time frame: At the time of surgery and each follow up visit (1 & 6 months post-op)
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.
Participants will be asked about any post-operative complications and a retrospective chart review will be completed for all participants.
Time frame: assessed at the 1 and 6 month post-op follow up visits
| Milestone | Placebo | Active |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
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
No measurements were reported for this outcome.
Measured by the perceived stress scale (PSS-14)
No measurements were reported for this outcome.
Participants will be asked about any post-operative complications and a retrospective chart review will be completed for all participants.
Results for this outcome have not been posted.
Collected over Adverse events were collected over a period of 8 months (recruitment start to recruitment termination). Participants were monitored for adverse events during their 3 week intervention period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Active | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Placebo | Active | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 1 | 1 | 2 |
| Age, Continuous(years) | Placebo | Active | Total |
|---|---|---|---|
| Mean | 65 (54 to 76) | 70 (57 to 83) | 68.5 (54 to 83) |
| Sex: Female, Male(Participants) | Placebo | Active | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Active | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Active | Total |
|---|---|---|---|
| Canada | 2 | 2 | 4 |
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Plan to share: No
This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Ottawa Heart Institute Research Corporation