Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery

NCT02918500 | Terminated Phase 4 Results

• 1 other identifier: 20160696-01H
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Smoking Cessation

Keywords

Coronary Artery Bypass Surgery (CABG); Nicotine Replacement Therapy (NRT)

Outcome Measures

Primary Outcomes (1)

• 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

  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

  At the time of surgery and each follow up visit (1 & 6 months post-op)

Other Outcomes (1)

• 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.

  assessed at the 1 and 6 month post-op follow up visits

Study Arms (2)

Placebo

NO INTERVENTION

Participants will receive 3 weeks of inactive NRT patches.

Active

ACTIVE COMPARATOR

Participants will receive 3 weeks of active NRT patches

Drug: Nicoderm Patch

Interventions

Nicoderm Patch DRUG

Nicotine replacement therapy patch

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

Study was terminated early due to recruitment challenges; only 4 participants were recruited. The data for these 4 participants will not be analyzed.

Results Point of Contact

• Title: Dr. Andrew Pipe
• Organization: University of Ottawa Heart Institute

apipe@ottawaheart.ca

613-696-7000

Study Officials

• Andrew Pipe, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 29, 2016
• Study Start: October 23, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: January 5, 2022
• Results First Posted: December 6, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)