PeRiopEratiVE SmokiNg CessaTion Trial

Phase 3

Active, not recruiting

• Conditions: Smoking (Tobacco) Addiction; Smoking Cessation
• Interventions: Drug: Cytisine; Behavioral: Video Messaging

• Registration Number: NCT05102123
• Lead Sponsor: Population Health Research Institute

Brief Summary

PREVENT is a multicentre, 2x2 factorial, randomized clinical trial that aims to determine the effect of cytisine versus placebo, as well as the effect of video messaging to support smoking cessation versus standard of care in perioperative patients. This trial aims to investigate the effects of cytisine and text messaging on 6-month continuous abstinence rates. PREVENT will also assess secondary outcomes at 30 days, 56 days and 6 months post-randomization: 7-day point prevalence abstinence, urge to smoke, time to first lapse, time to relapse, number of cigarettes smoking if still smoking, pulmonary complications, vascular complications, wound and infectious complications, stroke, time in hospital and acute hospital care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-11-01
• Study Start: 2024-01-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2026-07-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1720

Inclusion Criteria

1. are ≥18 years of age
2. are scheduled to undergo surgery within 28 days
3. are a current smoker and not currently using any smoking cessation treatment and,
4. have a smart mobile phone with an active, up to date data plan and with internet access
5. provide informed consent to participate.

Exclusion Criteria

1. are pregnant or breastfeeding or expecting to become pregnant during the study follow-up period
2. are deemed unreliable for study procedures or follow-up
3. have a documented allergic reaction to cytisine, or its components (non-medicinal ingredients) or to the non-medicinal ingredients of the placebo.
4. had myocardial infarction, unstable angina, or stroke/transient ischemic attack within the preceding 2 weeks.
5. will have surgery with expected nil intake by mouth for 2 or more days
6. have previously participated in PREVENT
7. have a known diagnosis of untreated pheochromocytoma; Schizophrenia/bipolar psychiatric illness and currently psychotic; currently having suicidal ideation or risk of suicide as determined by the site physician, known history of moderate to severe depression; currently uncontrolled severe hypertension (≥180/120 mmHg) despite treatment; known history of uncontrolled hyperthyroidism (thyrotoxicosis), severe renal impairment i.e., creatinine clearance of less than 30 ml per minute (Cockcroft- Gault equation) or receiving long-term dialysis, or known diagnosis of severe liver disease as determined by the site physician or documented in the clinical history.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cytisine and Video Messaging	Video Messaging	Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support through video messaging.
Placebo and Video Messaging	Video Messaging	Administration of placebo (inactive drug) to patients on a set dose schedule with behavioural support through video messaging.
Cytisine and Video Messaging	Cytisine	Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support through video messaging.
Cytisine and No Video Messaging	Cytisine	Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support according to standard care such as a phone number for a self-help line.

Primary Outcome Measures

Name	Time	Method
Smoking Cessation	6 months	complete abstinence (smoking not more than 5 cigarettes) beginning on day 5 post randomization and lasting until the assessment at 6 months post-randomization with biochemical verification for those who report abstinence, using exhaled breath carbon monoxide (cut-off \<10 parts per million \[ppm\]) measured with a carbon monoxide (CO) monitor

Secondary Outcome Measures

Name	Time	Method
7-day point-prevalence abstinence at 30 days	30 days	Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 30-day follow-up
Time to first lapse	6 months	Time to first cigarette smoked after the initial quit, even a single puff
Death	6 months	The definition of death is all cause mortality.
Urge to smoke	baseline and 6-months	urge to smoke using the Mood and Physical Symptoms Scale \[MPSS\] at baseline and 6 months; a higher score indicates a stronger urge to smoke; To assess the effect of abstinence calculate the change from baseline (just prior to stopping smoking) to the post-abstinence follow-up point for items 1 to 7 and 10 to 12, and take the raw scores for items 8 and 9
Wound complications	6 months	Seroma- wound drainage or repeated dressings required; Wound dehiscence or delayed wound healing
Number of cigarettes smoked daily if still smoking	30 days, 56 days and 6 months	Number of cigarettes smoked daily if still smoking
Infectious complications	6 months	Infection - defined as a pathologic process caused by the invasion of normally sterile tissue, fluid, or body cavity by pathogenic or potentially pathogenic organisms.; Surgical site infection- An infection that occurs within 30 days after surgery and involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional).; Sepsis- Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Sepsis requires a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points due to infection. The qSOFA includes the following items and scoring system: 1. altered mental status (1 point); 2. systolic blood pressure ≤100 mm Hg (1 point); and 3. respiratory rate ≥22 breaths per minute (1 point).
Non-fatal cardiac arrest	6 months	Nonfatal cardiac arrest is defined as successful resuscitation from either documented or presumed ventricular fibrillation, sustained ventricular tachycardia, asystole, or pulseless electrical activity requiring cardiopulmonary resuscitation, pharmacological therapy, or cardiac defibrillation.
Acute hospital care since discharge	after hospital discharge for the study surgery to 6-month follow-up	Acute-hospital care is a composite outcome of hospital re-admission (patient admission to an acute-care hospital) and emergency department visit (patient visit to an emergency department, which includes urgent-care centre visit).
7-day point-prevalence abstinence at 56 days	56-days	Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 56-day follow-up
6 month continuous abstinence rate	6-months	Complete abstinence (smoking not more than 5 cigarettes) beginning on the quit date and lasting until the assessment at 6 months post-randomization with biochemical verification for those who report abstinence, using exhaled breath carbon monoxide (cut-off \<10 ppm) measured with a carbon monoxide (CO) monitor.; \*Cigarettes smoked within 5 days of randomization will be discounted.
Number of Patients with Proximal venous thrombo-embolism	6 months	The diagnosis of PE requires any one of the following: 1. A high probability ventilation/perfusion lung scan,; 2. An intraluminal filling defect of a segmental or larger artery on a helical computerized tomography (CT) scan,; 3. An intraluminal filling defect on pulmonary angiography, or; 4. A positive diagnostic test for deep venous thrombosis A. Non-diagnostic ventilation/perfusion lung scan B. Non-diagnostic helical CT scan.; The diagnosis of proximal DVT (leg or arm) requires: 1. Thrombosis involving the popliteal vein or more proximal veins for leg DVT and axillary or more proximal veins for arm DVT, AND; 2. Evidence of vein thrombosis by any one of the following: 1. A persistent intraluminal filling defect on contrast venography, 2. Non-compressibility of one or more venous segments on B mode compression ultrasonography, or 3. A clearly defined intraluminal filling defect on contrast enhanced computed tomography.
Stroke	6 months	Stroke is defined as either: 1. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting ≥24 hours or leading to death; or 2. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting \<24 hours with positive neuroimaging consistent with a stroke.
7-day point-prevalence abstinence at 6-months	6-months	Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 6-month follow-up
Time to relapse	6 months	Time to return to regular smoking for three or more concurrent days after a period of abstinence.
Respiratory complications	6 months	Pneumonia - defined as an acute infection of the pulmonary parenchyma that is associated with at least one sign or symptom of lower respiratory acute infection (e.g., cough, pleuritic chest pain) or acute systemic illness (e.g., fever, chills, confusion, hypoxemia); accompanied by the presence of an acute infiltrate/consolidation on a chest radiograph or auscultatory findings consistent with pneumonia (such as crackles and/or localized rales) for which there is no other explanation.; Respiratory insufficiency requiring ventilatory support - Patient intubated or put on bilevel positive airway pressure (BiPAP).
Non-fatal Myocardial infarction	6 months	according to the 4th universal definition
Length of hospital stay	time of hospital admission to time of discharge for surgical stay	Defined as time of hospital admission to time of discharge from hospital after index surgery.

Trial Locations

Locations (4)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Kingston Health Science Centre with its research institute Kingston General Health Research Institute; 🇨🇦 Kingston, Ontario, Canada

Lawson Health Research Institute: London Health Sciences Centre Research Inc. and the Lawson Research Institute; 🇨🇦 London, Ontario, Canada