PeRiopEratiVE SmokiNg CessaTion Trial

Phase 3Active Not RecruitingNCT05102123

Population Health Research Institute1,720 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,720

Conditions

Smoking (Tobacco) Addiction Smoking Cessation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Smoking Cessation

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

Time frame: 6 months

Secondary Outcomes

7-day point-prevalence abstinence at 30 days

Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 30-day follow-up

Time frame: 30 days

7-day point-prevalence abstinence at 56 days

Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 56-day follow-up

Time frame: 56-days

7-day point-prevalence abstinence at 6-months

Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 6-month follow-up

Time frame: 6-months

Urge to smoke

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

Time frame: baseline and 6-months

Number of cigarettes smoked daily if still smoking

Time frame: 30 days, 56 days and 6 months

Time to first lapse

Time to first cigarette smoked after the initial quit, even a single puff

Time frame: 6 months

Time to relapse

Time to return to regular smoking for three or more concurrent days after a period of abstinence.

Time frame: 6 months

6 month continuous abstinence rate

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.

Time frame: 6-months

Wound complications

Seroma- wound drainage or repeated dressings required; Wound dehiscence or delayed wound healing

Time frame: 6 months

Infectious complications

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).

Time frame: 6 months

Respiratory complications

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).

Time frame: 6 months

Non-fatal Myocardial infarction

according to the 4th universal definition

Time frame: 6 months

Number of Patients with Proximal venous thrombo-embolism

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.

Time frame: 6 months

Stroke

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.

Time frame: 6 months

Non-fatal cardiac arrest

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.

Time frame: 6 months

Death

The definition of death is all cause mortality.

Time frame: 6 months

Length of hospital stay

Defined as time of hospital admission to time of discharge from hospital after index surgery.

Time frame: time of hospital admission to time of discharge for surgical stay

Acute hospital care since discharge

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).

Time frame: after hospital discharge for the study surgery to 6-month follow-up