PeRiopEratiVE smokiNg cessaTion Trial

2022_09_01

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.

2024-01-15

2026-07-01

2027-01-01

Recruiting

Early phase I

1720

Inclusion Criteria: 1. are ≥18 years of age 2. are scheduled to undergo surgery within 1-28 days 3. are a current smoker (i.e., smoked at least 10 cigarettes per day during the previous year and had no period of smoking abstinence longer than 6 months) 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.

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2024-04-16