PeRiopEratiVE smokiNg cessaTion Trial

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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 text 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute

Criteria

Inclusion Criteria:

• are ≥18 years of age

• are scheduled to undergo surgery within 28 days or are hospitalized for surgery

• are a current smoker (>100 cigarettes lifetime consumption and self-report of smoking every day or most days in the last 30 days) and not currently using any smoking cessation treatment and,

• provide informed consent to participate.

Exclusion Criteria:

• are deemed unreliable for study procedures or follow-up

• are pregnant or breastfeeding or expecting to become pregnant during the study follow-up period

• have a documented allergic reaction to cytisine

• had myocardial infarction, severe angina or stroke/transient ischemic attack within the preceding 2 weeks.