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PeRiopEratiVE SmokiNg CessaTion Trial

NCT05102123 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1720

Last updated 2024-10-03

No results posted yet for this study

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.

Conditions

  • Smoking (Tobacco) Addiction
  • Smoking Cessation

Interventions

DRUG

Cytisine

Listed as a natural health product in Canada, cytisine is utilized to aid in smoking cessation

BEHAVIORAL

Video Messaging

Supportive messaging utilizing a video messaging platform to encourage patients to abstain from smoking throughout the treatment period.

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Sandra Ofori, Dr. · Population Health Research Institute

  • Flavia Kessler Borges, Dr. · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2026-07-01
Completion
2027-01-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05102123 on ClinicalTrials.gov