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PeRiopEratiVE SmokiNg CessaTion Trial

Study acronym: PREVENT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 3, 2024 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 4 of 4 sitesv10 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
  2. Study sites: 3 to 4v9
  3. Study sites: 2 to 3 Eligibility criteria shortened, about 23 words · Secondary endpoints revised (18)v8 Show 2 more changesShow less
    • Eligibility criteria shortened, about 23 words
    • Secondary endpoints revised (18)

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv7
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Primary completion date: Jun 1, 2026 to Jul 1, 2026 · Completion date: Dec 1, 2026 to Jan 1, 2027 · 1 morev6 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Jun 1, 2026 to Jul 1, 2026
    • Completion date: Dec 1, 2026 to Jan 1, 2027
    • Start date changed from estimate of Dec 1, 2023 to Jan 15, 2024
Show 4 earlier versionsHide 4 earlier versions
  1. Phase: Phase 2/3 to Phase 3 Start date: Sep 1, 2023 to Dec 1, 2023 · Primary completion date: Mar 1, 2026 to Jun 1, 2026 · Completion date: Sep 1, 2026 to Dec 1, 2026 · 2 morev5 Show 5 more changesShow less
    • Start date: Sep 1, 2023 to Dec 1, 2023
    • Primary completion date: Mar 1, 2026 to Jun 1, 2026
    • Completion date: Sep 1, 2026 to Dec 1, 2026
    • Eligibility criteria expanded, about 103 words
    • Secondary endpoints revised (18)

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Apr 1, 2023 to Sep 1, 2023 Primary completion date: Oct 1, 2025 to Mar 1, 2026 · Completion date: Apr 1, 2026 to Sep 1, 2026 · Interventions: Cytisine (Drug), Text Messaging (Behavioral) to Cytisine (Drug), Video Messaging (Behavioral) · 2 morev4 Show 5 more changesShow less
    • Primary completion date: Oct 1, 2025 to Mar 1, 2026
    • Completion date: Apr 1, 2026 to Sep 1, 2026
    • Interventions: Cytisine (Drug), Text Messaging (Behavioral) to Cytisine (Drug), Video Messaging (Behavioral)
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: 12 to 18

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Mar 1, 2025 to Oct 1, 2025 Start date: Sep 1, 2022 to Apr 1, 2023 · Completion date: Sep 1, 2025 to Apr 1, 2026v3 Show 2 more changesShow less
    • Start date: Sep 1, 2022 to Apr 1, 2023
    • Completion date: Sep 1, 2025 to Apr 1, 2026
  4. Start date: Apr 1, 2022 to Sep 1, 2022 Primary completion date: Oct 1, 2024 to Mar 1, 2025 · Completion date: Apr 1, 2025 to Sep 1, 2025v2 Show 2 more changesShow less
    • Primary completion date: Oct 1, 2024 to Mar 1, 2025
    • Completion date: Apr 1, 2025 to Sep 1, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05102123
Lead Sponsor Population Health Research Institute
Conditions Smoking (Tobacco) Addiction, Smoking Cessation
Enrollment 1,720 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov