Clinical trial NCT05102123: PeRiopEratiVE SmokiNg CessaTion Trial
Official title: PeRiopEratiVE SmokiNg CessaTion Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Smoking (Tobacco) Addiction
Smoking Cessation
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 1720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Smoking Cessation
timeFrame: 6 months
Secondary outcomes:
measure: 7-day point-prevalence abstinence at 30 days
timeFrame: 30 days
measure: 7-day point-prevalence abstinence at 56 days
timeFrame: 56-days
measure: 7-day point-prevalence abstinence at 6-months
timeFrame: 6-months
measure: Urge to smoke
timeFrame: baseline and 6-months
measure: Number of cigarettes smoked daily if still smoking
timeFrame: 30 days, 56 days and 6 months
measure: Time to first lapse
timeFrame: 6 months
measure: Time to relapse
timeFrame: 6 months
measure: 6 month continuous abstinence rate
timeFrame: 6-months
measure: Wound complications
timeFrame: 6 months
measure: Infectious complications
timeFrame: 6 months
measure: Respiratory complications
timeFrame: 6 months
measure: Non-fatal Myocardial infarction
timeFrame: 6 months
measure: Number of Patients with Proximal venous thrombo-embolism
timeFrame: 6 months
measure: Stroke
timeFrame: 6 months
measure: Non-fatal cardiac arrest
timeFrame: 6 months
measure: Death
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: time of hospital admission to time of discharge for surgical stay
measure: Acute hospital care since discharge
timeFrame: after hospital discharge for the study surgery to 6-month follow-up
Other outcomes:
measure: Health services utilization-related costs
timeFrame: 6-months
measure: Health-related quality of life (HRQoL)
timeFrame: baseline and 6-months
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Science Centre with its research institute Kingston General Health Research Institute
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute: London Health Sciences Centre Research Inc. and the Lawson Research Institute
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Sandra Ofori, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Flavia Kessler Borges, Dr.
role: PRINCIPAL_INVESTIGATOR
References: