PeRiopEratiVE SmokiNg CessaTion Trial

NCT05102123 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 2022_09_01
• Study Type: interventional
• Target: 1,720
• Locations: 1 country
• Sites: 4

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.

Conditions

Smoking (Tobacco) Addiction; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Smoking Cessation

  complete abstinence (smoking not more than 5 cigarettes) beginning on day 5 post randomization and lasting until the assessment at 6 months post-randomization with biochemical verification for those who report abstinence, using exhaled breath carbon monoxide (cut-off \<10 parts per million \[ppm\]) measured with a carbon monoxide (CO) monitor

  6 months

Secondary Outcomes (18)

• 7-day point-prevalence abstinence at 30 days

  30 days

• 7-day point-prevalence abstinence at 56 days

  56-days

• 7-day point-prevalence abstinence at 6-months

  6-months

• Urge to smoke

  baseline and 6-months

• Number of cigarettes smoked daily if still smoking

  30 days, 56 days and 6 months

Other Outcomes (2)

• Health services utilization-related costs

  6-months

• Health-related quality of life (HRQoL)

  baseline and 6-months

Study Arms (4)

Cytisine and Video Messaging

EXPERIMENTAL

Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support through video messaging.

Drug: Cytisine; Behavioral: Video Messaging

Placebo and Video Messaging

PLACEBO COMPARATOR

Administration of placebo (inactive drug) to patients on a set dose schedule with behavioural support through video messaging.

Behavioral: Video Messaging

Cytisine and No Video Messaging

ACTIVE COMPARATOR

Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support according to standard care such as a phone number for a self-help line.

Drug: Cytisine

Placebo and No Video Messaging

NO INTERVENTION

Administration of placebo (inactive drug) to patients on a set dose schedule behavioural support according to standard care such as a phone number for a self-help line.

Interventions

Cytisine DRUG

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

Cytisine and No Video Messaging; Cytisine and Video Messaging

Video Messaging BEHAVIORAL

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

Cytisine and Video Messaging; Placebo and Video Messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are ≥18 years of age
• are scheduled to undergo surgery within 28 days
• are a current smoker and not currently using any smoking cessation treatment and,
• have a smart mobile phone with an active, up to date data plan and with internet access
• provide informed consent to participate.

You may not qualify if:

• are pregnant or breastfeeding or expecting to become pregnant during the study follow-up period
• are deemed unreliable for study procedures or follow-up
• have a documented allergic reaction to cytisine, or its components (non-medicinal ingredients) or to the non-medicinal ingredients of the placebo.
• had myocardial infarction, unstable angina, or stroke/transient ischemic attack within the preceding 2 weeks.
• will have surgery with expected nil intake by mouth for 2 or more days
• have previously participated in PREVENT
• 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.

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (4)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Science Centre with its research institute Kingston General Health Research Institute

Kingston, Ontario, K7L 3N6, Canada

Location

Lawson Health Research Institute: London Health Sciences Centre Research Inc. and the Lawson Research Institute

London, Ontario, N6C 2R5, Canada

Location

MeSH Terms

Conditions

Smoking; Behavior, Addictive; Smoking Cessation

Interventions

cytisine

Condition Hierarchy (Ancestors)

Behavior; Compulsive Behavior; Impulsive Behavior; Health Behavior

Study Officials

• Sandra Ofori, Dr.

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Flavia Kessler Borges, Dr.

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 factorial

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: January 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)