PeRiopEratiVE SmokiNg CessaTion Trial

NCT ID: NCT05102123

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking (Tobacco) Addiction Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 factorial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cytisine and Video Messaging

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

Group Type EXPERIMENTAL

Cytisine

Intervention Type DRUG

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

Video Messaging

Intervention Type BEHAVIORAL

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

Placebo and Video Messaging

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

Group Type PLACEBO_COMPARATOR

Video Messaging

Intervention Type BEHAVIORAL

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

Cytisine and No Video Messaging

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.

Group Type ACTIVE_COMPARATOR

Cytisine

Intervention Type DRUG

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

Placebo and No Video Messaging

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cytisine

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

Intervention Type DRUG

Video Messaging

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Ofori, Dr.

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Flavia Kessler Borges, Dr.

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

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Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

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

Kingston, Ontario, Canada

Site Status

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

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2022_09_01

Identifier Type: -

Identifier Source: org_study_id

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