Study Results
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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ACTIVE_NOT_RECRUITING
PHASE3
1720 participants
INTERVENTIONAL
2024-01-15
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
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.
Cytisine
Listed as a natural health product in Canada, cytisine is utilized to aid in smoking cessation
Video Messaging
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.
Video Messaging
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.
Cytisine
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.
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
Video Messaging
Supportive messaging utilizing a video messaging platform to encourage patients to abstain from smoking throughout the treatment period.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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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
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Kingston Health Science Centre with its research institute Kingston General Health Research Institute
Kingston, Ontario, Canada
Lawson Health Research Institute: London Health Sciences Centre Research Inc. and the Lawson Research Institute
London, Ontario, Canada
Countries
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Other Identifiers
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2022_09_01
Identifier Type: -
Identifier Source: org_study_id
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