PeRiopEratiVE SmokiNg CessaTion Trial (PREVENT)

Population Health Research Institute (PHRI)

Status and phase: Active, not recruiting; Phase 3

Conditions: Smoking (Tobacco) Addiction; Smoking Cessation

Treatments: Drug: Cytisine; Behavioral: Video Messaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05102123

2022_09_01

Details and patient eligibility

About

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.

Enrollment: 1,720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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1,720 participants in 4 patient groups, including a placebo group

Cytisine and Video Messaging

Experimental group

Description:

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

Treatment:

Behavioral: Video Messaging

Drug: Cytisine

Placebo and Video Messaging

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Video Messaging

Cytisine and No Video Messaging

Active Comparator group

Description:

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.

Treatment:

Drug: Cytisine

Placebo and No Video Messaging

No Intervention group

Description:

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.