Cytisine + Video Messaging for Smoking Cessation
(PREVENT Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byFlavia Kessler Borges, Dr.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Population Health Research Institute

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sandra Ofori, Dr.

Principal Investigator

Population Health Research Institute

Flavia Kessler Borges, Dr.

Principal Investigator

Population Health Research Institute

Eligibility Criteria

The PREVENT trial is for adults over 18 who smoke at least 10 cigarettes daily, haven't quit for more than 6 months in the past year, and are scheduled for surgery within the next 1-28 days. Participants must not be on smoking cessation treatments but should have a smartphone with an active data plan.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for surgery within the next 28 days.

I currently smoke at least 10 cigarettes daily and haven't tried to quit for more than 6 months.

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Treatment Details

Interventions

Cytisine (Nicotinic Acetylcholine Receptor Agonist)
Text Messaging (Behavioral Intervention)
Video Messaging (Behavioral Intervention)

Trial OverviewThis study tests if cytisine (a plant-based compound) helps people quit smoking better than a placebo. It also checks if video messages can boost quitting success compared to usual care. Patients will be randomly assigned to receive either cytisine or placebo, and video messaging support or standard care.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Cytisine and Video MessagingExperimental Treatment2 Interventions

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

Group II: Cytisine and No Video MessagingActive Control1 Intervention

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 III: Placebo and No Video MessagingActive Control1 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.

Group IV: Placebo and Video MessagingPlacebo Group1 Intervention

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