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Nicotinic Acetylcholine Receptor Agonist

Cytisine + Video Messaging for Smoking Cessation (PREVENT Trial)

Phase 3

Waitlist Available

Led By Flavia Kessler Borges, Dr.

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

are ≥18 years of age

are a current smoker (i.e., smoked at least 10 cigarettes per day during the previous year and had no period of smoking abstinence longer than 6 months) and not currently using any smoking cessation treatment and

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

Summary

This trial, called PREVENT, is studying the effects of cytisine versus a placebo, as well as the effects of video messaging versus standard care, on people who are about to have surgery.

Who is the study for?

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.

What is being tested?

This 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.

What are the potential side effects?

Cytisine may cause mild side effects like nausea, headache, dry mouth, and trouble sleeping. Video messaging has no physical side effects but could affect privacy or lead to increased screen time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Smoking Cessation

Secondary study objectives

6 month continuous abstinence rate

7-day point-prevalence abstinence at 30 days

7-day point-prevalence abstinence at 56 days

+15 more

Other study objectives

Health services utilization-related costs

Health-related quality of life (HRQoL)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytisine

2017

Completed Phase 4

~3830

0 / 2Eligibility criteria met