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Nicotinic Acetylcholine Receptor Agonist

Cytisine and Video Messaging for Smoking Addiction (PREVENT Trial)

Phase 3

Recruiting

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

PREVENT 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.Check my eligibility

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.See study design

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.

PREVENT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

PREVENT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Smoking Cessation

Secondary outcome measures

6 month continuous abstinence rate

7-day point-prevalence abstinence at 30 days

7-day point-prevalence abstinence at 56 days

+15 more

Other outcome measures

Health services utilization-related costs

Health-related quality of life (HRQoL)

PREVENT 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 3

~1710

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

678,192 Total Patients Enrolled

Flavia Kessler Borges, Dr.Principal InvestigatorPopulation Health Research Institute

Sandra Ofori, Dr.Principal InvestigatorPopulation Health Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this medical study?

"Indeed, as per the information available on clinicaltrials.gov, this trial is currently seeking eligible participants. The initial posting of the study occurred on January 15th, 2024 and it was most recently updated on January 17th, 2024. The research aims to enroll a total of 1720 patients from two distinct locations."

Answered by AI

Are there any potential risks associated with the utilization of Cytisine and Video Messaging for individuals?

"Based on our evaluation, the safety of Cytisine and Video Messaging is assigned a score of 3 due to it being a Phase 3 trial. This indicates that there is existing evidence supporting its effectiveness along with multiple rounds of data demonstrating its safety."

Answered by AI

Are patients currently able to participate in this ongoing trial?

"Indeed, the data available on clinicaltrials.gov clearly states that this particular trial is currently in the active recruitment phase. The initial posting of the trial occurred on January 15th, 2024, and it was last edited on January 17th, 2024. For this study, a total of 1720 participants are being sought across two designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PeRiopEratiVE smokiNg cessaTion Trial

2024. "PeRiopEratiVE smokiNg cessaTion Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05102123.

All > Smoking Cessation