1720 Participants Needed

Cytisine + Video Messaging for Smoking Cessation

(PREVENT Trial)

Recruiting at 3 trial locations
JV
ED
Overseen ByEmily Di Sante
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Population Health Research Institute
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot be using any smoking cessation treatment when you join the study.

What data supports the effectiveness of the treatment Cytisine + Video Messaging for Smoking Cessation?

Research shows that digital and mobile messaging interventions, like text and video messaging, can help people quit smoking by providing real-time support and motivation. Additionally, similar interventions have been found feasible and acceptable, with some studies showing increased quit rates when combined with other therapies.12345

Is the combination of Cytisine and video messaging safe for smoking cessation?

Cytisine has been used for over 40 years in Central and Eastern Europe for smoking cessation and is generally considered safe, with studies showing it is effective and well-tolerated. However, more detailed studies on its safety profile are needed, and there is no specific safety data available for its use with video messaging.678910

How does the drug cytisine differ from other smoking cessation treatments?

Cytisine is unique because it is a low-cost, plant-based drug that acts as a partial agonist on nicotine receptors, helping to reduce nicotine withdrawal symptoms and cravings. Unlike other treatments like nicotine replacement therapy, cytisine has been used for decades in Eastern Europe and offers a natural alternative with a different mechanism of action.7891011

Research Team

SO

Sandra Ofori, Dr.

Principal Investigator

Population Health Research Institute

FK

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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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cytisine or placebo and video messaging or standard care for smoking cessation

6 months
Regular follow-ups at 30 days, 56 days, and 6 months

Follow-up

Participants are monitored for smoking cessation outcomes and complications

6 months
Follow-up assessments at 30 days, 56 days, and 6 months

Treatment Details

Interventions

  • Cytisine
  • Text Messaging
  • Video Messaging
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials
165
Recruited
717,000+

Findings from Research

A fully automated digital smoking cessation intervention, called Happy Ending, significantly improved long-term abstinence rates among participants (22.3%) compared to a control group using a self-help booklet (13.1%) in a study of 396 smokers over 54 weeks.
The treatment group also showed better adherence to nicotine replacement therapy and higher self-efficacy after quitting, suggesting that digital interventions can effectively support behavior change in smoking cessation.
Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention.Brendryen, H., Kraft, P.[2022]
The study involved 119 adult daily cigarette smokers and assessed the feasibility of a mobile chat-based intervention combined with nicotine replacement therapy (NRT-S) for smoking cessation, showing that this approach could increase quit attempts and smoking reduction.
At the 6-month follow-up, participants receiving mobile chat support reported higher rates of quitting (10 vs 3) and smoking reduction (20 vs 11) compared to the control group, indicating that the intervention may enhance the effectiveness of NRT in real-world settings.
Mobile chat-based support plus nicotine replacement therapy sampling to promote smoking cessation for community smokers: A randomized controlled trial.Zhao, SZ., Wu, YS., Chau, SL., et al.[2021]
A text-based Scheduled Gradual Reduction (SGR) program for smoking cessation was found to be feasible and acceptable among rural adults over 60, with 81% of participants reading all messages.
While the SGR group showed a higher biochemically validated cessation rate (15%) compared to the control group (5%), the difference was not statistically significant, indicating potential effectiveness that warrants further investigation.
Feasibility of a text-based smoking cessation intervention in rural older adults.Noonan, D., Silva, S., Njuru, J., et al.[2019]

References

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. [2022]
Mobile chat-based support plus nicotine replacement therapy sampling to promote smoking cessation for community smokers: A randomized controlled trial. [2021]
An open-label pilot study of an intervention using mobile phones to deliver contingency management of tobacco abstinence to high school students. [2019]
Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial. [2019]
Feasibility of a text-based smoking cessation intervention in rural older adults. [2019]
Cytisine for nicotine addiction treatment: a review of pharmacology, therapeutics and an update of clinical trial evidence for smoking cessation. [2020]
Cytisine for smoking cessation: A systematic review and meta-analysis. [2023]
Cytisine Therapy Improved Smoking Cessation in the Randomized Screening and Multiple Intervention on Lung Epidemics Lung Cancer Screening Trial. [2023]
Cytisine for the treatment of nicotine addiction: from a molecule to therapeutic efficacy. [2020]
Study protocol for a non-inferiority trial of cytisine versus nicotine replacement therapy in people motivated to stop smoking. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Placebo-controlled trial of cytisine for smoking cessation. [2016]