Cytisine + Video Messaging for Smoking Cessation

(PREVENT Trial)

Not currently recruiting at 3 trial locations

Overseen By Emily Di Sante

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Population Health Research Institute

Disqualifiers: Pregnancy, Schizophrenia, Bipolar, Severe hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 60

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether cytisine, a medication, and video messaging can help people quit smoking after surgery. It compares cytisine to a placebo (an inactive substance) and tests if video messaging provides more support than standard care. Current smokers planning to have surgery soon and possessing a smartphone with internet access might be suitable for this trial. The goal is to determine if these methods can help people remain smoke-free for six months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cytisine is a safe and effective aid for quitting smoking. Studies have found it more effective than both a placebo and nicotine replacement therapy (NRT) in helping people stop smoking. Cytisine is generally well-tolerated, but like many medicines, it can be harmful in large amounts. However, the doses used for smoking cessation are safe. No major reports of serious side effects have occurred at these recommended doses. This makes cytisine a promising option for those wanting to quit smoking, with a safety record supported by research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Cytisine is unique because it targets nicotine receptors to help reduce cravings and withdrawal symptoms, offering a natural plant-based alternative to traditional smoking cessation aids like nicotine replacement therapies and medications such as varenicline and bupropion. Researchers are excited about cytisine because it has shown promise in helping people quit smoking with potentially fewer side effects, thanks to its plant-derived origins. Additionally, using video messaging as part of the treatment approach provides behavioral support in a modern, accessible way, which might enhance the overall effectiveness of the smoking cessation process.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research shows that cytisine, one of the treatments in this trial, can help people quit smoking. Studies have found that it more than doubles the chances of quitting compared to a placebo, which contains no active ingredients. In this trial, some participants will receive cytisine with video messaging support, while others will receive cytisine without it. Cytisine has also proven more effective than nicotine patches or gums in helping people remain smoke-free long-term. Most people tolerate it well, experiencing no serious side effects. While more information is needed about its effects beyond six months, current results are encouraging for those wanting to quit smoking. ^{3 6 7 8 9}

Who Is on the Research Team?

Flavia Kessler Borges, Dr.

Principal Investigator

Population Health Research Institute

Sandra Ofori, Dr.

Principal Investigator

Population Health Research Institute

Are You a Good Fit for This Trial?

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 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.

You have agreed to provide informed consent for participation.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cytisine
• Text Messaging
• Video Messaging

Trial Overview 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.

How Is the Trial Designed?

Group I: Cytisine and Video Messaging Experimental Treatment 2 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 Messaging Active Control 1 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 Messaging Active Control 1 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 Messaging Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

Published Research Related to This Trial

Cytisine has been shown to significantly improve smoking cessation rates compared to placebo, with a recent trial of 740 participants reporting 12-month continuous abstinence rates of 8.4% for cytisine versus 2.4% for placebo, indicating a relative risk of 3.4.

A new trial involving 1,310 participants aims to determine if cytisine is at least as effective as nicotine replacement therapy (NRT) for helping smokers quit, which could position cytisine as a low-cost and acceptable alternative for smoking cessation, especially in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a non-inferiority trial of cytisine versus nicotine replacement therapy in people motivated to stop smoking. Walker, N., Howe, C., Bullen, C., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a text-based smoking cessation intervention in rural older adults. Noonan, D., Silva, S., Njuru, J., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. Brendryen, H., Kraft, P.[2022]

In a randomized controlled trial involving 869 heavy smokers, cytisine combined with counseling led to a significant quit rate of 32.1% at 12 months, compared to only 7.3% in the counseling-only group, demonstrating its efficacy as a smoking cessation aid.

While cytisine was effective, it was associated with a higher frequency of self-reported adverse events, particularly gastrointestinal issues, indicating that while it is a promising treatment, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytisine Therapy Improved Smoking Cessation in the Randomized Screening and Multiple Intervention on Lung Epidemics Lung Cancer Screening Trial. Pastorino, U., Ladisa, V., Trussardo, S., et al.[2023]

Cytisine, a smoking cessation medication used since 1964, has shown a significant increase in the likelihood of successful continuous abstinence from smoking, with a relative risk of 1.74 compared to placebo based on a meta-analysis of eight studies.

The most common adverse reactions associated with cytisine are mild to moderate gastrointestinal symptoms, such as nausea and vomiting, making it a relatively safe option for those looking to quit smoking, especially considering its low cost compared to other cessation medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytisine for nicotine addiction treatment: a review of pharmacology, therapeutics and an update of clinical trial evidence for smoking cessation. Tutka, P., Vinnikov, D., Courtney, RJ., et al.[2020]

Cytisine significantly improved smoking cessation rates, with 8.4% of participants achieving sustained abstinence after 12 months compared to only 2.4% in the placebo group, based on a study involving 740 adult smokers.

While cytisine was effective, it was associated with a higher incidence of gastrointestinal side effects, indicating that while it is a promising low-cost treatment for smoking cessation, monitoring for adverse effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-controlled trial of cytisine for smoking cessation. West, R., Zatonski, W., Cedzynska, M., et al.[2016]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa1407764

Cytisine versus Nicotine for Smoking Cessation The effectiveness of cytisine for continuous abstinence was superior to that of nicotine-replacement therapy at 1 week, 2 months, and 6 months.

2. medrxiv.org medrxiv.org/content/10.1101/2025.07.23.25332030v1.full-text

Cytisine for smoking cessation: A systematic review and ... Insufficient data on long-term outcomes: Most studies reported outcomes at 24-26 weeks; longer-term effectiveness remains uncertain. Research ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38161271/

Evaluation of the effectiveness of cytisine for the treatment ... Conclusions: Cytisine increases the chances of successful smoking cessation by more than twofold compared with placebo and has a benign safety profile, with no ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2832701

Cytisinicline for Smoking Cessation: The ORCA Phase 3 ... Cytisinicline reduced nicotine cravings and was well tolerated. Meaning These results demonstrate the high smoking cessation efficacy and ...

5. tobaccopreventioncessation.com tobaccopreventioncessation.com/On-cytisine-s-safety-efficacy-and-cost-effectiveness-in-smoking-cessation-A-brief,194450,0,2.html

On cytisine's safety, efficacy and cost-effectiveness in ... For the primary outcome and longer abstinence, cytisine is more efficient than placebo and NRT but has less efficacy than varenicline.

6. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2822687

Public Health Impact of FDA's Request for Additional Safety ... Findings In a mathematical model, making cytisine available immediately could lead approximately 71 000 more people to quit smoking over 1 year ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11344233/

Public Health Impact of FDA's Request for Additional Safety ... In a mathematical model, making cytisine available immediately could lead approximately 71 000 more people to quit smoking over 1 year and ...

8. ncsct.co.uk ncsct.co.uk/library/view/pdf/Cytisine.pdf

Cytisine Like many medicines, Cytisine is poisonous in high doses but safe at the doses used in the stop smoking medicines. Page 22. Clinical issues. Q6. Does the quit ...

9. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1350176/full

Safety and efficacy of CyTisine for smoking cessation in a ... The current protocol describes a prospective observational study on the safety and efficacy of CYT administered to inpatient smokers.