Cytisine for Nicotine Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods to help people quit smoking: Cytisine and Nicotine Replacement Therapy (NRT). It aims to support individuals in Ottawa and Toronto who are homeless or at risk of homelessness and actively using tobacco. The trial seeks to improve their quality of life by determining which method is more effective. Those who have used tobacco in the last week and are interested in quitting may be suitable for this trial. Participants must be available for in-person follow-ups for six months.
As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance smoking cessation strategies for vulnerable populations.
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, if you are currently or recently enrolled in another smoking cessation program or using e-cigarettes, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both Nicotine Replacement Therapy (NRT) and cytisine are generally safe options for quitting smoking.
NRT includes products like nicotine patches and gum. Studies indicate that NRT is much safer than smoking and does not cause the same diseases. Some people might experience minor side effects, such as skin irritation from patches or mouth irritation from gum. Serious risks, like nicotine poisoning, rarely occur.
Cytisine, a plant-based treatment, has proven safe in several clinical trials. It works like another quit-smoking drug, varenicline, by helping to reduce the urge to smoke. Side effects are usually mild, such as nausea or sleep problems, and are uncommon.
Both treatments have a strong safety record, but discussing any concerns with a healthcare provider before starting them is important.12345Why are researchers excited about this trial?
Unlike the standard nicotine replacement therapies (NRT) like sprays, patches, gum, lozenges, and inhalers, cytisine offers a unique approach to helping people quit smoking. Cytisine is derived from plant extracts and works by blocking the nicotine receptors in the brain, which helps reduce the craving for nicotine. Researchers are excited about cytisine because it has been used in some European countries with promising results and could be a cost-effective alternative, especially for low-income individuals seeking to quit smoking. Additionally, its plant-based origin and specific receptor-targeting mechanism offer a novel take compared to traditional nicotine-based therapies.
What evidence suggests that this trial's treatments could be effective for improving the quality of life for low-income Canadians who smoke tobacco and other substances?
This trial will compare Nicotine Replacement Therapy (NRT) with Cytisine to help low-income Canadians quit smoking. Studies have shown that NRT reduces cravings and withdrawal symptoms, aiding smoking cessation. Using both nicotine patches and fast-acting options like gum or lozenges can increase success rates. Research also shows that Cytisine is an effective smoking cessation aid. Specifically, about 54% of people using Cytisine remained smoke-free for six months, compared to 31% using NRT. Both treatments effectively support quitting smoking, but Cytisine might offer slightly better long-term success.678910
Who Is on the Research Team?
Smita Pakhale, MD, MSc
Principal Investigator
The Ottawa Hospital, Ottawa Hospital Research Institute
Are You a Good Fit for This Trial?
This trial is for individuals aged 16 or older who live in Ottawa or Toronto, have used multiple substances (excluding marijuana and alcohol) within the past year, and are homeless or at risk of homelessness. It aims to help those with high smoking rates among vulnerable populations.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Cytisine with counseling or Nicotine Replacement Therapy (NRT) with counseling for tobacco dependence
Follow-up
Participants are monitored for safety, effectiveness, and adherence to treatment strategies
Optional Strategy Choice
Participants are given the opportunity to choose either strategy (Cytisine or NRT) at 26 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Improved Quality of Life of low-income Canadians that smoke tobacco and other substances
Trial Overview
The study compares two methods to manage tobacco dependence: Cytisine versus Nicotine Replacement Therapy (NRT). The approach is community-based and peer-led, building on previous success in engaging marginalized groups to reduce drug use.
How Is the Trial Designed?
2
Treatment groups
Active Control
Nicotine Replacement Therapy (NRT): nicotine mouth spray, nicotine patches, nicotine gum, nicotine lozenges, and nicotine oral inhalers
Cytisine: 2x 1.5mg capsules 3 times a day (3mg 3 times a day).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor
Citations
1.
tobaccopreventioncessation.com
tobaccopreventioncessation.com/On-cytisine-s-safety-efficacy-and-cost-effectiveness-in-smoking-cessation-A-brief,194450,0,2.htmlOn cytisine's safety, efficacy and cost-effectiveness in ...
Conclusions: Cytisine is a safe, efficient, cheap, and cost-effective smoking cessation aid as compared with placebo and NRT. Although cytisine ...
An uncontrolled trial of cytisine (Tabex) for smoking cessation
At eight weeks follow‐up, 55% of patients receiving Tabex were reported abstinent compared with 34% on the placebo (p < 0.05). However, abstinence was not ...
3.
icer.org
icer.org/wp-content/uploads/2025/10/ICER_Smoking-Cessation_Draft-Report_For-Publication_102025.pdfCytisinicline for Smoking Cessation: Effectiveness and Value
Other outcomes included point prevalence abstinence throughout 24 weeks, reductions in nicotine and vaping craving, and mood and anxiety.
Comparison of Efficacy and Safety of Cytisine against Nicotine ...
Of the 229 patients treated with cytisine, 124 (54.1%) achieved 6-month abstinence, compared to 77 of 247 patients (31.2%) in the NRT group (p<.
Cytisine for smoking cessation: A systematic review and ...
Pooled analysis of seven studies demonstrated that cytisine significantly increased biochemically-verified continuous abstinence at 24 weeks or ...
Public Health Impact of FDA's Request for Additional Safety ...
We found that cytisine would still have an important impact on health outcomes even with lower relative effectiveness. Cytisine uptake may also ...
DESMOXAN
The analeptic effect of cytisine decreases during combined therapy with anti-tuberculosis drugs (PASA and streptomycin). No clinical data pertaining to ...
Public Health Impact of FDA's Request for Additional Safety ...
Cytisine, a plant-based partial agonist of nicotinic acetylcholine receptors, has demonstrated safety and efficacy in several randomized clinical trials and is ...
Cytisine
Cytisine is a safe and effective treatment. It works in a similar way to varenicline (Champix), reducing urges to smoke by attaching to some of the same ...
How Safe Is Desmoxan and Its Key Ingredient Cytisine?
This in-depth article reviews the clinical safety data, reported side effects, contraindications, and comparative risk assessment of Desmoxan ...
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