Phase IV, randomized, open-label, open-label, controlled, parallel, multicenter clinical trial in patients who are candidates for smoking cessation to evaluate the safety and efficacy of citisinicline maintenance therapy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

23 Jan 2026 → ongoing

Decision date (initial)

2025-05-05

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacoeconomic

The general objective of this study is to evaluate the efficacy, safety and economic impact of two prolonged regimens of cytisinicline (50 and 75 days in duration) and Compare them with the usual regimen (25 days).

Secondary objectives 25

1. Determine the abstinence rate maintained in each of the three regimens studied, at 6 and 12 months according to the results obtained in the cotinine tests.
2. Determine the correlation between the abstinence rate maintained in each of the three regimens studied, at 6 and 12 months according to the results obtained in the cotinine tests in comparison to the abstinence declared at 6 and 12 months.
3. Determine the punctual abstinence rate, assessed every 7 days, at home one of the three guidelines studied according to the results obtained in the cotinine tests, as well as the prevalence of probabilities and the 95% CI.
4. Analyze and compare the percentage increase in abstinence rates with the increase in time of use of cytisinicline.
5. Calculate the necessary number of patients who need to be treated for one of them to stop smoking in each of the treatment arms.
6. Analyze and compare abstinence maintained from day 25 to day 50 in the 3 study arms.
7. Analyze and compare abstinence maintained from day 25 to day 75 in the 3 study arms.
8. Analyze and compare abstinence maintained from day 25 to 6 and 12 months in the 3 study arms.
9. To analyze and compare the frequency and percentage of relapses in those who quit smoking from day 25 to 6 and 12 months in the 3 arms.
10. To analyze the mean value of the Minnesota test (MNWS) in the initial in-person visit in the 3 arms and its variation with respect to said visit on day 25, day 50 and day 75 in the 3 arms under study.
11. To analyze clinical, anthropometric, demographic and smoking-associated variables that predict sustained abstinence at 6 and 12 months in the 3 study groups.
12. To analyze clinical, anthropometric, demographic and smoking-associated variables that predict relapses in the 3 study arms.
13. Analyze pharmacokinetic variables that predict sustained abstinence in the 3 intervention arms.
14. Determine blood drug levels and look for biomarkers that may be related to drug effectiveness.
15. Study the impact of morbidity and mortality in each arm.
16. Determine the percentage of side effects reported by participants and compare their prevalence in each arm during the study process (1 year).
17. Determine the percentage of adverse effects at 25 days, 50 days and 75 days in the participants and compare their prevalence in each of the arms.
18. Compare the prevalence and severity of side effects of each regimen during the study process (1 year).
19. Compare the results of the cardiac, hepatic and renal variables between each arm, as safety indicators of the treatments in each arm during the study process (1 year).
20. Compare the results of cardiac, hepatic and renal variables in each arm. As safety indicators of the treatments in each arm at 25 days, 50 days and 75 days of treatment.
21. To evaluate the cost-effectiveness and cost-utility relationship of two prolonged regimens of cytisinicline and compare them with the usual regimen.
22. To evaluate the effect that adherence to treatment has on the cost-effectiveness and cost-utility relationship of the therapeutic alternatives considered.
23. To evaluate the effect of clinical, anthropometric and demographic variables that predict sustained abstinence at 6 and 12 months on the cost-effectiveness and cost-utility relationship in the 3 study groups.
24. Carry out a simulation of the future effects, 15, 30 and 50 years after quitting smoking.
25. Design a budget impact model to evaluate in financial terms the possible savings for the National Health System.

Conditions and MedDRA coding

Active smokers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Men and women of legal age who smoke more than 10 cigarettes a day during the last year and during the last month of the screening visit.
2. Be prepared and motivated to quit smoking (have a score on the visual analog motivation scale greater than or equal to 7).
3. Not having been on pharmacological treatment for nicotine dependence (nicotine replacement therapy [NRT], varenicline, bupropion or cytisinicline) during the last 3 months.

Exclusion criteria 13

1. Kidney and/or liver failure.
2. Over 65 years of age (due to limited clinical experience).
3. Hypersensitivity to the active ingredient or to any of the excipients.
4. Unstable angina.
5. Recent personal history of acute myocardial infarction or recent stroke (less than 8 weeks).
6. Arrhythmias with clinical relevance or uncontrolled arterial hypertension.
7. History of psychiatric illness with and without treatment (panic disorder, psychosis, bipolar disorder, depression) in the last 12 months.
8. History of alcohol or other drug abuse in the last 12 months.
9. Use of tobacco products other than cigarettes, e-cigarettes, or marijuana in the past month and did not agree to abstain from using these products during study participation.
10. Patients receiving treatment with antituberculosis drugs.
11. Patients receiving drugs metabolized by the CYP1A2 and CYP1A1 enzyme, especially those with a narrow therapeutic range (e.g., theophylline, tacrine, clozapine, and ropinirole).
12. Women treated with systemic hormonal contraceptives.
13. Pregnant or breastfeeding women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. It will be carried out by evaluating punctual and continuous abstinence at 3, 6 and 12 months.
2. The safety results will be carried out by evaluating the incidence of the side effects foreseen in the technical data sheet.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela

Sponsor organisation

Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela

Address

Travesia Da Choupana S/N

City

Santiago De Compostela

Postcode

15706

Country

Spain

Scientific contact point

Organisation

Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela

Contact name

Carlos Rábade Castedo

Public contact point

Organisation

Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela

Contact name

Carlos Rábade Castedo

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications