Clinical trial • Phase IV • Respiratory

Cytisinicline for Nicotine dependence

Phase IV trial of Cytisinicline for Nicotine dependence.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Nicotine dependence
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-01-2025
First CTIS Authorization Date
05-05-2025

Trial design

Randomised, open-label, comparator arms: usual regimen (25 days) of cytisinicline compared with two prolonged regimens of cytisinicline of 50 days and 75 days. (cytisinicline investigational product: recigarum 1.5 mg film-coated tablets).-controlled Phase IV trial in Spain.

Randomised
Yes
Open Label
Yes
Comparator
Comparator arms: usual regimen (25 days) of cytisinicline compared with two prolonged regimens of cytisinicline of 50 days and 75 days. (Cytisinicline investigational product: Recigarum 1.5 mg film-coated tablets).
Target Sample Size
400
Trial Duration For Participant
365

Eligibility

Recruits 400 Vulnerable population is selected in the trial metadata. The inclusion criteria specify participants are "Men and women of legal age"; no further details on consent/assent handling for vulnerable groups are provided in the available metadata/documents..

Pregnancy Exclusion
Pregnant or breastfeeding women.
Vulnerable Population
Vulnerable population is selected in the trial metadata. The inclusion criteria specify participants are "Men and women of legal age"; no further details on consent/assent handling for vulnerable groups are provided in the available metadata/documents.

Inclusion criteria

  • {"criterion_text":"- 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.\n- Be prepared and motivated to quit smoking (have a score on the visual analog motivation scale greater than or equal to 7).\n- Not having been on pharmacological treatment for nicotine dependence (nicotine replacement therapy [NRT], varenicline, bupropion or cytisinicline) during the last 3 months."}

Exclusion criteria

  • {"criterion_text":"- Kidney and/or liver failure.\n- Patients receiving treatment with antituberculosis drugs.\n- Patients receiving drugs metabolized by the CYP1A2 and CYP1A1 enzyme, especially those with a narrow therapeutic range (e.g., theophylline, tacrine, clozapine, and ropinirole).\n- Women treated with systemic hormonal contraceptives.\n- Pregnant or breastfeeding women.\n- Over 65 years of age (due to limited clinical experience).\n- Hypersensitivity to the active ingredient or to any of the excipients.\n- Unstable angina.\n- Recent personal history of acute myocardial infarction or recent stroke (less than 8 weeks).\n- Arrhythmias with clinical relevance or uncontrolled arterial hypertension.\n- History of psychiatric illness with and without treatment (panic disorder, psychosis, bipolar disorder, depression) in the last 12 months.\n- History of alcohol or other drug abuse in the last 12 months.\n- 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."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- It will be carried out by evaluating punctual and continuous abstinence at 3, 6 and 12 months.","definition_or_measurement_approach":"Evaluation of punctual and continuous abstinence at 3, 6 and 12 months (time points specified)."}
  • {"endpoint_text":"- The safety results will be carried out by evaluating the incidence of the side effects foreseen in the technical data sheet.","definition_or_measurement_approach":"Assessment of incidence of side effects as listed in the product technical data sheet (SmPC)."}

Recruitment

Planned Sample Size
400
Recruitment Window Months
36
Consent Approach
Informed consent is to be obtained from participants (men and women of legal age). Subject information and informed consent form documents are listed in the trial documents ('Hoja informacion paciente - CI_for pub' and 'Hoja de informacion al paciente y consentimiento informado _con cambios _ for pub'). No further details on assent, age-specific documents or languages are provided in the available metadata.

Geography

Total Number Of Sites
10
Total Number Of Participants
400

Spain

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
21-08-2025
Processing Time Days
129
Number Of Sites
10
Number Of Participants
400

Sites

Site Name
Hospital Universitario De Caceres
Department Name
Neumología
Contact Person Name
Juan Antonio Riesco Miranda
Contact Person Email
jantonio.riesco@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Neumología
Contact Person Name
Carlos Rábade Castedo
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neumología
Contact Person Name
Agustín Salvador Valido Morales
Contact Person Email
asvmtino@gmail.com
Site Name
Hospital De Galdakao Usansolo
Department Name
Neumología
Contact Person Name
María Inmaculada Gorordo Unzueta
Site Name
Hospital Clinic De Barcelona
Department Name
Neumología
Contact Person Name
Jacobo Sellarés Torres
Contact Person Email
sellares@clinic.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neumología
Contact Person Name
José Ignacio de Granda Orive
Contact Person Email
igo01m@gmail.com
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Neumología
Contact Person Name
Ángela Ramos Pinedo
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Neumología
Contact Person Name
Jaime Signes-Costa Miñana
Contact Person Email
jaimesignescosta@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Neumología
Contact Person Name
José Luis Velasco Garrido
Contact Person Email
estudios.clinicos@ibima.eu
Site Name
Hospital Clinico San Carlos
Department Name
Neumología
Contact Person Name
María Isabel Cristóbal Fernández
Contact Person Email
maribel.cristobal@hotmail.com

Sponsor

Primary sponsor

Full Name
Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Recigarum 1,5 mg comprimidos recubiertos con película EFG
Active Substance
Cytisinicline
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketingAuthNumber: 88780; mrpNumber: PL/H/0863/001)
Maximum Dose
9 mg/day

Related trials

Other published trials that may interest you.