Status:
NOT_YET_RECRUITING
12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Collaborating Sponsors:
Universidad de Córdoba
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Current scientific evidence demonstrates the relationship between good physical fitness and a lower incidence of certain chronic diseases, including smoking, as well as the effectiveness of cytisinicl...
Eligibility Criteria
Inclusion
- Aged between 18 and 65 years.
- Smoking a minimum of 10 cigarettes per day.
- In the contemplation or action stage according to Prochaska and DiClemente's Transtheoretical Model.
- Prepared to initiate smoking cessation treatment imminently and with commitment.
- Demonstrating a high level of nicotine dependence, with a Fagerström test score of 7 or higher.
- Exhibiting significant motivation to quit smoking, as indicated by a Richmond test score of 6 or higher.
- Having made at least one prior attempt to quit smoking within the past year.
- Enrolled in or covered by the Andalusian Public Health System.
Exclusion
- Individuals with medical conditions that contraindicate participation in physical exercise, including but not limited to malignant hypertension, heart failure, hyperthyroidism, peripheral arterial disease, or other conditions deemed by the research team to pose a risk of adverse events or significantly impair adherence to the study.
- Individuals who have experienced changes in their usual treatment regimen within the past 90 days.
- Individuals unable to provide informed consent.
- Individuals with pathological conditions that significantly reduce life expectancy to less than 5 years.
- Individuals with contraindications as specified in the product information for cytisinicline , such as pregnancy, breastfeeding, hypersensitivity to cytisinicline, unstable angina, recent myocardial infarction, clinically significant arrhythmias, or recent stroke.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06579846
Start Date
January 1 2025
End Date
December 31 2025
Last Update
September 4 2024
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