12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence (MEDSEC-CTA12)

Maimónides Biomedical Research Institute of Córdoba

Status and phase

Not yet enrolling

Phase 4

Conditions

Smoking Cessation

Study type

Interventional

Funder types

Other

Identifiers

NCT06579846

MEDSEC-CTA12

Details and patient eligibility

About

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 cytisinicline. This protocol aims to evaluate the efficacy of the synergistic effect of combining structured physical exercise, brief counseling, and cytisinicline administration in achieving smoking cessation. The study will be an experimental, multicenter, randomized, and controlled trial with two parallel arms, conducted by a multidisciplinary team within the primary care setting of the Andalusian public health system, with a 12-month follow-up. The estimated sample size is 75 participants per arm. One of the study arms will include a structured exercise program aligned with the recently approved regional Andalusian health plan.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.