Clinical trial NCT06579846: 12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence
Official title: Multicenter Experimental Study to Evaluate the Efficacy in Tobacco AbstinEnce At 12 Months of DIrected Exercise and CyTisinicline
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Tabacco
Cytisinicline
Exercise
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Universidad de Córdoba
First posted: 2024-08-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Smoking
timeFrame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Smoking cessation
timeFrame: Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Carbon monoxide exhaled air
timeFrame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
Secondary outcomes:
measure: Blood pressure
timeFrame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Weight
timeFrame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Body mass index
timeFrame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Physical dependence on nicotine
timeFrame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Psychological dependence on smoking
timeFrame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Motivation to quit smoking
timeFrame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Alcohol consumption
timeFrame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Physical activity
timeFrame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Self-efficacy for physical activity
timeFrame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
measure: Heart rate in rest
timeFrame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Other outcomes:
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