12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence

NCT ID: NCT06579846

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cytisinicline and exercise

Smokers who will receive directed physical exercise and brief counseling while undergoing treatment according to the care process.

Group Type: EXPERIMENTAL

Cytisinicline and exercise

Intervention Type: DRUG

Doctors will provide brief, personalized counseling anti-smoking plan. This counseling will support smokers in the determination-action phase of behavior change.

Physicians will administer cytisine as follows: 1 tablet every 2 hours (maximum 6 per day) from days 1-3; every 2.5 hours (maximum 5 per day) from days 4-12; every 3 hours (maximum 4 per day) from days 13-16; every 5 hours (maximum 3 per day) from days 17-20; and 1-2 tablets per day (maximum 2 per day) from days 21-25.

Participants will follow a combined aerobic and strength exercise program. This includes at least 150 minutes of moderate-intensity aerobic physical activity per week, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of both. Aerobic activity should be performed in sessions lasting at least 10 minutes.

Cytisinicline

Smokers who will receive an informational leaflet and brief counseling when they begin cytisinicline treatment, according to the care process.

Group Type: ACTIVE_COMPARATOR

Cytisinicline

Intervention Type: DRUG

Same intervention as the experimental group without directed exercise prescription

Interventions

Cytisinicline and exercise

Doctors will provide brief, personalized counseling anti-smoking plan. This counseling will support smokers in the determination-action phase of behavior change.

Physicians will administer cytisine as follows: 1 tablet every 2 hours (maximum 6 per day) from days 1-3; every 2.5 hours (maximum 5 per day) from days 4-12; every 3 hours (maximum 4 per day) from days 13-16; every 5 hours (maximum 3 per day) from days 17-20; and 1-2 tablets per day (maximum 2 per day) from days 21-25.

Participants will follow a combined aerobic and strength exercise program. This includes at least 150 minutes of moderate-intensity aerobic physical activity per week, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of both. Aerobic activity should be performed in sessions lasting at least 10 minutes.

Intervention Type: DRUG

Cytisinicline

Same intervention as the experimental group without directed exercise prescription

Intervention Type: DRUG

Other Intervention Names

Cytisinicline; Exercise

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Córdoba

OTHER

Sponsor Role: collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Antonio Ranchal Sanchez, MD, PhD

Role: CONTACT

en1rasaa@uco.es

+34957213700

Other Identifiers

MEDSEC-CTA12

Identifier Type: -

Identifier Source: org_study_id