12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence

NCT06579846 | Not Yet Recruiting Phase 4

• 1 other identifier: MEDSEC-CTA12
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Keywords

Tabacco; Cytisinicline; Exercise

Outcome Measures

Primary Outcomes (3)

• Smoking

  Number of cigarettes smoked daily.

  Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365

• Smoking cessation

  Dichotomous variable (yes/not) asking in the clinical history.

  Day 30; Day; 60; Day 90; Day 180; Day 365

• Carbon monoxide exhaled air

  Carbon monoxide in the subject's exhaled air. It will be measured with a Co-oximeter of the brand "Co Check", code 01PLS18B, with a sensitivity of 1 ppm and accuracy (repeatability) of 2%. The unit of measurement of the variable is parts per million (ppm).

  Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365

Secondary Outcomes (10)

• Blood pressure

  Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365

• Weight

  Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365

• Body mass index

  Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365

• Physical dependence on nicotine

  Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365

• Psychological dependence on smoking

  Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365

Study Arms (2)

Cytisinicline and exercise

EXPERIMENTAL

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

Drug: Cytisinicline and exercise

Cytisinicline

ACTIVE COMPARATOR

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

Drug: Cytisinicline

Interventions

Cytisinicline and exercise 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.

Also known as: Cytisinicline, Exercise

Cytisinicline and exercise

Cytisinicline DRUG

Same intervention as the experimental group without directed exercise prescription

Cytisinicline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Universidad de Córdoba: collaborator

MeSH Terms

Conditions

Smoking Cessation; Motor Activity

Interventions

cytisine; Exercise

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Antonio Ranchal Sanchez, MD, PhD

CONTACT

+34957213700; en1rasaa@uco.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share