NCT06579846

12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence

Multicenter Experimental Study to Evaluate the Efficacy in Tobacco AbstinEnce At 12 Months of DIrected Exercise and CyTisinicline

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Cytisinicline	Same intervention as the experimental group without directed exercise prescription

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-08-30
• Last updated: 2024-09-04