12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Smoking Cessation
Interventions
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

All Listed Sponsors
collaborator

Universidad de Córdoba

OTHER

lead

Maimónides Biomedical Research Institute of Córdoba

OTHER