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Not yet recruiting NCT06579846

12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence

Phase IV Interventional Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cytisinicline and exercise, Cytisinicline.
Who it may be relevant to
Registry conditions: Smoking Cessation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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 wi
  • Drug Cytisinicline
    Same intervention as the experimental group without directed exercise prescription

Primary outcome measures

  • Smoking [Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Smoking cessation [Time frame: Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Carbon monoxide exhaled air [Time frame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365]
Secondary outcome measures (10)
  • Blood pressure [Time frame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Weight [Time frame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Body mass index [Time frame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Physical dependence on nicotine [Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Psychological dependence on smoking [Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Motivation to quit smoking [Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Alcohol consumption [Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Physical activity [Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Self-efficacy for physical activity [Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365]
  • Heart rate in rest [Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06579846 · MEDSEC-CTA12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗