Smoking CessationPhase 4MEDSEC-CTA12NCT06579846
12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence
A Phase 4 study testing Cytisinicline and exercise and Cytisinicline in people with Smoking Cessation, run by Maimónides Biomedical Research Institute of Córdoba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Cytisinicline and exercise and Cytisinicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multicenter Experimental Study to Evaluate the Efficacy in Tobacco AbstinEnce At 12 Months of DIrected Exercise and CyTisinicline
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
- Being tested
- Cytisinicline and exercise, Cytisinicline
- Keywords
- Tabacco, Cytisinicline, Exercise
- Medical subject headings
- Smoking Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytisinicline and exerciseDrug
Also called Cytisinicline, 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.
CytisiniclineDrug
Same intervention as the experimental group without directed exercise prescription
| Study group | Role | What they receive |
|---|---|---|
| Cytisinicline and exercise | Experimental | Smokers who will receive directed physical exercise and brief counseling while undergoing treatment according to the care process. Receives: 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. Receives: Drug: Cytisinicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking
Number of cigarettes smoked daily.
Measured: 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.
Measured: 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).
Measured: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
Secondary outcomes (10)
Blood pressure
Blood pressure is measured in the non-dominant arm three times, with a 5-minute gap between each measurement, using an automatic oscillometer (Omron M3 Intellisense HEM-75051-EV; IOMRON Healthcare Europe) equipped with a child-specific cuff. The average of the three measurements is recorded for both systolic and diastolic blood pressure. The mean blood pressure values are expressed in mmHg.
Measured: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
Weight
Weight in grams is measured by the precision weighing scale model Tanita 780PMA.
Measured: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
Body mass index
Body mass index in kilograms per square meter is calculated.
Measured: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
Physical dependence on nicotine
Physical dependence on nicotine measured by the Fagerström Test for Nicotine Dependence (FTND). This test consists of 6 questions, and each question has response options with assigned scores. The total score is the sum of the response scores and ranges from 0 to 10 points. The scoring scale is interpreted as follows:
0-2 points: Low dependence. 3-4 points: Low to moderate dependence. 5 points: Moderate dependence. 6-7 points: High dependence. 8-10 points: Very high dependence.
Measured: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Psychological dependence on smoking
Physical dependence on nicotine measured by the Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ). The GN-SBQ consists of 11 questions, each with response options ranging from 0 (never) to 4 (always), forming a 5-point Likert scale.
The total test score is obtained by summing the responses to all the questions, resulting in a possible score range of 0 to 44 points. The scores are interpreted as follows:
0-10 points: Low behavioral dependence on tobacco. 11-22 points: Moderate behavioral dependence. 23-33 points: High behavioral dependence. 34-44 points: Very high behavioral dependence.
Measured: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Motivation to quit smoking
Physical dependence on nicotine measured by the Richmond Smoking Withdrawal Questionnaire. This test consists of 4 questions. Each question has response options with scores ranging from 0 to 3 points. The total score is obtained by summing the responses, resulting in a possible range of 0 to 10 points.
The interpretation of the scores is as follows:
0-3 points: Low dependence on nicotine. 4-5 points: Moderate dependence. 6-7 points: High dependence. 8-10 points: Very high dependence.
Measured: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Alcohol consumption
Weekly alcohol consumption. Unit of measurement is Standard Drink Units
Measured: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Physical activity
Time physical activity performed daily will be measured with the Global Physical Activity Questionnaire (GPAQ) of the World Health Organization (WHO). It collects quantitative information on physical activity in three different domains:
- Physical activity at work (including occupational activity and domestic work); 2)Transport (physical activity related to transportation, such as walking or cycling); 3) Recreational physical activity (sports, exercise, leisure).
For each of these domains, the GPAQ asks respondents about the frequency (days per week) and duration (minutes per day) of the physical activities performed. Additionally, the GPAQ also inquires about the time spent on sedentary activities.
The collected information is used to calculate the respondent's level of physical activity, which is categorized into levels such as low, moderate, or high physical activity according to WHO guidelines.
Measured: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Self-efficacy for physical activity
Self-efficacy for physical activity measured by the Benisovich Test. The scale used in this test is an 11-point Likert scale, ranging from 0 to 10, where:
0 indicates "not confident at all" or "I have no confidence at all that I could do this." 10 indicates "completely confident" or "I have complete confidence that I could do this."
Measured: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Heart rate in rest
The unit of measure is beats per minute (bpm).
Measured: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Córdoba
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579846
- Sponsor's protocol ID
- MEDSEC-CTA12
- Acronym
- MEDSEC-CTA12
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Experimental Study to Evaluate the Efficacy in Tobacco AbstinEnce At 12 Months of DIrected Exercise and CyTisinicline
- ClinicalTrials.gov ID
- NCT06579846
- Acronym / sponsor ID
- MEDSEC-CTA12 / MEDSEC-CTA12
- Conditions
- Smoking Cessation
- Keywords
- Tabacco, Cytisinicline, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Universidad de Córdoba
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytisinicline and exercise | Experimental | Drug: Cytisinicline and exerciseSmokers who will receive directed physical exercise and brief counseling while undergoing treatment according to the care process. |
| Cytisinicline | Active comparator | Drug: CytisiniclineSmokers who will receive an informational leaflet and brief counseling when they begin cytisinicline treatment, according to the care process. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytisinicline and exerciseAlso: Cytisinicline, ExerciseDoctors 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 and exercise |
| CytisiniclineSame intervention as the experimental group without directed exercise prescription | Drug | Cytisinicline |
Primary outcome
Smoking
Time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365
Number of cigarettes smoked daily.
Smoking cessation
Time frame: Day 30; Day; 60; Day 90; Day 180; Day 365
Dichotomous variable (yes/not) asking in the clinical history.
Carbon monoxide exhaled air
Time frame: Day 0; Day 30; Day; 60; Day 90; Day 180; Day 365
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).
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cytisinicline and exercise and Cytisinicline in people with Smoking Cessation, run by Maimónides Biomedical Research Institute of Córdoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Ranchal Sanchez, MD, PhD (+34957213700, en1rasaa@uco.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking (time frame: Day 0; Day 7; Day 30; Day; 60; Day 90; Day 180; Day 365). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.