Tobacco Use DisorderNCT07474623
Effects of Nicotine Dependence on Multidimensional Health Outcomes
A study testing Comprehensive Clinical Assessment in people with Tobacco Use Disorder and Nicotine Dependence, Cigarettes, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
Nicotine, a major toxic component of cigarette smoke, together with carbon monoxide (CO), constitutes a significant environmental exposure with systemic effects. Beyond its addictive potential, chronic nicotine exposure may induce inflammation, oxidative stress, tissue hypoxia, and autonomic imbalance, potentially… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Nicotine Dependence, Cigarettes
- What is being tested?
- Comprehensive Clinical Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Regular cigarette use for at least the past 6 months
- No history of respiratory, cardiovascular, or neurological/psychiatric disease
- No recent history of surgery or trauma that could affect respiratory muscles
- No current acute infection (especially upper or lower respiratory tract infections)
Who cannot join
- Presence of chronic respiratory diseases such as COPD or
- History of cardiovascular disease
- Diagnosed neurological or psychiatric disorders
- history of surgery or trauma affecting the respiratory muscles within the last 3 months
- Pregnancy or suspected pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Relationship Between Nicotine Addiction Level and Respiratory Muscle Strength, Functional Capacity, Cognitive Functions, Pain, Quality of Life, Physical Activity Level, and Sleep Quality
Nicotine, a major toxic component of cigarette smoke, together with carbon monoxide (CO), constitutes a significant environmental exposure with systemic effects. Beyond its addictive potential, chronic nicotine exposure may induce inflammation, oxidative stress, tissue hypoxia, and autonomic imbalance, potentially impairing respiratory muscle strength, functional capacity, and overall physical performance. Additionally, nicotine dependence has been associated with sleep disturbances, cognitive dysfunction, altered pain perception, and reduced quality of life.
Although previous studies have examined individual effects of smoking on specific health outcomes, research addressing these multidimensional impacts within a comprehensive framework remains limited. Therefore, this study aims to investigate the relationship between nicotine dependence level and respiratory muscle strength, functional capacity, cognitive functions, pain, quality of life, physical activity level, and sleep quality, in order to provide a more holistic understanding of the clinical consequences of nicotine dependence.
Read the detailed description
One of the toxic components found in cigarette smoke, nicotine, together with carbon monoxide (CO), represents an important environmental exposure. Nicotine is the primary component responsible for the addictive potential of tobacco products and rapidly enters the systemic circulation, spreading to both the central and peripheral nervous systems. In addition, the systemic effects of nicotine may influence the oxygenation capacity of respiratory muscles and overall functional performance. Long-term nicotine exposure may trigger inflammatory and oxidative stress responses, which are thought to contribute to reduced respiratory muscle performance.
Sleep disturbances and attention-concentration problems associated with nicotine dependence negatively affect both quality of life and cognitive functions. Studies examining the effects of smoking status on functional capacity have shown that nicotine exposure plays a limiting role in exercise capacity and activities of daily living. One study reported that smokers had significantly lower exercise capacity and physical activity levels in daily life compared to non-smokers. The same study also demonstrated that smoking has a negative impact on the physical components of quality of life and may adversely affect functional independence.
Chronic tobacco exposure contributes to hyperalgesia through multidimensional mechanisms, including dysfunction of central pain modulation pathways, activation of proinflammatory processes, and tissue damage. Research has shown that nicotine dependence sensitizes pain perception, increases pain intensity, and complicates pain management processes. Nicotine has also been found to be directly associated with prolonged sleep latency, reduced total sleep time, and decreased slow-wave sleep, which has restorative properties. Considering that the pathophysiology of common sleep disorders has not yet been fully elucidated, we hypothesize that there may also be a relationship between CO exposure and sleep disturbances.
Chronic nicotine exposure may lead to tissue hypoxia, thereby reducing physical endurance and participation in daily activities. Furthermore, nicotine-induced mitochondrial dysfunction, oxidative stress, and autonomic imbalance may negatively affect general health perception and psychological well-being through symptoms such as fatigue, headache, and cognitive fog. Impaired sleep quality and the presence of cardiorespiratory symptoms may further limit social, occupational, and personal functioning.
Taken together, these effects suggest that nicotine dependence may lead to reductions in quality of life components and cognitive functions. Given the limited number of studies addressing the multifaceted effects of nicotine within a holistic framework, we anticipate that our study-investigating the relationship between nicotine dependence level and respiratory muscle strength, functional capacity, cognitive functions, pain, quality of life, physical activity level, and sleep quality-will contribute significantly to filling existing gaps in the literature.
- Being tested
- Comprehensive Clinical Assessment
- Keywords
- Nicotine Dependence, Respiratory Muscle Strength, Quality of Life
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Clinical AssessmentOther
Participants will undergo a comprehensive clinical assessment including evaluation of nicotine dependence level (Fagerström Test for Nicotine Dependence), respiratory muscle strength (MIP, MEP), functional capacity (6-Minute Walk Test), cognitive function (MoCA), pain (VAS and SF-MPQ), quality of life (SF-36), physical activity level (IPAQ-SF), sleep quality (PSQI), addiction behavior model (SOCRATES), and health beliefs (Health Belief Model Scale). No therapeutic intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Adult Smokers | Other | Adult individuals who use cigarettes will be enrolled in this observational study. Participants will be evaluated for nicotine dependence level using the Fagerström Test for Nicotine Dependence and will undergo assessments of respiratory muscle strength (MIP, MEP), functional capacity (6-Minute Walk Test), cognitive function (MoCA), pain (VAS/SF-MPQ), quality of life (SF-36), physical activity level (IPAQ-SF), sleep quality (PSQI), addiction behavior model (SOCRATES), and health beliefs (Health Belief Model Scale). No intervention will be applied. Receives: Other: Comprehensive Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Nicotine Dependence
Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND). The test was originally developed by Karl O. Fagerström, and its Turkish validity and reliability study was conducted in 2003. The FTND consists of six items. The total score obtained from participants' responses determines the level of nicotine dependence. Scores of 0-2 indicate very low dependence, 3-4 low dependence, 5 moderate dependence, 6-7 high dependence, and 8-10 very high dependence. This evaluation provides an important criterion for determining the need for intervention related to cigarette dependence.
Measured: At baseline
Maximal Inspiratory Pressure (MIP)
Maximal inspiratory pressure will be measured using the Pony-Fx pulmonary function testing device according to ATS/ERS standards. Assessments will be performed in the seated position with a nose clip. At least three maneuvers will be obtained, and the highest value will be used for analysis. Unit of measure: cmH2O.
Measured: At baseline
Maximal Expiratory Pressure (MEP)
Maximal expiratory pressure will be measured using the Pony-Fx pulmonary function testing device according to ATS/ERS standards. Assessments will be performed in the seated position with a nose clip. At least three maneuvers will be obtained, and the highest value will be used for analysis. Unit of measure: cmH2O.
Measured: At baseline
Assessment of Functional Capacity
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will perform the test in a 30-meter corridor. Two tests will be conducted, and the longer walking distance will be used for analysis. Rest periods will be permitted and included in the total test duration. The walked distance will be expressed in meters (m). Predicted walking distance values will be calculated using standard reference equations.
Measured: At baseline
Assessment of Cognitive Functions
Cognitive functions will be evaluated using the Montreal Cognitive Assessment (MoCA). MoCA is a comprehensive screening tool that assesses attention, concentration, memory, language skills, executive functions, visuospatial abilities, abstraction, calculation, and orientation. The total score ranges from 0 to 30, and scores of 21 and above will be considered indicative of normal cognitive function. The Turkish version has established validity and reliability.
Measured: At baseline
Assessment of Pain
Pain will be evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ) to assess both qualitative and quantitative aspects of pain. The scale consists of three sections. The first section includes 15 descriptors (11 sensory and 4 affective). Participants rate each descriptor from 0 (none) to 3 (severe). The second section evaluates overall pain intensity using a visual comparison scale. The third section assesses present pain intensity on a scale from 0 (no pain) to 5 (unbearable pain). Scores will be analyzed separately as sensory, affective, and total pain scores. The Turkish version has demonstrated validity and reliability.
Measured: At baseline
Assessment of Quality of Life
Quality of life will be assessed using the Short Form-36 (SF-36) Health Survey. This scale evaluates general health status across eight domains: physical functioning, role limitations due to physical problems, social functioning, role limitations due to emotional problems, vitality, pain, mental health, and general health perception. Each domain is scored from 0 to 100, with higher scores indicating better quality of life. The Turkish version has established validity and reliability.
Measured: At baseline
Assessment of Physical Activity Level
Physical activity level will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). This questionnaire collects information about walking, moderate-intensity activity, vigorous-intensity activity, and sedentary time during the past seven days. It consists of seven items grouped into four sections.
Based on participants' responses, weekly physical activity levels will be calculated and classified as low, moderate, or high. Metabolic equivalent (MET) values will be used in the calculation (vigorous activity: 8 METs; moderate activity: 4 METs; walking: 3.3 METs), and weekly MET-minutes will be determined for each activity type.
Measured: At baseline
Assessment of Sleep Quality
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). The scale consists of 24 items, 19 of which are self-rated and 5 rated by a bed partner or roommate. It includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored between 0 and 3, yielding a total score ranging from 0 to 21. Items completed by a partner or roommate are not included in the total score calculation. Lower total scores indicate better sleep quality. The Turkish version has demonstrated acceptable reliability.
Measured: At baseline
Addiction Behavior Model
Addiction behavior will be evaluated using the Stages of Change Questionnaire (SOCRATES). This 19-item self-report scale assesses readiness to change and motivation for treatment. The Turkish version has established validity and reliability.
Measured: At baseline
Assessment of Health Behaviors
Health behaviors will be assessed using the Health Belief Model Scale (HBM). The Health Belief Model is a psychosocial framework developed to understand health-related behaviors. It examines perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action. The Health Belief Model Scale is used to measure these perceptions, and adaptations for smoking cessation behavior are available in Turkey.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adult individuals who use cigarettes will be included.
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Ferruh Taşpınar, Prof.Dr., Principal investigator, İzmir democracy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474623
- Sponsor's protocol ID
- Nicotine35
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Nicotine Addiction Level and Respiratory Muscle Strength, Functional Capacity, Cognitive Functions, Pain, Quality of Life, Physical Activity Level, and Sleep Quality
- ClinicalTrials.gov ID
- NCT07474623
- Acronym / sponsor ID
- Nicotine35
- Keywords
- Nicotine Dependence, Respiratory Muscle Strength, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
Nicotine, a major toxic component of cigarette smoke, together with carbon monoxide (CO), constitutes a significant environmental exposure with systemic effects. Beyond its addictive potential, chronic nicotine exposure may induce inflammation, oxidative stress, tissue hypoxia, and autonomic imbalance, potentially impairing respiratory muscle strength, functional capacity, and overall physical performance. Additionally, nicotine dependence has been associated with sleep disturbances, cognitive dysfunction, altered pain perception, and reduced quality of life.
Although previous studies have examined individual effects of smoking on specific health outcomes, research addressing these multidimensional impacts within a comprehensive framework remains limited. Therefore, this study aims to investigate the relationship between nicotine dependence level and respiratory muscle strength, functional capacity, cognitive functions, pain, quality of life, physical activity level, and sleep quality, in order to provide a more holistic understanding of the clinical consequences of nicotine dependence.
Detailed description
One of the toxic components found in cigarette smoke, nicotine, together with carbon monoxide (CO), represents an important environmental exposure. Nicotine is the primary component responsible for the addictive potential of tobacco products and rapidly enters the systemic circulation, spreading to both the central and peripheral nervous systems. In addition, the systemic effects of nicotine may influence the oxygenation capacity of respiratory muscles and overall functional performance. Long-term nicotine exposure may trigger inflammatory and oxidative stress responses, which are thought to contribute to reduced respiratory muscle performance.
Sleep disturbances and attention-concentration problems associated with nicotine dependence negatively affect both quality of life and cognitive functions. Studies examining the effects of smoking status on functional capacity have shown that nicotine exposure plays a limiting role in exercise capacity and activities of daily living. One study reported that smokers had significantly lower exercise capacity and physical activity levels in daily life compared to non-smokers. The same study also demonstrated that smoking has a negative impact on the physical components of quality of life and may adversely affect functional independence.
Chronic tobacco exposure contributes to hyperalgesia through multidimensional mechanisms, including dysfunction of central pain modulation pathways, activation of proinflammatory processes, and tissue damage. Research has shown that nicotine dependence sensitizes pain perception, increases pain intensity, and complicates pain management processes. Nicotine has also been found to be directly associated with prolonged sleep latency, reduced total sleep time, and decreased slow-wave sleep, which has restorative properties. Considering that the pathophysiology of common sleep disorders has not yet been fully elucidated, we hypothesize that there may also be a relationship between CO exposure and sleep disturbances.
Chronic nicotine exposure may lead to tissue hypoxia, thereby reducing physical endurance and participation in daily activities. Furthermore, nicotine-induced mitochondrial dysfunction, oxidative stress, and autonomic imbalance may negatively affect general health perception and psychological well-being through symptoms such as fatigue, headache, and cognitive fog. Impaired sleep quality and the presence of cardiorespiratory symptoms may further limit social, occupational, and personal functioning.
Taken together, these effects suggest that nicotine dependence may lead to reductions in quality of life components and cognitive functions. Given the limited number of studies addressing the multifaceted effects of nicotine within a holistic framework, we anticipate that our study-investigating the relationship between nicotine dependence level and respiratory muscle strength, functional capacity, cognitive functions, pain, quality of life, physical activity level, and sleep quality-will contribute significantly to filling existing gaps in the literature.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult individuals who use cigarettes will be included.
| Arm | Type | Receives |
|---|---|---|
| Adult Smokers | Other | Other: Comprehensive Clinical AssessmentAdult individuals who use cigarettes will be enrolled in this observational study. Participants will be evaluated for nicotine dependence level using the Fagerström Test for Nicotine Dependence and will undergo assessments of respiratory muscle strength (MIP, MEP), functional capacity (6-Minute Walk Test), cognitive function (MoCA), pain (VAS/SF-MPQ), quality of life (SF-36), physical activity level (IPAQ-SF), sleep quality (PSQI), addiction behavior model (SOCRATES), and health beliefs (Health Belief Model Scale). No intervention will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Regular cigarette use for at least the past 6 months
- No history of respiratory, cardiovascular, or neurological/psychiatric disease
- No recent history of surgery or trauma that could affect respiratory muscles
- No current acute infection (especially upper or lower respiratory tract infections)
Key exclusion criteria (5 listed)
- Presence of chronic respiratory diseases such as COPD or
- History of cardiovascular disease
- Diagnosed neurological or psychiatric disorders
- history of surgery or trauma affecting the respiratory muscles within the last 3 months
- Pregnancy or suspected pregnancy
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 |
|---|---|---|
| Comprehensive Clinical AssessmentParticipants will undergo a comprehensive clinical assessment including evaluation of nicotine dependence level (Fagerström Test for Nicotine Dependence), respiratory muscle strength (MIP, MEP), functional capacity (6-Minute Walk Test), cognitive function (MoCA), pain (VAS and SF-MPQ), quality of life (SF-36), physical activity level (IPAQ-SF), sleep quality (PSQI), addiction behavior model (SOCRATES), and health beliefs (Health Belief Model Scale). No therapeutic intervention will be administered. | Other | Adult Smokers |
Primary outcome
Assessment of Nicotine Dependence
Time frame: At baseline
Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND). The test was originally developed by Karl O. Fagerström, and its Turkish validity and reliability study was conducted in 2003. The FTND consists of six items. The total score obtained from participants' responses determines the level of nicotine dependence. Scores of 0-2 indicate very low dependence, 3-4 low dependence, 5 moderate dependence, 6-7 high dependence, and 8-10 very high dependence. This evaluation provides an important criterion for determining the need for intervention related to cigarette dependence.
Maximal Inspiratory Pressure (MIP)
Time frame: At baseline
Maximal inspiratory pressure will be measured using the Pony-Fx pulmonary function testing device according to ATS/ERS standards. Assessments will be performed in the seated position with a nose clip. At least three maneuvers will be obtained, and the highest value will be used for analysis. Unit of measure: cmH2O.
Maximal Expiratory Pressure (MEP)
Time frame: At baseline
Maximal expiratory pressure will be measured using the Pony-Fx pulmonary function testing device according to ATS/ERS standards. Assessments will be performed in the seated position with a nose clip. At least three maneuvers will be obtained, and the highest value will be used for analysis. Unit of measure: cmH2O.
Assessment of Functional Capacity
Time frame: At baseline
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Participants will perform the test in a 30-meter corridor. Two tests will be conducted, and the longer walking distance will be used for analysis. Rest periods will be permitted and included in the total test duration. The walked distance will be expressed in meters (m). Predicted walking distance values will be calculated using standard reference equations.
Assessment of Cognitive Functions
Time frame: At baseline
Cognitive functions will be evaluated using the Montreal Cognitive Assessment (MoCA). MoCA is a comprehensive screening tool that assesses attention, concentration, memory, language skills, executive functions, visuospatial abilities, abstraction, calculation, and orientation. The total score ranges from 0 to 30, and scores of 21 and above will be considered indicative of normal cognitive function. The Turkish version has established validity and reliability.
Assessment of Pain
Time frame: At baseline
Pain will be evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ) to assess both qualitative and quantitative aspects of pain. The scale consists of three sections. The first section includes 15 descriptors (11 sensory and 4 affective). Participants rate each descriptor from 0 (none) to 3 (severe). The second section evaluates overall pain intensity using a visual comparison scale. The third section assesses present pain intensity on a scale from 0 (no pain) to 5 (unbearable pain). Scores will be analyzed separately as sensory, affective, and total pain scores. The Turkish version has demonstrated validity and reliability.
Assessment of Quality of Life
Time frame: At baseline
Quality of life will be assessed using the Short Form-36 (SF-36) Health Survey. This scale evaluates general health status across eight domains: physical functioning, role limitations due to physical problems, social functioning, role limitations due to emotional problems, vitality, pain, mental health, and general health perception. Each domain is scored from 0 to 100, with higher scores indicating better quality of life. The Turkish version has established validity and reliability.
Assessment of Physical Activity Level
Time frame: At baseline
Physical activity level will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). This questionnaire collects information about walking, moderate-intensity activity, vigorous-intensity activity, and sedentary time during the past seven days. It consists of seven items grouped into four sections. Based on participants' responses, weekly physical activity levels will be calculated and classified as low, moderate, or high. Metabolic equivalent (MET) values will be used in the calculation (vigorous activity: 8 METs; moderate activity: 4 METs; walking: 3.3 METs), and weekly MET-minutes will be determined for each activity type.
Assessment of Sleep Quality
Time frame: At baseline
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). The scale consists of 24 items, 19 of which are self-rated and 5 rated by a bed partner or roommate. It includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored between 0 and 3, yielding a total score ranging from 0 to 21. Items completed by a partner or roommate are not included in the total score calculation. Lower total scores indicate better sleep quality. The Turkish version has demonstrated acceptable reliability.
Addiction Behavior Model
Time frame: At baseline
Addiction behavior will be evaluated using the Stages of Change Questionnaire (SOCRATES). This 19-item self-report scale assesses readiness to change and motivation for treatment. The Turkish version has established validity and reliability.
Assessment of Health Behaviors
Time frame: At baseline
Health behaviors will be assessed using the Health Belief Model Scale (HBM). The Health Belief Model is a psychosocial framework developed to understand health-related behaviors. It examines perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action. The Health Belief Model Scale is used to measure these perceptions, and adaptations for smoking cessation behavior are available in Turkey.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
Ferruh Taşpınar, Prof.Dr. principal investigator
İzmir democracy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Clinical Assessment in people with Tobacco Use Disorder and Nicotine Dependence, Cigarettes, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
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 4 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Taşpınar, Prof.Dr. (+90 506 680 44 26, betul.taspinar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Nicotine Dependence (time frame: At baseline). The study lists 11 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 16 Mar 2026.