Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT05885659
Eligibility Criteria:
Inclusion Criteria:
* Being aged 18 or over.
* Having smoked 10 or more cigarettes per day within the last year.
* Meeting nicotine dependence criteria (Diagnostic and Statistical Manual of Mental Disorders, fifth Ed.; American Psychiatric Association, 2013).
* Complying with baseline scores equal to or higher than 4 particles per million (ppm) of carbon monoxide (CO) levels in expired air and more than 80 ng/ml of cotinine levels in urine.
* Having a diagnosis of T2DM and receiving routine medical treatment for this condition in their corresponding health services.
* Participants who may present subclinical symptoms of both depression and anxiety will be included.
* Participants who present comorbid physical problems such as cardiorespiratory problems will be included in the study, since smokers with T2DM have a higher incidence of such physical conditions.
Exclusion Criteria:
* Meeting comorbidity with severe psychological or psychiatric disorders, such as bipolar and related disorders, personality disorders, eating disorders (for example, anorexia or bulimia), any disorder included within the schizophrenia spectrum and substance use related disorders (that is, other than nicotine dependence).
* Having a diagnosis of Diabetes Mellitus Type 1 (DMT1) or gestational diabetes.
* Meeting comorbid physical or neurological problems impairing communication. Moreover, we will exclude those patients who do not know the Spanish language enough to hold a fluid conversation.
* Meeting the criteria for any physical health condition whose medical treatment is incompatible or contraindicated for the development of the smoking cessation treatment.
* Receiving other psychological or pharmacological treatment for smoking cessation at the time of recruitment.
* Not being able to attend all treatment sessions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05885659
Study Brief:
Protocol Section:
NCT05885659