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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01538394
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 65 years old
* Smoking 20 or more cigarettes per day
* Wants to stop smoking(seeking treatment)
* No period of smoking abstinence longer than 3 months in the past year
* Be able to give informed consent to participate
* Complete the study questionnaires
* Female smokers will be eligible providing they are not breastfeeding, pregnant (negative pregnancy test) or at risk of becoming pregnant
Exclusion Criteria:
* Previous use of nicotine transdermal patches or varenicline (VRN) in the last 6 months
* Cigar, pipe and oral tobacco users who do not smoke 20 or more cigarettes per day
* Those who meet the criteria contra-indicating nicotine patches or VRN use, as described in the Summaries Product Characteristics
* Those with previous severe adverse reactions to nicotine patch or to VRN
* Those currently taking either medication for smoking cessation that they are unwilling to stop or taking medication with a known influence on smoking cessation that they should not stop (e.g. nortriptyline for depression)
* Those who are non-Spanish neither Catalan speakers
* Those deemed unsuitable for the study by their smoking cessation physicians; -- Unstable diseases within the previous 6 months
* Diagnoses of or treatment for major depression last 6 months or psychotic disorder; or drug or alcohol dependence within the previous 12 months
* Skin disorders that cause a difficulty of nicotine absorption by patches as Psoriases as well as general dermatitis
* Clinically significant renal or hepatic impairment or dysfunction
* Pregnant or breast-feeding women
* women who do not use neither want to use any effective anticonceptive method.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01538394
Study Brief:
Protocol Section:
NCT01538394