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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT01694732
Eligibility Criteria:
Inclusion Criteria:
* Patients smokers (= 10 cigarettes per day in the last year)
* Affected by a chronic obstructive pulmonary disease.
* Presenting a recent exacerbation having led to at least a 24-hour hospitalization in pneumology or intensive care unit.
* Inclusion during hospitalization.
* Motivated to quit smoking
* Able to understand the information and give a written consent.
* Available for a follow-up of 1 year.
Exclusion Criteria:
* Refusal or unable to consent.
* Unaffiliated or not entitled to the National Health Insurance Coverage.
* Absence of a chronic obstructive pulmonary disease according to the criteria ATS / ERS.
* presenting a contraindication to the pharmacotherapy (i.e. the active substance: tartrate of varénicline or one of the excipients)
* actively participating in other smoking cessation trials.
* Pregnancy: declared or planned in 14 months.
* breastfeeding.
* Women old enough to procreate without reliable contraception.
* History of anorexia nervosa or bulimia.
* History of a severe depression and having required a medicinal treatment in 5 years.
* History of 2 or several episodes of severe depression and having required a medicinal treatment.
* Personal or family History of suicide attempt.
* History or current presence of dementia, a bipolar disease, a psychosis, a panic attack.
* Taken by psychotropic medicines in the inclusion excepted those prescribed to hypnotic aim and antidepressant medicine of the class of the inhibitors of the recapture of the sérotonine prescribed for a not severe depression
* Presence of a depression detected by means of the questionnaire HAD (not inclusion if the total of the sub-scale D is \> 8 or if the total of scales A + D is \> 16) and/or PHQ-9 (not inclusion if score \> 9).
* SGOT or SGPT \> 2 fold upper limit of normal, the hepatic cirrhosis, the acute hepatitis.
* Renal insufficiency (clearance of the creatinine \< 30 ml / min according to the formula of Cockcroft).
* Excessive consumption of alcohol (more than 21 glasses a week for the men, more than 14 glasses of wines a week to them Women).
* Use of marijuana or other forms of tobacco during the study.
* Use of other stimulant drugs (ephedrine, phenylephrine) or appetite suppressants during the study.
* Life expectancy of ≤ 12-months (ex: patients affected by a chronic disease in terminal phase).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01694732
Study Brief:
Protocol Section:
NCT01694732