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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT02892851
Eligibility Criteria:
Inclusion Criteria:
* severe and resistant Cocaine Dependence for 5 years defined as:
* cocaine dependence (DSM IV),
* preferential use of cocaine in base form (crack or free-base) through smoke,
* non response to at least two well-conducted treatment with at least a stay in aftercare,
* severe physical complications (defined as a history of myocardial infarction, stroke).
* psychotic syndromes induced recurrent, severe lung disease "crack-lungs") occurred due to crack consumption and whose association with the crack use is known to the patient
* age between 30 and 55 years
* patient affiliated to a social security scheme
* patient signed an informed consent after receiving written information on the proposed procedure
Exclusion Criteria:
* a current opioid dependence will not be a criterion of non inclusion if the patient is undergoing substitution treatment (methadone or buprenorphine) and not injection of opiates for at least six months.
* patient trust
* pregnant, nursing or of childbearing potential without effective contraception
* current use of the intravenous route for the administration of the drugs is the risk of infection
* VIH infection or VHC unstabilized,
* cardiovascular and / or brain state is not compatible with the surgery,
* other disorder on Axis I not linked to cocaine use except:
* current or past dependence to nicotine,
* abuse or dependence on other psychoactive substances over a lifetime in remission for more than 6 months,
* current opioid dependence: if the patient is undergoing substitution treatment (methadone or buprenorphine) and not injection of opiates for at least 6 months,
* when other psychiatric disorders induced by substances.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT02892851
Study Brief:
Protocol Section:
NCT02892851