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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02134002
Eligibility Criteria:
Inclusion Criteria:
* men aged 18 years ans less than or equal 65
* diagnosis of cocaine dependence according to DSM IV
* hospitalization for cocaine withdrawal
* ability to understand and give informed consent orally ans in writing
* affiliation to a social security
* patient with a normal ECG and normal blood pressure
Exclusion Criteria:
* Psychiatric comorbidity : psychotic disorder, manic episode , major depressive current , high suicide risk , assessed by structured interview of the Mini International Neuropsychiatric Interview
* Neurological histories: neurological deficit focused, organic cerebral disorder , epilepsy, dementia
* Severe hepatic insufficiency
* Severe renal insufficiency
* Severe respiratory
* Diabetes
* Hypersensitivity disulfiram or any of the other components
* Neuropsychological disorder
* Preexisting cardiovascular disorders
* Hypersensitivity to methylphenidate or any of the excipients
* Hyperthyroidism or thyrotoxicosis
* Glaucoma
* Pheochromocytoma
* Preexisting cerebrovascular disorders
* Patient presenting an allergy to the wheat
* HIV or HCV seropositivity
* Family or personal history of motor tics, and syndrome of Gilles Tourette
* Any disorder that may interfere with adherence to treatment
* Pharmacological treatment interfering with catecholamines
* Participation in another clinical trial or exclusion period of a previous clinical trial
* Contraindications to magnetic resonance imaging
* People under placement measure
* Hypersensitivity to any component of NIQUITIN
* Skin disorder that may interfere with the use of a transdermal patch
* Patient under treatment with irreversible inhibitors of mono- amine oxidase inhibitors (MAOIs ) , and for at least 14 days following the stop of the treatment by an IMAO.
* Diagnosis or history of bipolar disorders (affective ) episodic and severe ( type 1 )"
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02134002
Study Brief:
Protocol Section:
NCT02134002