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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT03090269
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with cocaine/crack/amphetamine derivate dependence using Diagnostic and Statistical Manual of Mental Disorders (DSM V) (and International Classification of Diseases (ICD 10)) and willing to be abstinent.
* Having a cocaine/crack positive urinary test.
* Effective contraception for women of childbearing age.
* Willing to participate.
* Registered at social insurance/security.
* Being able to give consent.
* Reachable by telephone.
Exclusion Criteria:
* Dependence on alcohol and/or other substances.
* Hypersensitivity to the active compound methylphenidate or to filler.
* Glaucoma.
* Phaeochromocytoma
* Family history or diagnosis of Gilles de la Tourette syndrome.
* During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors.
* History of hyperthyroidism or of thyrotoxicosis.
* Preexisting cardiovascular problems including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrythmias and channelopathies, (disorders caused by the dysfunction of ionic channels).
* Preexisting cerebrovascular disorders, cerebral aneurism, vascular abnormalities including vasculitis or stroke.
* Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
* Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled)
* Suicidal tendencies or characterized suicidal syndrome.
* Pregnancy, breast-feeding or absence of any contraception for female participants.
* Unstabilized psychiatric comorbidity likely to compromise adherence to treatment.
* Comorbidity or handicap likely to corrupt evaluation.
* Organic pathology severe enough according to the investigator, likely to comprise adequate surveillance during the trial.
* Patient about to leave the area for a period of time preventing his/her adequate participation in the trial.
* Insufficient motivation.
* Participation in another clinical trial with an on-going exclusion period at the time of the pre-inclusion visit.
* Lack of medical insurance.
* Unreachable by phone.
* Patient on mandatory treatment.
* Patient with legal incapacity (under guardianship or curatorship)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03090269
Study Brief:
Protocol Section:
NCT03090269