Status:
TERMINATED
Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
12-25 years
Phase:
PHASE3
Brief Summary
Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that begins and takes place during adolescence. These risk behaviors are a major public health problem in France...
Detailed Description
Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that begins and takes place during adolescence. These risk behaviors are a major public health problem in France...
Eligibility Criteria
Inclusion
- Age ≥ 12 and ≤ 25 years;
- Patients from 25 to 120 kg
- ADHD diagnosed according to the criteria of the DSM - V
- ADHD-RS-IV ≥ 28 test score;
- Without medication by methylphenidate for at least 6 months;
- Lack of psychiatries co-morbidities associated with a contraindication to treatment with methylphenidate (confirmed by MINI or MINI Kid); absence of BPD (tracked by the self-administered questionnaire MSI - BPD).
- Cannabis dependence objectified by a positive qualitative urinary dosage and a score ≥ 7 to CAST questionnaire;
- Consent of parents (child/teenager \< 18 years) or young age if ≥ 18 years - patients of childbearing age agreeing to use a contraceptive method during the duration of the test
Exclusion
- Patients placed in child welfare (ASE).
- Pregnant patients or nursing
- No affiliation to a scheme of social security (beneficiary or beneficiary)
- Contraindications to treatment with methylphenidate :known hypersensitivity to methylphenidate or any of the excipients, glaucoma, pheochromocytoma,treatment by non selective irreversible inhibitors of the mono-amine oxidase (MAOI) and also for at least 14 days after stopping treatment with an MAOI because of the risk of hypertensive thrust,Treatment by other sympathomimetic indirect or sympathomimetic (oral and/or nasal way) alpha,Hyperthyroidism or wrong,diagnosis or history of severe depression, anorexia nervosa or disorders anorexia, suicidal tendencies, mood disorders, psychotic symptoms, mania, schizophrenia, psychopathic personality disorder, or limit (borderline), occlusal,diagnosis or history (affective) bipolar disorder severe (for type 1) and episodic (and poorly controlled), pre-existing cardiovascular disorders including severe hypertension, heart failure, pad angina, congenital heart disease with hemodynamic impact; cardiomyopathy, myocardial infarction, arrhythmias and channelopathies (disorders caused by a dysfunction of ion channels) that can potentially be life-threatening, pre-existence of disorders, stroke, cerebral aneurysm, vascular abnormalities, including stroke or Vasculitis and major Patient protected by law.
Key Trial Info
Start Date :
May 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03481959
Start Date
May 7 2019
End Date
September 1 2020
Last Update
April 25 2022
Active Locations (1)
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1
Peyret
Paris, France, 75019