Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity

Phase

Condition

Learning Disorders

Substance Abuse

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

N/A

Clinical Study ID

NCT03481959

P140313

Ages 12-25
All Genders

Study 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 and worldwide.

Cannabis is the first illicit drug consumed by adolescents in France. His experimentation progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental health has been shown by several studies. In particular Attention Deficit Hyperactivity Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood protects the consumption of psychoactive products during adolescence or adulthood. However, to our knowledge there is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a cannabis user, was a positive prognostic factor in the decrease in cannabis use.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 treatmentwith methylphenidate (confirmed by MINI or MINI Kid); absence of BPD (tracked by theself-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 theduration of the test

Exclusion

Exclusion Criteria: 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 tomethylphenidate or any of the excipients, glaucoma, pheochromocytoma,treatment by nonselective irreversible inhibitors of the mono-amine oxidase (MAOI) and also for atleast 14 days after stopping treatment with an MAOI because of the risk ofhypertensive thrust,Treatment by other sympathomimetic indirect or sympathomimetic (oral and/or nasal way) alpha,Hyperthyroidism or wrong,diagnosis or history of severedepression, anorexia nervosa or disorders anorexia, suicidal tendencies, mooddisorders, psychotic symptoms, mania, schizophrenia, psychopathic personalitydisorder, or limit (borderline), occlusal,diagnosis or history (affective) bipolardisorder severe (for type 1) and episodic (and poorly controlled), pre-existingcardiovascular disorders including severe hypertension, heart failure, pad angina,congenital heart disease with hemodynamic impact; cardiomyopathy, myocardialinfarction, arrhythmias and channelopathies (disorders caused by a dysfunction of ionchannels) that can potentially be life-threatening, pre-existence of disorders,stroke, cerebral aneurysm, vascular abnormalities, including stroke or Vasculitis andmajor Patient protected by law.

Study Design

May 07, 2019

September 01, 2020

Study Description

Cannabis is the first illicit drug consumed by adolescents in France. His experimentation progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental health has been shown by several studies. In particular Attention Deficit Hyperactivity Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood protects against the use of cannabis during adolescence or adulthood. However, there is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a cannabis user, was a positive prognostic factor in the decrease in cannabis use.

Hypothesis: The hypothesis of this study is that patients diagnosed with ADHD and cannabis-treated patients treated with methylphenidate will decrease their number of days of cannabis use compared to ADHD patients receiving placebo.

Originality and Innovative There is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a problematic cannabis user, was a positive prognostic factor in decreasing cannabis use.

Moreover, there is not enough team in addiction trained in the detection of attention deficit disorder which is now recognized as a factor of vulnerability for the development of addictions. This project is the opportunity for a training in the detection of the ADHD in the adolescent and the young adult of the professionals of the addiction and the setting up of a treatment by Methylphenidate as well as its handling.

Connect with a study center

Peyret
Paris, 75019
France
Site Not Available

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