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

NCT03481959 | Terminated Phase 3

• 1 other identifier: P140313
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

TDAH; Methylphenidate; Cannabis

Outcome Measures

Primary Outcomes (1)

• Number of days of use of cannabis

  Number of days of use of cannabis in the past 21 days measured in 12 weeks by the TimeLine Follow Back (TLFB 21)

  12 weeks

Secondary Outcomes (9)

• Number of days of use of cannabis

  4,8,12 weeks and 12 months

• Average daily consumption of cannabis in the last 21 days

  4,8,12 weeks and 12 months

• ADHD Rating scale IV score

  4,8,12 weeks and 12 months

• advanced CAST score

  one day, 12 weeks and one year

• the score of the Hooked on nicotine checklist (HONC)

  one day, 4,8,12 weeks and 12 months

Study Arms (2)

Methylphenidate

EXPERIMENTAL

Methylphenidate delay shape, 10 and 30 mg capsules. Treatment should be started at a dose of 10 mg per day or 20 mg/d (depending on the weight of patients), with increasing weekly, according to the clinical tolerance, in order to get an effective dose on the symptoms of ADHD to S4, not more than 1 mg/kg/d (capped at 60 mg/d).

Drug: Methylphenidate

Matching Placebo

PLACEBO COMPARATOR

Other: Matching Placebo

Interventions

Methylphenidate DRUG

Methylphenidate delay shape, 10 and 30 mg and matching Placebo capsules. Treatment should be started at a dose of 10 mg per day or 20 mg/d (depending on the weight of patients), with increasing weekly, according to the clinical tolerance, in order to get an effective dose on the symptoms of ADHD to S4, not more than 1 mg/kg/d (capped at 60 mg/d). This gradual dose treatment will be resumed in the same manner in M3 at the beginning of the phase in open, allowing the respect of the average of the ADHD support (no), without loss of chance for the Group at 3 months, because it is customary to discontinue treatment during holiday periods).

Methylphenidate

Matching Placebo OTHER

Methylphenidate delay shape, 10 and 30 mg and matching Placebo capsules. Treatment should be started at a dose of 10 mg per day or 20 mg/d (depending on the weight of patients), with increasing weekly, according to the clinical tolerance, in order to get an effective dose on the symptoms of ADHD to S4, not more than 1 mg/kg/d (capped at 60 mg/d). This gradual dose treatment will be resumed in the same manner in M3 at the beginning of the phase in open, allowing the respect of the average of the ADHD support (no), without loss of chance for the Group at 3 months, because it is customary to discontinue treatment during holiday periods).

Matching Placebo

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Peyret

Paris, 75019, France

Location

Related Publications (1)

• Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.

  PMID: 35201607 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Marijuana Abuse

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peyret Emmanuelle, PHD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 29, 2018
• Study Start: May 7, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 25, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)