Back to resultsEffectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity (METHACAN)
Primary Purpose
Attention Deficit Hyperactivity Disorder (ADHD)
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methylphenidate
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring TDAH, Methylphenidate, Cannabis
Eligibility Criteria
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 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 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 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.
Sites / Locations
- Peyret
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Methylphenidate
Matching Placebo
Arm Description
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).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Number of days of use of cannabis
The average amount of daily consumption of cannabis within the past 21 days will be assessed from the TLFB 21-4, 8, 12 weeks and 12 months
Average daily consumption of cannabis in the last 21 days
will be evaluated from the TLFB 21. The TLFB 21 makes it possible to quantify the number of daily cannabis
ADHD Rating scale IV score
The scale evaluates the frequency of behavior, the level of behavioral discomfort and the developmental level.
advanced CAST score
The CAST is a 6-item scale, each of which describes use behaviors or problems encountered in the context of cannabis use
the score of the Hooked on nicotine checklist (HONC)
HONC is a self-administered questionnaire that assesses nicotine addiction.
the score of French version of the Tobacco Craving Questionnaire (FTCQ-12)
Evaluation of tobacco craving from the four primary factors of tobacco craving: emotionality, craving in anticipation of withdrawal relief or negative mood; waiting, compulsion and anticipation
Psychiatric comorbidities
Consumption of other drugs
Score of Overall Clinical Improvement Scale (CGI-S)
Measurement of symptom severity, response to treatment and efficacy of treatment in treatment studies of patients with mental disorders.
Full Information
NCT ID
NCT03481959
First Posted
March 12, 2018
Last Updated
April 15, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03481959
Brief Title
Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
Acronym
METHACAN
Official Title
Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
insufficient recrutement in the study
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
TDAH, Methylphenidate, Cannabis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
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).
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Matching Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of days of use of cannabis
Description
Number of days of use of cannabis in the past 21 days measured in 12 weeks by the TimeLine Follow Back (TLFB 21)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of days of use of cannabis
Description
The average amount of daily consumption of cannabis within the past 21 days will be assessed from the TLFB 21-4, 8, 12 weeks and 12 months
Time Frame
4,8,12 weeks and 12 months
Title
Average daily consumption of cannabis in the last 21 days
Description
will be evaluated from the TLFB 21. The TLFB 21 makes it possible to quantify the number of daily cannabis
Time Frame
4,8,12 weeks and 12 months
Title
ADHD Rating scale IV score
Description
The scale evaluates the frequency of behavior, the level of behavioral discomfort and the developmental level.
Time Frame
4,8,12 weeks and 12 months
Title
advanced CAST score
Description
The CAST is a 6-item scale, each of which describes use behaviors or problems encountered in the context of cannabis use
Time Frame
one day, 12 weeks and one year
Title
the score of the Hooked on nicotine checklist (HONC)
Description
HONC is a self-administered questionnaire that assesses nicotine addiction.
Time Frame
one day, 4,8,12 weeks and 12 months
Title
the score of French version of the Tobacco Craving Questionnaire (FTCQ-12)
Description
Evaluation of tobacco craving from the four primary factors of tobacco craving: emotionality, craving in anticipation of withdrawal relief or negative mood; waiting, compulsion and anticipation
Time Frame
one day, 4,8,12 weeks and 12 months
Title
Psychiatric comorbidities
Time Frame
one day, 12 weeks and 12 months
Title
Consumption of other drugs
Time Frame
one day, 12 weeks and 12 months
Title
Score of Overall Clinical Improvement Scale (CGI-S)
Description
Measurement of symptom severity, response to treatment and efficacy of treatment in treatment studies of patients with mental disorders.
Time Frame
one day, 4,8,12 weeks and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peyret Emmanuelle, PHD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peyret
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35201607
Citation
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.
Results Reference
derived
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Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
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