Attention Deficit Hyperactivity Disorder (ADHD)Phase 3METHACANNCT03481959
Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
A Phase 3 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2019to 1 Sep 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Methylphenidate, Matching Placebo
- Keywords
- TDAH, Methylphenidate, Cannabis
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
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 PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Methylphenidate |
| Matching Placebo | Placebo comparator | Not described Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (9)
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
Measured: 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
Measured: 4,8,12 weeks and 12 months
ADHD Rating scale IV score
The scale evaluates the frequency of behavior, the level of behavioral discomfort and the developmental level.
Measured: 4,8,12 weeks and 12 months
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
Measured: one day, 12 weeks and one year
the score of the Hooked on nicotine checklist (HONC)
HONC is a self-administered questionnaire that assesses nicotine addiction.
Measured: one day, 4,8,12 weeks and 12 months
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
Measured: one day, 4,8,12 weeks and 12 months
Psychiatric comorbidities
Measured: one day, 12 weeks and 12 months
Consumption of other drugs
Measured: one day, 12 weeks and 12 months
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.
Measured: one day, 4,8,12 weeks and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start7 May 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: insufficient recrutement in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peyret Emmanuelle, PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481959
- Sponsor's protocol ID
- P140313
- Acronym
- METHACAN
- Status last verified
- Nov 2020
- First submitted
- 12 Mar 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35201607
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity
- ClinicalTrials.gov ID
- NCT03481959
- Acronym / sponsor ID
- METHACAN / P140313
- Keywords
- TDAH, Methylphenidate, Cannabis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recrutement in the study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: MethylphenidateMethylphenidate 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). |
| Matching Placebo | Placebo comparator | Other: Matching Placebo |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateMethylphenidate 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). | Drug | Methylphenidate |
| Matching PlaceboMethylphenidate 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). | Other | Matching Placebo |
Primary outcome
Number of days of use of cannabis
Time frame: 12 weeks
Number of days of use of cannabis in the past 21 days measured in 12 weeks by the TimeLine Follow Back (TLFB 21)
9 secondary outcomes
Number of days of use of cannabis
Time frame: 4,8,12 weeks and 12 months
Average daily consumption of cannabis in the last 21 days
Time frame: 4,8,12 weeks and 12 months
ADHD Rating scale IV score
Time frame: 4,8,12 weeks and 12 months
advanced CAST score
Time frame: one day, 12 weeks and one year
the score of the Hooked on nicotine checklist (HONC)
Time frame: one day, 4,8,12 weeks and 12 months
the score of French version of the Tobacco Craving Questionnaire (FTCQ-12)
Time frame: one day, 4,8,12 weeks and 12 months
Psychiatric comorbidities
Time frame: one day, 12 weeks and 12 months
Consumption of other drugs
Time frame: one day, 12 weeks and 12 months
Score of Overall Clinical Improvement Scale (CGI-S)
Time frame: one day, 4,8,12 weeks and 12 months
Results and safety
The study was stopped early (reason given: insufficient recrutement in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 35201607Boesen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peyret Emmanuelle, PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient recrutement in the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days of use of cannabis (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.