Methylphenidate for ADHD and Cannabis Use Disorder

AR
Overseen ByAaron R Quiggle, MD, MS
Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Massachusetts General Hospital
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of delayed-release, extended-release methylphenidate, already approved for ADHD, in individuals with both ADHD and Cannabis Use Disorder. Researchers aim to determine if this medication reduces ADHD symptoms more effectively than a placebo (a pill with no active medicine). Participants will take the medication or placebo nightly for 12 weeks and report on their symptoms and cannabis use. This trial may suit individuals aged 16-26 who have both ADHD and Cannabis Use Disorder, frequently use cannabis, and are interested in or currently receiving help for their cannabis use. As a Phase 4 trial, this research explores how an FDA-approved treatment can benefit more patients.

What is the safety track record for delayed-release, extended-release methylphenidate?

Research has shown that delayed-release, extended-release methylphenidate is generally well-tolerated. Studies have found that this medication significantly improves daily functioning in people with ADHD compared to a placebo. In these studies, patients did not report any serious side effects. The FDA has already approved this type of methylphenidate for treating ADHD, indicating its well-established safety.

However, methylphenidate can be misused or abused, so taking it only as prescribed is crucial. There may also be risks when using this medication with cannabis, as some studies suggest it can increase side effects. Participants in this trial should discuss any concerns with their healthcare provider.12345

Why are researchers enthusiastic about this study treatment?

Most treatments for ADHD and Cannabis Use Disorder typically involve standard stimulant medications or behavioral therapies. However, delayed-release, extended-release methylphenidate is unique because it offers a novel delivery method designed to provide a steady release of medication throughout the day. This could potentially enhance symptom management with fewer doses, which is convenient for patients who struggle with adherence. Researchers are excited about this treatment because it could improve focus and reduce impulsivity with potentially lower side effects, making it a promising option for those dealing with both ADHD and Cannabis Use Disorder.

What is the effectiveness track record for delayed-release, extended-release methylphenidate in treating ADHD and Cannabis Use Disorder?

Research has shown that a special form of methylphenidate, which releases slowly in the body, effectively treats ADHD. Studies have found that it greatly improves attention and reduces impulsive behavior in both teenagers and adults with ADHD. This trial will compare the effects of delayed-release, extended-release methylphenidate with a placebo. The medication helps people focus better and make decisions more easily. For those with both ADHD and substance use issues, such as cannabis problems, evidence suggests that stimulants like methylphenidate can be used safely and effectively. The FDA has already approved this treatment for ADHD, supporting its use in managing symptoms of this condition.678910

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults ages 16-26 who have both ADHD and problems with cannabis use. Participants should be generally healthy aside from these conditions.

Inclusion Criteria

ADHD severity of 4 or greater as determined by the Clinical Global Impression-Severity (CGI-S) scale
Subject must report cannabis use on at least 3 of the 7 days prior to study enrollment
Subject must be domiciled in the state of Massachusetts
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Exclusion Criteria

Subjects who present a negative urine dipstick result for cannabis use at baseline or report fewer than 3 use days of cannabis in week preceding study enrollment
Subjects with major untreated psychopathology, psychosis, suicidality, or concurrent active non-nicotine SUD other than CUD that place them at risk for adverse effects or need for additional care
Subjects with known medical risk factors (e.g., untreated hypertension, arrhythmia, premature family history of sudden death) and active symptoms placing them at risk for adverse effects
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either delayed-release, extended-release methylphenidate or a placebo every night over 12 weeks. They provide urine samples and complete questionnaires about ADHD symptoms, cannabis use, and other substance use.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Delayed-release, extended-release methylphenidate

Trial Overview

The study tests whether delayed-release, extended-release methylphenidate (Jornay PM) helps reduce ADHD symptoms in people with cannabis use disorder, compared to a placebo. Treatment lasts 12 weeks, with nightly doses assigned randomly.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Delayed-release, extended release methylphenidateActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Collegium Pharmaceutical, Inc.

Industry Sponsor

Trials
3
Recruited
920+

Citations

(PDF) Effectiveness and Tolerability of Methylphenidate in ...

The euphoric effects of OROS-MPH did not significantly differ between the adolescent and adult samples. Adults rated OROS-MPH as more effective in treating ADHD ...

Drug Class Review Pharmacologic Treatments for ...

The purpose of Drug Effectiveness Review Project reports is to make available information regarding the comparative clinical effectiveness and harms ...

The Effects of Methylphenidate on Cognitive Control in Active ...

MPH has been shown to have cognitive enhancing effects in healthy subjects (58, 59) and in patients with attention deficit hyperactivity disorder (ADHD),

Methylphenidate for children and adolescents with ...

Methylphenidate may improve teacher-rated general behaviour versus to 0.83; I2 = 81%; 4 trials, 608 participants; very low-certainty evidence).

Attention Deficit/Hyperactivity Disorder and Substance Abuse

Data collected from several clinical trials suggest that stimulants can be used safely to treat co-occurring ADHD and substance use disorders. However, the ...

A Randomized, Double-Blind, Placebo-Controlled Study of ...

Conclusion DR/ER-MPH was well tolerated and demonstrated significant improvements versus placebo in functional impairment throughout the day ...

A Randomized, Double-Blind, Placebo-Controlled Study of ...

DR/ER-MPH was well tolerated and demonstrated significant improvements versus placebo in functional impairment throughout the day across ...

N205-831 Methylphenidate hydrochloride extended- ...

Statistically significant differences favoring methylphenidate ER were demonstrated on the primary efficacy endpoint, mean change from baseline ...

Multiscale assessment of treatment efficacy in adults with ADHD

The rates of responders were 50% in the MPH ER and 18% in the placebo group. MPH ER treatment was well tolerated. of one year could be ...

(PDF) Efficacy and Safety of Multilayer, Extended-Release ...

Conclusions SDX/d-MPH showed significant improvement in ADHD symptoms compared with placebo in children 6–12 years of age, with a rapid onset ...