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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?

The goal of this clinical trial is to look at how delayed-release, extended-release methylphenidate (Jornay PM), an FDA-approved medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD), works to treat ADHD symptoms in adolescents and young adults (ages 16-26) with ADHD and Cannabis Use Disorder. Researchers will compare delayed-release, extended-release methylphenidate to a placebo (a look-alike substance that contains no drug).

Participants will be assigned to take either delayed-release, extended-release methylphenidate or a placebo every night over 12 weeks. Throughout the study, participants will provide urine samples and complete questionnaires about their ADHD symptoms, cannabis use, and other substance use.

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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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+

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