ADHDPhase 4NCT07838311

Delayed-Release, Extended-Release Methylphenidate (Jornay PM) for Adolescents and Young Adults With Attention-Deficit/Hyperactivity Disorder and Cannabis Use Disorder

A Phase 4 study testing Delayed-release, extended-release methylphenidate in people with ADHD and Cannabis Use Disorder, run by Massachusetts General Hospital at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 16 to 26 years
Conditions the study is for: ADHD, Cannabis Use Disorder
What is being tested?: Delayed-release, extended-release methylphenidate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Nov 2026to Nov 2029
Phase: Phase 4

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 16 to 26 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or female subjects, 16-26 years of age at the time of consent
An established diagnosis of ADHD and CUD based on the DSM-5
ADHD severity of 4 or greater as determined by the Clinical Global Impression-Severity (CGI-S) scale
Subject must be interested in or currently participating in some type of treatment for their CUD, including, but not limited to, outpatient individual therapy, outpatient group therapy, CUD-directed pharmacotherapy, Marijuana Anonymous, Alcoholics Anonymous, Narcotics Anonymous, or Smart Recovery
Subject must report cannabis use on at least 3 of the 7 days prior to study enrollment
Subject must have a level of understanding sufficient to communicate intelligently with the investigator and study staff to complete study tasks in English
Subject must be willing to cooperate with all tests and examinations required by the protocol
Subject must be domiciled in the state of Massachusetts

Who cannot join

Subjects who are pregnant or nursing, or subjects unable or unwilling to use birth control. Birth control includes, but is not limited to:
i. hormonal methods, such as birth control pills, patches, injections, vaginal rings, or implants
ii. barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
iii. intrauterine device (IUD)
iv. abstinence (no sex)
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

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Subjects with major untreated psychopathology, psychosis, suicidality, or concurrent active non-nicotine SUD other than CUD that, in the investigators' opinion, place them at risk for the adverse effects or need for additional care
Subjects who are unwilling or unable to comply with study procedures
Subjects who refuse additional substance-related interventions
Subjects with known medical risk factors (e.g., known untreated hypertension, arrhythmia, premature family history of sudden death) and active symptoms that, in the investigators' opinion, place them at risk for untoward adverse effects
Subjects with previous poor response or poor tolerability to methylphenidate despite an adequate trial
Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
Subjects who are unable to swallow large capsules
Subjects with a known allergy to study medication or known hypersensitivity to methylphenidate HCL or product components
Subjects with concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days
Subjects who have ever taken Jornay PM in the past

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aaron R Quiggle, MD, MS contact

617-726-0730

aquiggle@mgh.harvard.edu

United States1 site

Massachusetts General Hospital, 55 Fruit Street, Yawkey 6A
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Randomized Controlled Study of Delayed-Release, Extended-Release Methylphenidate (Jornay PM) in Adolescents and Young Adults With Attention-Deficit/Hyperactivity Disorder and Co-Occurring Cannabis Use Disorder

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.

Conditions: ADHD, Cannabis Use Disorder
Being tested: Delayed-release, extended-release methylphenidate, Placebo
Keywords: ADHD, Cannabis Use Disorder, Methylphenidate, Attention-deficit hyperactivity disorder, Cannabis, Substance use disorder, Substance use
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Marijuana Abuse, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Delayed-release, extended-release methylphenidateDrug
Also called Jornay PM
Active treatment arm
PlaceboDrug
Placebo treatment arm

Study groups in NCT07838311
Study group	Role	What they receive
Delayed-release, extended release methylphenidate	Active comparator	Not described Receives: Drug: Delayed-release, extended-release methylphenidate
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

ADHD Symptom Change as Measured by Adult ADHD Investigator Symptom Rating Scale (AISRS)
ADHD symptom severity will be assessed using the AISRS, which consists of 18 items scored from 0 to 3, yielding a total score of 0-54; higher scores indicate greater symptom severity. The outcome is change in AISRS total score from baseline to week 12.
Measured: Baseline to week 12

Secondary outcomes (1)

Change in Cannabis Use as Measured by Timeline Followback (TLFB)
Cannabis use will be assessed using TLFB to determine the number of cannabis-use days within a 28-day period, ranging from 0 to 28. The outcome is change in the number of cannabis-use days during the preceding 28 days from baseline to week 12.
Measured: The 28 days preceding treatment initiation and the final 28 days of treatment (weeks 9-12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2026Nov 2029

First posted24 Sep 2026
Study startNov 2026 (estimated)
Primary completionNov 2029 (estimated)
Study completionNov 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ADHDStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 66 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07838311
Sponsor's protocol ID: 2026P001748
Other IDs: K12DA000357
Status last verified: Sep 2026
First submitted: 17 Sep 2026
Last updated: 28 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Aaron R Quiggle, MD, MS

617-726-0730

aquiggle@mgh.harvard.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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