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Not yet recruitingNCT07838311Updated Sep 28, 2026

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

A Phase 4 interventional study of Delayed-release, extended-release methylphenidate and Placebo in ADHD and Cannabis Use Disorder, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 16 Years to 26 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment

Updated Sep 28, 2026Eligibility revisedPrimary outcomes revised+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
16 Years to 26 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • ADHD
  • Cannabis Use Disorder

Keywords

  • ADHD
  • Cannabis Use Disorder
  • Methylphenidate
  • Attention-deficit hyperactivity disorder
  • Cannabis
  • Substance use disorder
  • Substance use
03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 66 is close to the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Browse Massachusetts General Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 28, 2026. See what changed

Ages eligible
16 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects, 16-26 years of age at the time of consent
  2. An established diagnosis of ADHD and CUD based on the
  3. ADHD severity of 4 or greater as determined by the Clinical Global Impression-Severity (CGI-S) scale
  4. 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
  5. Subject must report cannabis use on at least 3 of the 7 days prior to study enrollment
  6. Subject must have a level of understanding sufficient to communicate intelligently with the investigator and study staff to complete study tasks in English
  7. Subject must be willing to cooperate with all tests and examinations required by the protocol
  8. Subject must be domiciled in the state of Massachusetts

Exclusion criteria

Exclusion Criteria:

  1. Subjects who are pregnant or nursing, or subjects unable or unwilling to use . 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)
  2. 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
  3. 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
  4. Subjects who are unwilling or unable to comply with study procedures
  5. Subjects who refuse additional substance-related interventions
  6. 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
  7. Subjects with previous poor response or poor tolerability to methylphenidate despite an adequate trial
  8. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
  9. Subjects who are unable to swallow large capsules
  10. Subjects with a known allergy to study medication or known to methylphenidate HCL or product components
  11. Subjects with concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days
  12. Subjects who have ever taken Jornay PM in the past
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    Delayed-release, extended release methylphenidate

    Drug: Delayed-release, extended-release methylphenidate

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: The 28 days preceding treatment initiation and the final 28 days of treatment (weeks 9-12)

07

Study locations

1 site
  • Massachusetts General Hospital, 55 Fruit Street, Yawkey 6A
    Boston, Massachusetts 02114, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
1 inclusion criterion edited; 1 exclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedSubject 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, or Narcotics Anonymous, or Smart Recovery
Exclusion criteria
  • EditedSubjects with previous poor response or poor tolerability to methylphenidate despite an adequate trial
Sep 28, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedADHD Symptom ReductionChange as Measured by Adult ADHD Investigator Symptom Rating Scale (AISRS)Time frame: Baseline to week 12
Sep 28, 2026
Title
Delayed-Release, Extended-Release Methylphenidate (Jornay PM) for Adolescents and Young Adults With ADHDAttention-Deficit/Hyperactivity Disorder and Cannabis Use Disorder
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Eligibility 1 inclusion criterion edited; 1 exclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedSubject 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, or Narcotics Anonymous, or Smart Recovery
    Exclusion criteria
    • EditedSubjects with previous poor response or poor tolerability to methylphenidate despite an adequate trial
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedADHD Symptom ReductionChange as Measured by Adult ADHD Investigator Symptom Rating Scale (AISRS)Time frame: Baseline to week 12
    Title Delayed-Release, Extended-Release Methylphenidate (Jornay PM) for Adolescents and Young Adults With ADHDAttention-Deficit/Hyperactivity Disorder and Cannabis Use Disorder
    + 1 other change: data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07838311
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute on Drug Abuse (NIDA), Collegium Pharmaceutical, Inc.
Responsible party
Aaron Quiggle (Medical Director, Addiction Recovery Management Services (ARMS), Massachusetts General Hospital) — Principal investigator
First posted
Sep 24, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Sep 28, 2026

Study contacts

Aaron R Quiggle, MD, MS
Contact
aquiggle@mgh.harvard.edu
617-726-0730

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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