Delayed-Release, Extended-Release Methylphenidate (Jornay PM) for Adolescents and Young Adults With ADHD and Cannabis Use Disorder

NCT ID
NCT07838311
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
Massachusetts General Hospital
Conditions
ADHD, Cannabis Use Disorder

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 66 participants (Estimated).

What is being studied

  • Intervention: Acids, Carbocyclic
  • Intervention: Carboxylic Acids
  • Drug: Delayed-release, extended-release methylphenidate
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 1-Ring
  • Intervention: Methylphenidate
  • Intervention: Organic Chemicals
  • Intervention: Phenylacetates
  • Intervention: Piperidines
  • Drug: Placebo

Who may be eligible

Ages
16 Years to 26 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 DSM-5 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, or Narcotics Anonymous 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: 1. 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) 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 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 hypersensitivity 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

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Massachusetts, United States: 1

Sample of listed locations

  • Massachusetts General Hospital, 55 Fruit Street, Yawkey 6A — Boston, Massachusetts, 02114, United States — Site recruitment status not specified in the registry data

Study details

Start date
November 1, 2026
Primary completion date
November 1, 2029
Completion date
November 1, 2029
First posted
September 24, 2026
Collaborators
Collegium Pharmaceutical, Inc., National Institute on Drug Abuse (NIDA)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07838311
Registry last updated
September 24, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07838311 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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