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
Massachusetts General Hospital
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.
Eligibility
- Age range
- 16–26 years
- Sex
- All
- Healthy volunteers
- No
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, Narcotics Anonymous, or Smart Recovery 5. Subject must report cannabis use on at…
Interventions
- DrugDelayed-release, extended-release methylphenidate
Active treatment arm
- DrugPlacebo
Placebo treatment arm
Location
- Massachusetts General Hospital, 55 Fruit Street, Yawkey 6ABoston, Massachusetts