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.
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
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)
Parallel
Delayed-release, extended-release methylphenidate
DrugActive treatment arm
Placebo
DrugPlacebo treatment arm
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.
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.
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Massachusetts General Hospital
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Collegium Pharmaceutical, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
