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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
Active treatment arm
Placebo treatment arm
Massachusetts General Hospital, 55 Fruit Street, Yawkey 6A
Boston, Massachusetts, United States
ADHD Symptom Reduction 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
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)
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