Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 16, 2021
Open Peer Review Period: Jun 16, 2021 - Aug 11, 2021
Date Accepted: Aug 30, 2021
(closed for review but you can still tweet)
Pharmacokinetics and perceptions of children and young adults using Cannabis for ADHD and ODD: A Mixed-Methods Proof-of-Concept Study
ABSTRACT
Background:
Despite the lack of evidence on the use of Cannabis for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), the growing perception that Cannabis is safe has led more patients and caregivers to self-medicate. Some psychiatrists now authorize medicinal Cannabis for patients with ADHD with features of Oppositional Defiant Disorder (ODD) to curtail the unregulated (i.e. self-medicated) use of recreational Cannabis or to offer a therapeutic option to those who continue to experience symptoms after exhausting all other treatment options.
Objective:
To explore the perceived effectiveness and pharmacokinetics of Cannabis in youth and young adults, who are currently taking it as part of their treatment plan for ADHD with features of ODD, under the supervision of a psychiatrist.
Methods:
Patients between the ages of 12 and 25 with a diagnosis of ADHD and features of ODD who are currently taking Cannabis herbal extract (in a THC:CBD 1:20 ratio) as a treatment adjunct to stimulant pharmacotherapy will be recruited. A sample size of 10-20 is estimated. The study interview will consist of: 1) validated symptom rating scales (SNAP-IV (90-item), PHQ-9, and SCARED tool, which measure symptoms of ADHD and ODD, depression, and anxiety, respectively); 2) a semi-structured interview to probe the experiences of using Cannabis; and 3) a Cannabis side effects survey. A Cannabis product sample as well as two blood samples (a trough level and 2-h post-dose level) will be collected to measure plasma concentrations of cannabinoids and relevant metabolites (THC, CBD, 11-hydroxy-THC, 7-hydroxy-CBD, cannabichromene, 11-nor-9-carboxy-tertrahydrocannabinol) using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Self-report rating scales (SNAP-IV, SCARED, PHQ-9) will be scored according to standard protocols and compared to retrospective scores obtained from the participant’s chart. Demographic variables (age, weight, race), symptoms scores, and blood levels (peaks and troughs) of THC, CBD, CBC, and metabolites will be summarized using descriptive statistics. Relationships between plasma concentrations and symptom scores will be determined using ANOVA and multiple regression analysis determine associations between plasma concentrations and demographic variables (age, weight, ethnicity). The qualitative data will be audio-recorded and transcribed and organized into themes.
Results:
The protocol was approved by the Biomedical Research Ethics Board at the Univerity of Sasaktchewan (protocol #1726) and recruitment began in May of 2021.
Conclusions:
This proof-of-concept study will explore the potential treatment effectiveness of medical Cannabis in participants with ADHD and ODD using a mixed methods approach to inform the design of patient-oriented research in this area.
Citation
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Copyright
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