Pharmacokinetics and Perceptions of Children and Young Adults Using Cannabis for Attention-Deficit/Hyperactivity Disorder and Oppositional Defiant Disorder: Protocol for a Mixed Methods Proof-of-Concept Study
H. Mansell, D. Quinn, L. Kelly, M. Szafron, J. Alcorn
JMIR Research Protocols June 16, 2021 DOI: 10.2196/31281 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Clinical protocol Qualitative Peer reviewed |
|---|---|
| Sample size | 20 |
| Population | Youth and young adults aged 12–25 years with a diagnosis of ADHD and features of oppositional defiant disorder, currently taking cannabis herbal extract as an adjunct to stimulant pharmacotherapy |
| Measures | Swanson, Nolan, and Pelham-IV Questionnaire (SNAP-IV), 90-item; Patient Health Questionnaire, 9-item (PHQ-9); Screen for Child Anxiety Related Emotional Disorders (SCARED) |
| Topics | Cannabis |
| Key points | The protocol proposes a proof-of-concept mixed-methods study to assess whether medicinal cannabis (THC:CBD 1:20) is perceived as effective in youth and young adults with ADHD and ODD, and to characterize its pharmacokinetics and relationships between plasma cannabinoid levels and symptom scores. No results are reported; the authors state the study will inform future research. |
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 (ie, 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: This protocol aims 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 years with a diagnosis of ADHD and features of ODD, who are currently taking cannabis herbal extract (at a Δ9-tetrahydrocannabinol [THC]:cannabidiol [CBD] ratio of 1:20) as a treatment adjunct to stimulant pharmacotherapy will be recruited. A sample size of 10-20 individuals is estimated. The study interview will consist of (1) validated symptom rating scales (Swanson, Nolan, and Pelham-IV Questionnaire [SNAP-IV], 90-item; Patient Health Questionnaire, 9-item [PHQ-9]; and Screen for Child Anxiety Related Emotional Disorders [SCARED] tool to measure symptoms of ADHD and ODD, depression, and anxiety, respectively); (2) a semistructured interview to probe the experiences of using cannabis; and (3) a cannabis side effects survey. A cannabis product sample as well as 2 blood samples (a trough level and 2-hour postdose level) will be collected to measure plasma concentrations of cannabinoids and relevant metabolites (THC, CBD, 11-hydroxy-THC, 7-hydroxy-CBD, cannabichromene, and 11-nor-9-carboxy-THB) using liquid chromatography–tandem mass spectrometry (LC–MS/MS). Self-report rating scales (SNAP-IV, SCARED, and PHQ-9) will be scored in accordance with standard protocols and compared to retrospective scores obtained from the participant’s chart. Demographic variables (age, weight, and race), symptom scores, and blood levels (peaks and troughs) of THC, CBD, cannabichromene (CBC), and metabolites will be summarized using descriptive statistics. Relationships between plasma concentrations and symptom scores will be determined using analysis of variance, and multiple regression analysis will be performed to determine associations between plasma concentrations and demographic variables (age, weight, and 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 University of Saskatchewan (protocol #1726), and recruitment began in May 2021.
Conclusions: This proof-of-concept study will explore the potential treatment effectiveness of medical cannabis in participants with ADHD and ODD through a mixed methods approach to inform future research in this area. International Registered Report Identifier (IRRID) DERR1-10.2196/31281