Grant: Operating Grant: SickKids-CIHR-IHDCYH New Investigator Grants

Chronic daily headache (CDH) is one of the most common chronic pain syndromes in children and adolescents. CDH can result in school absenteeism, withdrawal from social activities and cause significant stress for parents. It is typically associated with other comorbidities making a multifaceted approach necessary. Despite treatment, many patients will not have resolution of headache symptoms. Cannabis has successfully managed chronic headaches in adults. Canadian pediatricians report the increasing use of cannabis to manage CDH, despite there being no well controlled studies to inform dosing, safety or effectiveness. Our objectives are to: 1) meaningfully engage parents and young persons in the design of clinical trials on cannabis products, 2) determine the dosing and safety of a cannabidiol-enriched cannabis product for the treatment of CDH in adolescents, 3) design a randomized clinical trial to evaluate the efficacy of a cannabis product. Our methods include engagement with two young persons’ advisory groups, an open label dose finding study, and the development of a protocol for an innovative randomized clinical trial with an integrated knowledge translation strategy. Young person advisory groups and parents will provide input on protocol, outcome measures, and study documents. The dose finding study will recruit 20 adolescents (14-18years) from two chronic pain clinics. Participants will receive scheduled dose increases and we will measure plasma concentrations of cannabinoids/metabolites. Our findings will be used to design a blinded, innovative randomized clinical trial of a cannabis product for CDH across multiple sites. CDH is common, reduces quality of life and current treatments are insufficient. This project will directly evaluate the safety and inform dosing of cannabis products used in adolescents with CDH. The successful outcomes from this research project have the potential to create meaningful impact given the high prevalence of CDH, severe morbidity, and current lack of effective treatment options