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Introduction: Cannabis products have been used in the management of headaches in adults and may play a role in pediatric chronic pain. Canadian pediatricians report increasing use of cannabis for the management of chronic headaches, despite no well-controlled studies to inform its dosing, safety, and effectiveness. The aim of our clinical trial is to determine the dosing and safety of a Cannabidiol (CBD)-enriched Cannabis Herbal Extract (CHE) for the treatment of chronic headaches in adolescents. Methods and analysis: Youth, parents, and an expert steering committee co-designed this tolerability study. Twenty adolescents (aged 14 to 17 years), with a chronic migraine diagnosis for more than 6 months that has not responded to other therapies will be enrolled into an open label, dose escalation study across three Canadian sites. Study participants will receive escalating doses of a CBD-enriched CHE (MPL-001 with a THC:CBD of 1:25), starting at 0.2–0.4 mg/kg of CBD per day and escalating monthly up to 0.8–1.0 mg/kg of CBD per day. The primary objective of this study is to determine the safety and tolerability of CBD-enriched CHE in adolescents with chronic migraine. Secondary objectives of this study will inform the development of subsequent randomized controlled trials and include investigating the relationship between the dose escalation and change in the frequency of headache, impact and intensity of pain, changes in sleep, mood, function, and quality of life. Exploratory outcomes include investigating steady-state trough plasma levels of bioactive cannabinoids and investigating how pharmacogenetic profiles affect cannabinoid metabolism among adolescents receiving CBD-enriched CHE. Discussion: This protocol was co-designed with youth and describes a tolerability clinical trial of CBD-enriched CHE in adolescents with chronic headaches that have not responded to conventional therapies. This study is the first clinical trial on cannabis products in adolescents with chronic headaches and will inform the development of future comparative effectiveness clinical trials. Trial registration: CAN-CHA trial is registered with ClinicalTrials.gov with a number of register NCT05337033. [ABSTRACT FROM AUTHOR]

Youth have a right to participate in research that will inform the care that they receive. Engagement with children and young people has been shown to improve rates of enrollment and retention in clinical trials as well as reduce research waste. The aim of the study is to gain practical insight on the design of trials specifically on (1) recruitment and retention preferences, (2) potential barriers to research, and (3) study design optimization. Based on this youth engagement, we will co‐design two clinical trials in headaches with youth. Two recruitment strategies were used to recruit 16 youth from across Canada (aged 15–18 years) from an existing youth group, the KidsCan Young Persons' Research Advisory Group (YPRAG) and a new youth group in collaboration with Solutions for Kids in Pain (SKIP). Four virtual, semi‐structured discussion groups were held between April and December 2020, which included pre‐circulated materials and utilized two distinct upcoming planned trials as examples for specific methods feedback. Individual engagement evaluations were completed following the final group session using the Public and Patient Engagement Evaluation Tool. Descriptive results were shared with participants prior to publication to ensure appropriate interpretation. The discussion was centred around three themes: recruitment and retention preferences, potential barriers to participation, and study design optimization. Youth indicated that they would prefer to be contacted for a potential study directly by their physician (not over social media), that they would like to develop rapport with study staff, and that one of the barriers to participation is the time commitment. The youth also provided feedback on the design of the clinical trial including outcome measurement tools, data collection, and engagement methods. Feedback on the virtual format of the engagement events indicated that participants appreciated the ease of the online discussion and that the open‐ended discussion allowed for easy exchange of ideas. They felt that despite a gender imbalance (towards females) it was an overall inclusive environment. All participants reported believing that their engagement will make a difference to the work of the research team in designing the clinical trials. Perspectives from a diverse group of youth meaningfully improved the design and conduct of two clinical trials for headaches in children. This study provides a framework for future researchers to engage youth in the co‐design of clinical trials using online engagement sessions. [ABSTRACT FROM AUTHOR]

Background: Loneliness, the perception that one's social relationships do not meet the desire for social connection, is a risk factor for poor mental and physical health. Adolescents with chronic pain experience higher rates of peer loneliness which persists over time. Previous studies used a single loneliness measure, limiting our understanding of the nature of their loneliness. This study describes the types of peer loneliness (intimate, relational, and collective) experienced by these adolescents and the impact that peer loneliness has on pain-related outcomes., Methods: A cross-sectional online survey was completed by 128 Canadian adolescents aged 12-18 years who experienced pain for at least 3 months. Validated measures captured demographics, pain-related characteristics, types of peer-related loneliness, measures of social well-being, and mental and physical health outcomes., Results: Friedman's tests of z-scores indicate that participants equally experienced dyadic, relational, and collective peer loneliness. MANCOVA revealed that those who identify as Black were lonelier after controlling for socioeconomic status. Multiple regression showed that loneliness was a robust predicter of worse scores on social well-being and mental health outcomes with males and females equally impacted by loneliness. Despite moderate correlations between loneliness and pain interference and pain intensity, loneliness did not predict school absences, suggesting that loneliness' influence on physical pain outcomes may be temporally earlier (e.g. contribute to pain chronification)., Conclusions: Peer loneliness among adolescents with chronic pain negatively impacts their social well-being and mental health outcomes. Interventions addressing loneliness to target all three types of peer loneliness may be key to improving pain-related outcomes., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published with license by Taylor & Francis Group, LLC.)