Health Services, Murdoch Childrens Research Institute, Parkville, Victoria, Australia
The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
BMJ Open. 2020 Mar 8;10(3):e034362. doi: 10.1136/bmjopen-2019-034362.
Severe behavioural problems (SBPs) are a common contributor to morbidity and reduced quality of life in children with intellectual disability (ID). Current medication treatment for SBP is associated with a high risk of side effects. Innovative and safe interventions are urgently needed. Anecdotal reports and preliminary research suggest that medicinal cannabis may be effective in managing SBP in children with developmental disabilities. In particular, cannabidiol (CBD) may be a plausible and safe alternative to current medications. Families who are in urgent need of solutions are seeking cannabis for their ID children with SBP. However there is no evidence from randomised controlled trials to support the use of CBD for SBP. This pilot study aims to investigate the feasibility of conducting a randomised placebo-controlled trial of CBD to improve SBP in children with ID.
This is a single-site, double-blind, parallel-group, randomised, placebo-controlled pilot study of 10 participants comparing 98% CBD oil with placebo in reducing SBP in children aged 8-16 years with ID. Eligible participants will be randomised 1:1 to receive either CBD 20 mg/kg/day or placebo for 8 weeks. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires. Safety outcomes and adverse events will be recorded. All data will be reported using descriptive statistics. These data will inform the design of a full scale randomised controlled trial to evaluate the efficacy of CBD in this patient group.
This protocol has received ethics approval from the Royal Children's Hospital ethics committee (Human Research Ethics Committee no. 38236). Results will be disseminated through peer-reviewed journals, professional networks, conferences and social media.
ACTRN12618001852246.
严重行为问题（SBPs）是导致智障儿童发病率和生活质量下降的常见因素。目前针对 SBP 的药物治疗存在副作用风险高的问题，因此急需创新且安全的干预措施。有传闻和初步研究表明，药用大麻可能对管理发育障碍儿童的 SBP 有效。特别是，大麻二酚（CBD）可能是目前药物的合理且安全的替代品。有严重需求的家庭正在为智障伴有 SBP 的儿童寻求大麻。然而，目前尚无随机对照试验证据支持 CBD 用于 SBP。本试点研究旨在探讨 CBD 治疗智障儿童 SBP 的随机安慰剂对照试验的可行性。
这是一项单中心、双盲、平行组、随机、安慰剂对照的试点研究，纳入 10 名参与者，比较 8-16 岁 ID 儿童中 98% CBD 油与安慰剂对 SBP 的影响。符合条件的参与者将以 1:1 的比例随机分为接受 CBD 20mg/kg/天或安慰剂 8 周。将收集有关所有研究组成部分的可行性和可接受性的数据，包括招募、脱落率、研究就诊出席率、方案依从性以及父母问卷的时间负担。记录安全性结果和不良事件。所有数据将使用描述性统计进行报告。这些数据将为评估 CBD 在该患者群体中的疗效的全面随机对照试验设计提供信息。
该方案已获得皇家儿童医院伦理委员会（伦理委员会编号 38236）的批准。结果将通过同行评审期刊、专业网络、会议和社交媒体进行传播。
ACTRN12618001852246。
