Does cannabidiol reduce severe behavioural problems in children with intellectual disability? Study protocol for a pilot single-site phase I/II randomised placebo controlled trial

BMJ Open
Daryl EfronKatrina Williams

Abstract

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 accep...Continue Reading

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Citations

Apr 24, 2021·Epilepsy & Behavior : E&B·Aaron J KaatAnne T Berg
Jul 23, 2021·Research in Developmental Disabilities·Agustín E Martínez-GonzálezJosé A Piqueras

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Methods Mentioned

BETA
pharmacotherapy

Clinical Trials Mentioned

NCT02956226
NCT03202303
NCT03848481
NCT03614663

Software Mentioned

REDCap
Research Electronic Data Capture ( REDCap )

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