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Nabilone treatment for severe behavioral problems in adults with intellectual and developmental disabilities: Protocol for a phase I open-label clinical trial.

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Abi-Jaoude, Elia 
Desarkar, Pushpal 
Wang, Wei 
Ameis, Stephanie H 


Severe behavioral problems (SBPs) are common contributors to morbidity and reduced quality of life for adults with intellectual and developmental disabilities (IDD) and their families. Current medications for SBPs show equivocal effectiveness and are associated with a high risk of side effects. New and safe treatments are urgently needed. While preliminary studies suggest that medical cannabinoids, particularly the synthetic cannabinoid nabilone, are plausible treatment options for SBPs in adults with IDD, data on the tolerability, safety and efficacy of nabilone in this population has never been investigated. Thus, we propose this first-ever Phase I pre-pilot open-label clinical trial to obtain preliminary data on the adherence, tolerability and safety profiles of nabilone in adults with IDD, and explore changes in SBPs pre- to post-treatment. We hypothesize that nabilone has favorable tolerability and safety profile for adults with IDD. The preliminary results will inform the next-stage pilot randomized controlled trials, followed by fully powered clinical trials eventually. This research helps fill the evidence gap in the use of cannabinoids in individuals with IDD to meet the needs of patients, families, and service providers.


Acknowledgements: We thank the self-advocates and family advisors at the Azrieli Adult Neurodevelopmental Centre, Centre for Addiction and Mental Health, Toronto, Ontario, Canada, who helped us evaluate the feasibility of the design of this study and edit the language in the informed consent form and assent form to facilitate the readability of these documents for people with IDD.

Funder: Department of Psychiatry, University of Toronto

Funder: CAMH Academic Health Science Centre Alternative Funding Plan (AHSC AFP)


Adult, Child, Humans, Cannabinoids, Developmental Disabilities, Intellectual Disability, Problem Behavior, Quality of Life, Clinical Trials, Phase I as Topic

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PLoS One

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Public Library of Science (PLoS)