Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities
Status:
Not yet recruiting
Trial end date:
2024-03-31
Target enrollment:
Participant gender:
Summary
Innovative treatments are urgently needed for severe behavioural problems (SBPs) in adults
with intellectual and developmental disabilities (IDD). Although a synthetic cannabinoid,
nabilone may be a plausible and safe alternative to treat SBP, safety and efficacy of
nabilone in people with IDD has never been evaluated. The investigators propose to conduct
this first-ever Phase I pre-pilot open-label clinical trial to collect data on the
tolerability and safety profile of nabilone in adults with IDD, and explore changes in SBP
pre- and post-treatment. The results will inform a next-stage pilot randomized controlled
trial, followed by a fully powered trial eventually.