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Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities

NCT05273320 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Intellectual Disability
  • Developmental Disability
  • Aggression
  • Behavior Problem

Interventions

DRUG

Nabilone

Nabilone capsules at a maximum dose of 1 mg twice a day

Sponsors & Collaborators

  • Hsiang-Yuan Lin

    lead OTHER

Principal Investigators

  • Hsiang-Yuan Lin, MD · Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2025-08-14
Completion
2025-08-14

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273320 on ClinicalTrials.gov