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

NCT05273320 | Completed Phase 1 DMC

• 1 other identifier: 135-2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Developmental Disability; Aggression; Behavior Problem; Intellectual Disability

Keywords

Intellectual Disability; Developmental Disability; Aggression; Behavior Problem

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Physical Adverse Events Assessed by the UKU Side Effect Rating Scale [Safety and Tolerability]

  Solicited/Unsolicited Physical Adverse Events

  From the titration phase (Week 1) to the safety visit (Week 9)

Other Outcomes (4)

• Change From Baseline in Aggression Assessed by Aberrant Behavioral Checklist-Irritability Subscale (ABC-I) at Week 6

  Baseline; Week 6

• Change From Baseline in Aggression Assessed by Modified Overt Aggression Scale (MOAS) at Week 6

  Baseline; Week 6

• Change From Baseline in Clinician Global Impressions - Severity (CGI-S) Score at Week 6

  Baseline; Week 6

Study Arms (1)

Open Label

EXPERIMENTAL

Titration: Nabilone p.o., increased in 0.25 mg increments every 2 days to a maximum of 1 mg b.i.d. Open label: Nabilone p.o. at maximum dose tolerated for 28 days Tapering: Nabilone p.o. decreased in 0.25 decrements per day

Drug: Nabilone

Interventions

Nabilone DRUG

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

Also known as: 02392925 Teva-Nabilone 0.25 mg Capsule; 02384892 Teva-Nabilone 1 mg Capsule

Open Label

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of any sex or gender, race or ethnicity meeting all criteria listed below will be included in the study:
• Aged ≥25 years, as medical cannabis should not be used in any person aged \<25 as suggested by Health Canada.
• Adults with a DSM-5 diagnosis of ID meeting: a. Full scale IQ \<70 on a standardized cognitive assessment reported in their prior medical record; b. A deficit in adaptive function in at least one activity of life, as estimated by the Adaptive Behavior Assessment System, rated by the caregiver. For those whose verified records are not available, they are deemed eligible if they are connected with Disability Services Ontario. People with ID and other developmental disabilities, e.g., autism, Down syndrome, genetic conditions such as Angelman syndrome, fragile X syndrome, Prader-Willi Syndrome, etc., will also be enrolled.
• SBP, including aggressive, disruptive, and/or self-injurious behaviours in any situation (home, day program, clinic, etc.), defined as a score ≥18 on the Aberrant Behaviour Checklist-Irritability subscale (ABC-I), and a score ≥4 on the Clinical Global Impressions-Severity scale. A consistent pattern of frequent SBP should occur for \>3 months ≥1 time per week.
• Sexually active women of child-bearing potential must have a negative urine pregnancy test at the screening visit.
• Sexually active women of child-bearing must use an effective method of birth control at least from the start of last two normal menses before the screening visit to one month after the end of the study (completion of the safety visit). The accepted methods of contraception include total sexual abstinence, if it is the usual and preferred lifestyle, or consistently and correctly taking the oral hormonal contraceptive.
• Adults who receive a blood test in recent 12 months, which shows liver function test with the ALT ≤3 times the upper limit of normal and bilirubin ≤2 times the upper limit of normal.
• At least one month that needs to pass from the participation in another investigational drug trial to a given adults being allowed to participate in this trial.

You may not qualify if:

• History of hypersensitivity to any cannabinoid.
• The presence of an unstable seizure disorder as defined by having not been seizure-free for at least 3 months or anticonvulsant treatment has not been stable for at least 4 weeks.
• The presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, kidney, pulmonary disease, presence of known congenital brain malformation, as per investigator assessment based on medical history and chart review.
• The presence of a lifetime diagnosis of psychotic disorders, bipolar disorder, or substance use disorder, or current diagnosis of major depressive disorder or dementia, based on past psychiatric history noted in the medical chart, as well as Moss-PAS (ID) at S-V.
• Family history of psychotic disorders.
• Change in psychotropic medications less than 4 weeks prior to study drug use.
• At the time of screening, each adult's medication list will be checked for drugs that are known to cause interactions with nabilone. When a given adult is taking any drugs or is taking a given medication exceeding a given dose) in the following list, he/she/they will be excluded.
• Currently on benzodiazepines at the dose more than the benzodiazepine equivalent to lorazepam 2 mg daily.
• Currently on medical psychostimulant, including methylphenidate (100 mg daily), lisdexamfetamine (70 mg daily), amphetamine/dextroamphetamine (Adderall XR®, 50 mg daily), dextroamphetamine (Dexedrine®, 50 mg daily) at the dose exceeding their respective maximum doses (as shown in the bracket after each agent) to treat ADHD in adults, based on the CADDRA guideline, www.caddra.ca.
• Currently on nonbenzodiazepine hypnotics, including zaleplon (10 mg daily), zolpidem (10 mg daily), and zopiclone (7.5 mg daily), at the dose exceeding their respective suggested safety doses (as shown in the bracket after each agent), based on Canadian Recalls and Safety Alerts (https://healthycanadians.gc.ca/recall-alert-rappel-avis/).
• Currently on any opioids.
• Currently on barbiturates.
• Drinking any alcohol one week before the screening visit.
• Recreational use of any psychomimetic drugs, including Ketamine, LSD, MDMA, Magic mushrooms, PCP, Salvia, GHB, Bath salts, Methamphetamine; the last use happens within one week before the screening visit.
• Adults currently taking other cannabinoids, such as CBD or medical cannabis, from another source, unless participants and/or their caregivers are willing to stop this treatment for at least 4 weeks prior to entering the study.

Sponsors & Collaborators

• Hsiang-Yuan Lin: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Intellectual Disability; Developmental Disabilities; Aggression; Mental Disorders

Interventions

nabilone; Capsules

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hsiang-Yuan Lin, MD

  Centre for Addiction and Mental Health, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinician-Scientist

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 10, 2022
• Study Start: March 17, 2022
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)