Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities (NCT05273320) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities
Canada20 participantsStarted 2022-03-17
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Physical Adverse Events Assessed by the UKU Side Effect Rating Scale [Safety and Tolerability]
Timeframe: From the titration phase (Week 1) to the safety visit (Week 9)
. 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.
Exclusion criteria
. 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.