Using Nabilone to Treat Aggression in Adults with Intellectual Disabilities

Phase I Pre-pilot Open-label Clinical Trial of Nabilone for Severe Behavioural Problems (Aggression) in Adults With Intellectual and Developmental Disabilities

This study is testing whether nabilone can help reduce aggressive behavior in adults with intellectual disabilities.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Centre for Addiction and Mental Health (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05273320 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of nabilone, a synthetic cannabinoid, in adults with intellectual and developmental disabilities who exhibit severe behavioral problems. The study involves a screening visit to assess eligibility, followed by a baseline visit, a dose titration phase, and a 4-week open-label treatment phase. Participants will be monitored for changes in aggressive behaviors and overall safety throughout the trial. This is the first study of its kind to explore the effects of nabilone in this population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 25 and older with a DSM-5 diagnosis of intellectual disability and severe behavioral problems.

Not a fit: Patients under 25 years of age or those without a diagnosis of intellectual or developmental disabilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for managing aggression in adults with intellectual and developmental disabilities.

How similar studies have performed: While there is limited rigorous evidence on the use of nabilone for this specific population, preclinical studies suggest potential efficacy, making this approach novel.

Eligibility criteria

Inclusion Criteria:

Participants of any sex or gender, race or ethnicity meeting all criteria listed below will be included in the study:

1. Aged ≥25 years, as medical cannabis should not be used in any person aged \<25 as suggested by Health Canada.
2. 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.
3. 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.
4. Sexually active women of child-bearing potential must have a negative urine pregnancy test at the screening visit.
5. 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.
6. 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.
7. 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:

1. History of hypersensitivity to any cannabinoid.
2. 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.
3. 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.
4. 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.
5. Family history of psychotic disorders.
6. Change in psychotropic medications less than 4 weeks prior to study drug use.
7. 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.

   1. Currently on benzodiazepines at the dose more than the benzodiazepine equivalent to lorazepam 2 mg daily.
   2. 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.
   3. 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/).
   4. Currently on any opioids.
   5. Currently on barbiturates.
   6. Drinking any alcohol one week before the screening visit.
   7. 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.
8. 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.
9. Adults who might travel out of the area for a significant time during the study.
10. Adults who recently are participating in another investigational drug trial.
11. Pregnancy.
12. Sexually active women of child-bearing potential intended to give breastfeeding or to get pregnant.

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Hsiang-Yuan Lin, MD — Centre for Addiction and Mental Health, Toronto, Ontario, Canada
• Study coordinator: Research Analyst

Conditions Intellectual Disability; Developmental Disability; Aggression; Behavior Problem