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Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities (N-AND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05273320
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
Hsiang-Yuan Lin, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Intellectual Disability Developmental Disability Aggression Behavior Problem Drug: Nabilone Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Pre-pilot Open-label Clinical Trial of Nabilone for Severe Behavioural Problems (Aggression) in Adults With Intellectual and Developmental Disabilities
Actual Study Start Date : March 17, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024


Arm Intervention/treatment
Experimental: Open Label

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
Nabilone capsules at a maximum dose of 1 mg twice a day
Other Name: 02392925 Teva-Nabilone 0.25 mg Capsule; 02384892 Teva-Nabilone 1 mg Capsule




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Physical Adverse Events Assessed by the UKU Side Effect Rating Scale [Safety and Tolerability] [ Time Frame: From the titration phase (Week 1) to the safety visit (Week 9) ]
    Solicited/Unsolicited Physical Adverse Events


Other Outcome Measures:
  1. Change From Baseline in Aggression Assessed by Aberrant Behavioral Checklist-Irritability Subscale (ABC-I) at Week 6 [ Time Frame: Baseline; Week 6 ]
    Aberrant Behavioral Checklist-Irritability subscale (ABC-I): The ABC is a 58-item rating scale completed by a caregiver. It consists of 5 subscales. Among them, the Irritability subscale consists of 15 items.

  2. Change From Baseline in Aggression Assessed by Modified Overt Aggression Scale (MOAS) at Week 6 [ Time Frame: Baseline; Week 6 ]
    Modified Overt Aggression Scale (MOAS) is a reliable measure used to measure behavioural problems in adults with IDD. It consisted of 4 items and is administered by the researcher's interview with the caregiver.

  3. Change From Baseline in Clinician Global Impressions - Severity (CGI-S) Score at Week 6 [ Time Frame: Baseline; Week 6 ]
    CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment relative to the clinician's experience with participants who had the same diagnosis. This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill.

  4. Clinical Global Impressions - Improvement (CGI-I) Score at Week 6 [ Time Frame: Baseline; Week 6 ]
    CGI-I is a 7-point scale that requires the clinician to assess how much a participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention. This is rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 6 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273320


Contacts
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Contact: Research Analyst 416-535-8501 ext 37832 n-and@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Research Analyst    4165358501 ext 37832    n-and@camh.ca   
Principal Investigator: Hsiang-Yuan Lin, MD         
Sponsors and Collaborators
Hsiang-Yuan Lin
Investigators
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Principal Investigator: Hsiang-Yuan Lin, MD Centre for Addiction and Mental Health, Toronto, Ontario, Canada
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Responsible Party: Hsiang-Yuan Lin, Clinician-Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT05273320    
Other Study ID Numbers: 135-2020
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hsiang-Yuan Lin, Centre for Addiction and Mental Health:
Intellectual Disability
Developmental Disability
Aggression
Behavior Problem
Additional relevant MeSH terms:
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Intellectual Disability
Aggression
Developmental Disabilities
Problem Behavior
Neurologic Manifestations
Nervous System Diseases
Behavioral Symptoms
Neurobehavioral Manifestations
Neurodevelopmental Disorders
Mental Disorders
Dronabinol
Nabilone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hallucinogens
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones