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Synthetic Cannabinoid
Nabilone for Aggression in Intellectual Disabilities (N-AND Trial)
Phase 1
Recruiting
Led By Hsiang-Yuan Lin, MD
Research Sponsored by Hsiang-Yuan Lin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults with recent liver function test showing ALT ≤3 times the upper limit of normal and bilirubin ≤2 times the upper limit of normal
Participants aged ≥25 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the titration phase (week 1) to the safety visit (week 9)
Awards & highlights
N-AND Trial Summary
This trial will test whether a synthetic cannabinoid is a safe and tolerable alternative to treat severe behavioural problems in adults with intellectual and developmental disabilities.
Who is the study for?
Adults over 25 with intellectual and developmental disabilities (IDD) like autism or Down syndrome, who show severe behavioral problems. They must not have used other cannabinoids recently, be free from certain medical conditions, and women of childbearing age need a negative pregnancy test and must use birth control.Check my eligibility
What is being tested?
The trial is testing Nabilone, a synthetic cannabinoid, to see if it's safe and can help manage aggression in adults with IDD. It's an open-label study where everyone gets the drug to assess changes in behavior before and after treatment.See study design
What are the potential side effects?
Potential side effects of Nabilone may include drowsiness, dry mouth, dizziness, euphoria (feeling 'high'), ataxia (loss of full control of body movements), headache, disorientation or confusion.
N-AND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent liver tests are within the required limits.
Select...
I am 25 years old or older.
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I am a woman who can have children and my pregnancy test is negative.
N-AND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the titration phase (week 1) to the safety visit (week 9)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the titration phase (week 1) to the safety visit (week 9)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Physical Adverse Events Assessed by the UKU Side Effect Rating Scale [Safety and Tolerability]
Other outcome measures
Change From Baseline in Aggression Assessed by Aberrant Behavioral Checklist-Irritability Subscale (ABC-I) at Week 6
Change From Baseline in Aggression Assessed by Modified Overt Aggression Scale (MOAS) at Week 6
Change From Baseline in Clinician Global Impressions - Severity (CGI-S) Score at Week 6
+1 moreN-AND Trial Design
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nabilone
FDA approved
Find a Location
Who is running the clinical trial?
Hsiang-Yuan LinLead Sponsor
Hsiang-Yuan Lin, MDPrincipal InvestigatorCentre for Addiction and Mental Health, Toronto, Ontario, Canada
2 Previous Clinical Trials
170 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent liver tests are within the required limits.I am a woman who could get pregnant and plan to breastfeed or try for a baby.I haven't changed my mental health medications in the last 4 weeks.I am a woman who can have children and I use effective birth control.I am willing to stop taking cannabinoids 4 weeks before the study starts.I am taking more than 2 mg of lorazepam or its equivalent daily.I am currently taking opioids or barbiturates.My seizures are not under control.I am taking medications that interact with nabilone.I am taking higher doses of ADHD medication than usually prescribed.I do not have any serious or unstable health issues.I am 25 years old or older.I am a woman who can have children and my pregnancy test is negative.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many experimental subjects are in this research?
"That is accurate. The clinical trial is recruiting patients and was most recently updated on 3/21/2022. The study is looking for 30 patients from 1 location."
Answered by AI
What are the associated risks of taking Nabilone?
"Because Nabilone is only in Phase 1 of clinical trials, there is limited data to support its safety and efficacy. However, our team still gave it a 1."
Answered by AI
Are investigators still looking for participants for this study?
"That is correct, according to the clinicaltrials.gov listing, this research is currently looking for subjects. The posting went up on 3/17/2022 and was last edited 3/21/2022. They are enrolling 30 individuals at a single location."
Answered by AI
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