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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

Must not have

Sexually active women of child-bearing potential intending to breastfeed or get pregnant

Currently on benzodiazepines exceeding equivalent to lorazepam 2 mg daily

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the titration phase (week 1) to the safety visit (week 9)

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My recent liver tests are within the required limits.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman who could get pregnant and plan to breastfeed or try for a baby.

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I am taking more than 2 mg of lorazepam or its equivalent daily.

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I am currently taking opioids or barbiturates.

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My seizures are not under control.

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I am taking medications that interact with nabilone.

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I am taking higher doses of ADHD medication than usually prescribed.

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I do not have any serious or unstable health issues.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the titration phase (week 1) to the safety visit (week 9) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Other study objectives

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 more

Awards & Highlights

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.

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

0 / 10Eligibility criteria met