Does cannabidiol reduce severe behavioural problems in youth with intellectual disability? Feasibility and pilot randomised placebo-controlled trial.
Pilot study of cannabidiol (CBD) in children with Intellectual Disability (ID) and Severe Behavioural Problems (SBP)
Murdoch Children's Research Institute
10 participants
Jan 8, 2019
Interventional
Conditions
Summary
This is a single site, double-blind, parallel group, randomized, placebo-controlled pilot study of 10 participants comparing 98% cannabidiol oil (CBD) with placebo in reducing Severe Behavioural Problems (SBP) in children aged 8 – 16 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo. The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, tolerability of the study medication, study duration, study procedures and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized clinical trial of CBD to reduce SBP in children with ID. The secondary objectives of this study are to assess the safety of the administration of oral CBD in children aged 8 -16 years with ID and SBP.
Eligibility
Inclusion Criteria12
- Each patient must meet all of the following criteria to be enrolled in this study:
- Males and females aged 8 – 16 years of age;
- DSM-5 diagnosis of ID.
- a. Full scale IQ < 70 on standardized cognitive assessment on verified records of testing performed within two years of enrolment. In the event that records of prior testing are unavailable or the assessment was more than 2 years prior, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence-II.
- b. Deficit in adaptive function (basis for severity rating of ID in DSM-5) in at least one activity of life: Vineland Adaptive Behavior Scales completed by interview with the parent or guardian; derives scores in Communication, Daily Living Skills and Socialization domains, and a Global Adaptive score.
- SBP: Defined as:
- a. scores of 18 or higher on the Aberrant Behavior Checklist-Irritability subscale (ABC-I), and
- b. moderate or higher on the Clinical Global Impressions-Severity scale.
- Consistent pattern of frequent SBP symptoms for > 3 months (parent interview).
- No changes in either medication or other interventions in the 4 weeks prior to randomization.
- Written informed consent from parent or legal guardian.
- Has the ability to comply with the protocol requirements, in the opinion of the investigator.
Exclusion Criteria3
- Non-English speaking parents.
- Psychosis, bipolar disorder, major depressive disorder, obsessive compulsive disorder.
- Taking anti-epileptic medications which interact with CBD (e.g. clobazam, topiramate, zonisamide)
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Interventions
Tilray Cannabis Extract - 98% Cannabidiol in oil. Oral administration of liquid solution via dropper. 20mg/kg/day, with a ceiling dose of 1000mg/day. The starting dose of CBD or placebo will be 5 mg/kg/day and will be administered orally twice daily in doses of 2.5 mg/kg. The dose of CBD or placebo will be increased in increments of 5 mg/kg/day every 3 days for 9 days up to the maintenance dose of 20 mg/kg/day (Up Titration Phase). Participants will continue to receive CBD at the maintenance dose for 56 days (8 week Maintenance Phase). On completion of the maintenance phase the dose of CBD will be decreased in increments of 5mg/kg/day for 9 days at which time CBD administration will cease. Participants will return any unused study drug, as well as empty medicine bottles, to the trial Pharmacy, who will weigh the bottles to obtain an estimate of treatment compliance.
Locations(1)
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ACTRN12618001852246