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Cannabinoids for Behavioral Problems in Children With ASD (CBA)

Disruptive behaviors are very common in children and youth with autism spectrum disorder (ASD). Behavioral problems increase social impairment in children with ASD, make interventions more difficult and place considerable strain on families and caregivers. Current treatment is based on behavioral interventions combined with atypical antipsychotics which often have low tolerability and questionable efficacy.

Cannabis exerts profound effects on human social behavior. Research using animal models of ASD indicate a possible dysregulation of the endocannabinoid system, and stress that it may be a novel target for pharmacological interventions. Anecdotal evidence suggest efficacy of various phytocannabinoids in resistant behavioral problems. However controlled human studies are lacking.

Objective: To assess the safety, tolerability and efficacy of cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel] for behavioral problems in children and youth with ASD.

Setting: A double blind randomized placebo-controlled trial with crossover.

Methods: One hundred and fifty participants, ages 5-21 years, with ASD and moderate to severe refractory behavioral problems will be randomized to receive 1 out of 3 treatments for 12-weeks and cross-over to another treatment in a second 12 weeks period. Treatment options are: (1) oral placebo (2) cannabis extract, contains cannabidiol and Δ9-tetrahydrocannabinol in a 20:1 ratio, at a cannabidiol dose of 10 mg/kg/d and (3) pure cannabidiol and Δ9-tetrahydrocannabinol in the same ratio and dose.

Outcomes and measures: Two co-primary endpoints will compare the whole plant extract treatment to the placebo treatment on a within subject design. 1) The change from baseline Home Situations Questionnaire-ASD score after 3 months of treatment (HSQ-ASD; a parent rated assessment of disruptive behavior). 2) The Clinical Global Impression- improvement (CGI-I; a clinician rated assessment of improvement in disruptive behavior following treatment)

Secondary efficacy outcomes include:

  • Within subject differences between the placebo condition and the pure cannabinoids condition and between the whole plant extract condition and the pure cannabinoids condition in the change from baseline HSQ-ASD score after 3 months of treatment and in the CGI-I.
  • Within subject differences between each pair of the 3 conditions in the Clinical Global Impression- drug effect (CGI-D).
  • Within subject differences between each pair of the 3 conditions in the change from baseline after 3 months of treatment in: Social Responsiveness Scale (SRS) parent and teacher rated, Child Behavior Checklist (CBCL) and autism parenting stress index (APSI).

Safety endpoints will include the proportion of patients with adverse events measured by the investigators and the Liverpool Adverse Events Profile (modified).

Exploratory measures are: markers of the endocannabinoid system in the patients’ blood and possible correlation to phytocannabinoids bioavailability and treatment response, change from baseline at the end of treatment in BMI and Children’s Sleep Habits Questionnaire (CSHQ) score and quality of parent- child interaction during the study (Emotional Availability- EA).

Long term safety, tolerability and efficacy of cannabidiol-rich medical cannabis will be assessed after 12 and 24 months of open treatment, in a subgroup of patients who will apply for medical license to use cannabis after completing the study.

Medical Cannabis and Children With Autism

A recent study conducted by Israeli researchers found that medical cannabis is an effective therapy for children on the autism spectrum. The results, to be published in the Journal of Neurology, document how conditions improved for 80 percent of the autistic children treated with high concentrations of CBD. Conversely, those children who were treated with traditional therapies showed no improvement.

Adi Aran, M.D., Director of Pediatric Neurology at Jerusalem’s Shaare Zedek Hospital, treated the children with a high-CBD cannabis oil (20% CBD and 1% THC) for at least seven months. He then asked the parents to respond to questions he presented regarding behavioral changes they observed in their children, including their anxiety levels and ability to communicate. Fifty percent of the parents said their children experienced improved communication; 80 percent reported decreased problematic behaviors; and 40 percent reported significant decreases in anxiety.

The prevalence of autism is increasing. The Centers for Disease Control (CDC) estimates that 1 in 59 children have autism. This disorder typically appears in early childhood and lasts a lifetime. Symptoms range from compulsive, repetitive behaviors, to impaired socialization and communication skills, while some children cannot speak at all. Many children on the spectrum experience problems with agitation and irritability. Doctors typically treat these symptoms with antipsychotic medications, which have a number of harmful side effects, limiting their use.

The frequency of epilepsy in people with autism is much higher than that of the general population. Dr. Thomas Deuel, a neurologist with the Swedish Hospital in Seattle, who has been studying the relationships between autism and epilepsy along with other scientists, suspects that the different brain development that occurs in autistic children is more likely to create circuits that cause epileptic seizures. Many parents who have learned about Dr. Deuel’s study have approached him regarding treatment for their autistic children. However, very few studies have been conducted up to this point due to skepticism from many in the medical field regarding the benefits of CBD.

One of the biggest impacts to encourage future research has been the U.S. Food and Administration’s (FDA) approval of Epidiolex, a CBD oil-based elixir manufactured by British drug developer GW Pharmaceuticals, as a treatment for two rare types of childhood epilepsy. FDA scientists approved Epidiolex because they were convinced by the overwhelming body of evidence presented to them by GW Pharmaceuticals regarding the drug’s positive effects.

Dr. Orrin Devinsky, a neurologist with New York University who conducted the research on Epidiolex, is now conducting two studies on CBD’s effects on children ages 5 to 18 with moderate to severe autism. Since autism and epilepsy go hand in hand, scientists believe that CBD shows promise for treating both conditions.

Geoffrey Brown, PharmD is a pharmacist at MedMen medical marijuana dispensary who has conducted neuroscience research in behavioral health.