Israel conducts first clinical trial in children with autism

A research team from the Neuropediatrics Unit of the Shaare Zedek Medical Center in Jerusalem, led by physician and researcher Adi Aran, is testing, for the first time in the world, the effects of cannabinoids on children and young people with severe cases of autism and the first results are proving to be very promising, recently reported the USA Today. The study involves 120 children and young adults between the ages of 5 and 29 with medium to high severity autism cases. Contacted by email, the researcher confirmed to Cannapress that “the study is ongoing and we will not have final results before the end of 2018. I will be happy to discuss the study with Cannapress once we have results”.

Neuropediatrician Adi Aran, photographed by Tomer Appelbaum for the Israeli newspaper Haaretz

Adi Aran has never tried cannabis and until recently was very skeptical of its benefits. “Many parents asked for cannabis for their children. At first I said, 'No, there are no data to support the use of cannabis for autism, so I can't administer it.'” says the researcher. But his view changed about a year ago, after some studies in Israel showed that cannabis helped children with epilepsy, dramatically reducing seizures and even improving the behavior of those who, in addition to epilepsy, also had autism. "Epilepsy affects about 20 to 30% of autistic children," explained Aran. Parental requests and accumulating evidence of autistic children who improved on cannabis led Adi Aran to test cannabis on 70 of his patients in an observational study. After getting some positive results he went ahead with the world's first clinical trial: "We need to do a clinical trial so we can have data," he decided.

But not everything was a bed of roses. Despite interest from families and the medical community, the lack of scientific evidence was the main obstacle to moving forward with the study, Adi Aran told The Times of Israel. “The dilemma was not just our dilemma. Many doctors and researchers around the world are in the same position: families ask because they heard about it or researched it on the internet, but there are no studies that prove the safety and effectiveness of the treatment”.

Adi Aran confirmed that nearly all of the participants in this study had previously been treated with antipsychotics, the only drugs that are commonly prescribed to children with autism, and that about half reacted negatively, manifesting various adverse side effects. There are now empirical evidence that the main non-psychoactive compound in cannabis, cannabidiol (CBD), helps children more effectively than any other medication and without any side effects. This pioneering study aims to determine the veracity of this hypothesis.

Yael Shulman with daughter Noah, who participates in the first clinical trial to test the benefits of medical cannabis in children with autism (Photo: Yardena Schwartz, USA TODAY)

The trial began in January 2017 and 120 participants are given either liquid drops of cannabis oil or a placebo. “Our waiting lists are full. Many families want to participate and come from all over Israel,” the investigator continued. "They're hopeful because they've heard from friends and other families that it might work."

Aran cautioned, however, against jumping to conclusions about cannabis as a treatment for autism, but said many children showed significant improvements. “Some are no longer self-harming or temper tantrums, others have become more communicative and others have been able to return to classes after suspensions for behavioral problems,” he confirmed.

Tamir Gedo, CEO of Breath of Life Pharma, which provides cannabis oil for this study, told USA Today that a mother told her the following: “My son talks nonstop, and he never has! He is 12 years old.”

One of the biggest concerns, however, is the long-term impact of administering cannabis to children and youth, said Sarah Spence, co-director of the Autism Spectrum Center at Children's Hospital Boston. "It is true that there may be danger to brain development," she said. But on the other hand, “opiates and antipsychotic drugs currently prescribed to children are more dangerous. This is the only hope for the families!”, concluded Tamir Gedo.

Autism is a neurological disorder that tends to manifest gradually in childhood and persists through adolescence and adulthood. The disorders are essentially revealed in the difficulties of communication, social interaction and repetitive behaviors or restricted interests, varying in intensity according to the cases and the evolution of the disease. According to recent data from World Health Organization, autism spectrum disorders affect one in 160 children worldwide, but according to the US Centers for Disease Control and Prevention, autism affects one in 68 children in the US.

Israel was one of the first countries in the world to allow the use of medical cannabis, in 1992, and is a pioneer in research and studies on cannabis as a medical treatment. There are currently more than 110 clinical studies on cannabis underway in Israel, making this country the world leader in the field. It should be noted that two of the three medicinal cannabis plantations already authorized in Portugal are managed by Israeli companies.
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(Featured image: Luke Tress, The Times of Israel)