Israel is pioneering the first cannabis autism trial of its kind in the world. Times of Israel looked into the trial consisting of 120 children and young adults with severe autism being treated with cannabinoids.
Dr. Adi Aran, director of Jerusalem’s Shaare Zedek Medical Center, neuropediatric unit, said the study has come into existence because of the progressive stance Israel is taking on cannabis research. The scientific community and the families of children with autism have expressed a keen interest in the trial.
Parents have hope again
Dr. Aran says families came from all over Israel hoping to be able to participate in the study. Unfortunately, the list is full. Autism affects roughly one percent of the population worldwide and is a neurodevelopmental disorder. The diagnosis usually comes in infancy or early childhood. Autism affects communication skills. It can cause impaired and compulsive and repetitive behavior, and often, patients self-harm. The disorder is not well understood, and there is no cure.
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Cannabis, autism, and seizure disorders
Many children with autism are treated with anti-psychotic medication. It often has no effect but has severe side effects. Parents and doctors want a safer and more effective way to help people with autism, and they’re hoping cannabis is the answer.
Dr. Aran previously investigated cannabis extracts, administering them to 70 young autistic patients with positive results. It also helped to suppress epilepsy. Almost 20% of autistic children suffer seizures from epilepsy. Research showed that cannabis extracts brought some relief to participant’s symptoms specific to their autism.
Lack of scientific evidence made it difficult to move forward. Many physicians are in this situation where patients are asking for cannabis. But there is no scientific evidence, to support its use. Aran was amazed at how easy it was to get approval for this study.
Health Ministry is pro-active
Dr. Tamir Gedo, CEO of the company providing the cannabis extracts for the study, said the Israeli government’s Health Ministry is progressive and scientific in their approach, making the study possible. In other countries, getting ethical and regulatory approval would have been extremely difficult.
Gedo said Israel is in the fortunate position to have clinicians and scientists open to cannabis as a medicine. Furthermore, there is a strong biotech industry supported by researchers from top universities and medical institutes.
Consistent chemical profile
Gedo explained it is crucial to have consistent levels of the cannabinoids THC and CBD in medicine to be able to provide the FDA with data that is acceptable. Scientific medicine requires specific dosage protocols and a consistent chemical profile. In Israel, there are more than 100 different strains of cannabis. Worldwide, there are thousands.
CBD and THC
Participants in the cannabis autism trial will receive pure CBD and THC in a 20:1 ratio. The synergetic effect of other cannabinoids in cannabis is not yet fully understood. So far, scientists have identified 140 identified cannabinoids. In theory, different cannabinoids help each other do their work, but we don’t yet know how they interact.
Design of the study meets highest standards
The patients participating in the cannabis autism study will receive cannabis compounds or a placebo over a 12 week period. They will then go without for four weeks before receiving treatment or a placebo for a further 12 weeks. Those participating are aged between 5 and 29 years old. More than 40% don’t respond well to medication. Patients will be evaluated before the start of the study, after the first 12 weeks and again after the next 12 weeks.
Caregivers and teachers will also be asked to report on patients. It is a double-blind study and this will give the results a high degree of credibility. In other words, neither the researchers nor the patients know which mixtures the subjects are taking. Thirteen participants are already on a treatment.