Evidence that cannabinoids can help improve the quality of life of autistic people has, until now, been anecdotal. Now an Israeli doctor is launching a formal clinical trial of “medical cannabis” among autistic children and teenagers – the first of its type.
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Dr. Adi Eran, who is heading up the endeavor, is in the process of obtaining permits from the Health Ministry for the study, which will involve 120 autistic individuals, male and female, aged 4 to 30, who are defined as low to medium functioning.
As is usual when medical cannabis is administered, participants will be given cannabis oils free of the intoxicating substance but rich in cannabidiol (CBD), one of the active chemicals found in cannabis.
Eran, head of the pediatrics neurology department at Shaare Zedek Medical Center in Jerusalem, has obtained the authorization in principle from the Israel Health Ministry for his tests. He is presently working on obtaining permits and finding subjects from other local hospitals, as well as from psychiatric facilities and centers dealing with childhood development.
Per the norm in proper clinical research, participants will be divided into two groups: the test group that actually ingests the oil, and the control subjects who will be given placebos. After a test period during which the effects on the patients will be recorded, treatment will be halted for a month, then the groups will be reversed – the test group will become the control group and vice versa. Again, as is typical in such research, at no point will subjects or their families know whether the patient is receiving CBD or a placebo.
The study will focus specifically on a certain segment of behavioral symptoms typical of certain autistic individuals, including physical aggression toward themselves and others, attacks that can be accompanied by acute anxiety.
Risks and uncertainty
Drug treatment in general and use of cannabis, too, involve risks and uncertainty. Health officials also hesitate to use cannabinoids on children, even after their intoxicating qualities are neutralized. Thus, assuming it goes ahead, this study will be breaking ground here, as well.
Meanwhile, a Health Ministry subcommittee is hashing out rules concerning in the cases in which medical cannabis may be prescribed to treat autism – a process that includes defining the “severe behavioral problems” that would require use of the substance.
Presently, of course, cannabis oil is not recognized as a form of treatment for autism. Even so, Eran explains, several dozen Israelis who suffer from the disorder have received approved prescriptions for the drug because of the severity of their symptoms and behavior – mainly because nothing else helped them. The families know cannabis isn’t a recognized treatment but had nothing to lose, the specialist says, although he stresses that its merit has yet to be tested under rigorous conditions. Now it will be.
Cannabis has been making inroads in psychiatry in recent years, including in treating post-traumatic stress disorder, not that it’s easy to procure. In March 2014 cannabis was approved in treating epilepsy, including in severely affected children, whose lives have been severely impaired by the disease and no other medication seems to work. Epilepsy is extremely common among autistic people – as many as 30 percent suffer from it. It was while treating autistic epileptics that a positive effect on behavior was reportedly observed.
Part of the existing anectodal evidence in such cases comes from the Israeli medical cannabis supplier Tikun Olam, which has been providing oil to some 10 autistic people aged 8 to 22 (irrespective of the impending study). Naama Saban, a pediatric nurse, says treatment with CBD oil three times a day made the patients significantly calmer and less violent.
“It isn’t that they’re stoned because the oil has no psycho-active component,” Saban says. “Their parents say the quality of life has completely changed. That for the first time, their little kids can have friends over and the big brother doesn’t go wild.”
For their part, doctors have no intention of "going wild," until they know how the cannabinoid compound works neurologically on the brains of epileptic and autistic patients, and what its side effects and/or implications could be. Hardly any research has been done on the topic: Due to the stigma associated with the plant over decades, cannabis science is still a relatively new thing.