JERUSALEM -- Adi Aran knows why families are willing to drive hours to see him.
"I believe they come to me because nothing else is working," said the Israeli doctor. "We are giving them hope. Yes, I think it's the hope."
The hope Aran is talking about comes in a 10 milliliter bottle. It is cannabis oil -- also known as CBD oil -- and Aran says it has a profound impact on many of his pediatric patients diagnosed with autism.
"Some of the families say to me it's changed their life totally," he told 13 Investigates. "And I've seen that. It changes their lives."
Aran, who oversees the neuropediatric unit at Shaare Zedek Medical Center in Jerusalem, has spent years studying the affects of CBD oil on children who have autism. His latest study -- the largest and most comprehensive of its kind in the world -- will be complete within the next few weeks. While the research is taking place half way around the globe, the impact could eventually be felt by thousands of families dealing with autism in Indiana and across the United States.
13 Investigates traveled to Israel to learn more about the groundbreaking research and what it could mean for young patients.
Nothing to lose
The idea of treating autism with cannabis oil was not Aran's idea; it came from his patients. The tall, gray-haired doctor admits his first response was skepticism.
"My initial reaction was, 'No.' There were no human studies or clinical studies .... and we didn't have any evidence that it will work," he said.
But Aran, who treats some of the most challenging cases of pediatric autism in the Middle East, eventually changed his mind. Desperate pleas from parents who lived in fear of their children's unpredictable, uncontrollable and often violent autistic outbursts convinced him to take a chance on an unproven therapy.
"We said, 'OK, we can't go on like that anymore.' We had nothing to lose, so we tried something new," Aran explained. He got permission from Israel's Ministry of Health to provide CBD oil to some of his patients, and he quickly noticed dramatic results.
"Many of them, the kids were really calm. For the first time, they were calm. The parents can get out of the house with them, and before they couldn't," the doctor said. "I saw the kids before the treatment and after the treatment, and I was very happy to see what happened."
Aran carefully documented what he observed in the first 60 children he treated with CBD oil. Behavioral outbursts were "much improved" or "very much improved" in more than 60% of the patients. Their parents reported fewer disruptive behaviors, reduced anxiety and a decrease in communication problems while their kids were taking cannabis oil. And the treatment resulted in very few negative side effects compared to the antipsychotic medications commonly prescribed to children diagnosed with autism. The results, published earlier this year in the medical journal Neurology, attracted worldwide attention.
But Aran's retrospective study was not the type of carefully-controlled scientific research that medical professionals and government agencies rely on to approve a new medical treatment -- especially a controversial treatment involving a plant that is considered illegal in many parts of the world. Cannabis is largely synonymous with marijuana, and even though most CBD oil comes from a type of cannabis plant that has very low levels THC (the psychoactive compound in marijuana that causes a "high"), it is still tightly controlled in Israel. A larger, more detailed study would be required to determine if CBD oil is considered an effective treatment for the symptoms of autism.
Inspired by his early success, the health ministry quickly granted permission for a large-scale medical trial that Aran launched in January 2017. Families living with the devastating effects of autism have been making their way to his Jerusalem office ever since, looking for hope and possible answers for their children.
Miracle for autism?
One of those children is Noam Heifetz from Tel Aviv.
The 8-year-old boy sang softly as he stepped off an elevator at the sprawling Shaare Zedek medical complex, tightly holding his mother's wrist with both hands. Noam's eyes moved quickly, scanning unfamiliar faces as he walked towards Aran's office. Once inside, he approached the doctor to examine his black wristwatch. He then walked to a window to look outside before lying down on the floor near Aran's desk.
Noam was diagnosed with autism at age two. His symptoms are severe. Noam does not speak and needs adult supervision during every waking moment.
"You have a son like that who is basically so helpless and totally dependent on you, and then the enormous tantrums, enormous anger periods, it is very difficult," explained Eyal Heifetz, Noam's father.
For years, Noam's autism has meant daily meltdowns that last for hours, with nonstop shouting and aggression. During the meltdowns, his parents say Noam tries to slam his head into walls and will attempt to shove objects into his ears. That all changed when he started taking CBD oil during Aran's medical trial.
"That ended completely and that was amazing," his father told WTHR. "We tried other medicines and it didn't affect him. It didn't stop [the autistic outbursts]. The cannabis [oil] stopped it and that, for us, was almost a miracle."
Aran shares the family's excitement, but he says not all children treated with CBD oil showed improvements, and he cautions against the idea that cannabis oil is a "miracle" for those with autism.
"I am getting desperate calls from parents every day, and I have to explain this is not a miracle treatment for autism. It's not a cure. The children remain autistic, but the quality of life is improved. Often it improved -- sometimes a lot," he said.
What is CBD oil
CBD or cannabidiol is extracted from the flowers and buds of hemp plants. Some studies have shown CBD can help reduce pain, inflammation, seizures, anxiety and other medical disorders, prompting calls for more scientific research. CBD oil does not produce intoxication because it contains very low levels of the chemical tetrahydrocannabinol (THC). The FDA does not regulate the manufacturing of CBD oil, so products can vary widely in quality and potency.
How the study works
The 2-year study now taking place in Jerusalem includes 150 children and young adults who have mild to severe autism. They receive cannabis oil that consists of 20 parts CBD (a non-psychoactive element of the cannabis plant that has anti-inflammatory and soothing properties) and one part THC dissolved in olive oil. That amount of THC can heighten the impact of the CBD but is far too small to cause a "high," according to Aran.
Noam and other participants in the clinical trial took cannabis oil three times a day for 12 weeks during one phase of the study, followed by a 4-week washout period. During a second 12-week phase, they received a placebo consisting of favored olive oil with no CBD. Because the study is a randomized, double-blind clinical trial meant to ensure scientific accuracy, families and Aran were not told whether each study participant received the CBD oil in phase one or in phase two.
For the Heifetz family, the two phases could not have been more different.
Speaking of the first phase of the trial -- when he believes his son received the cannabis oil -- Noam's father got tears in his eyes. "It was a whole different world for us. For the first time since he was very small, it was like he was free to be himself. He was calm and it's wonderful," he said.
During the second 12-week phase, Noam's more relaxed demeanor disappeared and his violent, autism-fueled tantrums returned. Once the second phase ended, the Heifetz family put Noam on a steady treatment of cannabis oil, and he quickly returned to a calm disposition with no daily outbursts or violent behavior.
"We did see a difference. A big difference," said Noam's mother, Esther.
"Life, it was quite impossible without the cannabis, and it is doable with the cannabis," her husband added. "It works. Absolutely. No doubt. I'm certain about that."
The study could provide important confirmation for Noam and others who believe cannabis oil is effective in treating symptoms of autism, and that confirmation could come very soon. As the study nears its conclusion, the double-blind portion of the trial will be lifted November 1. That's when Aran will learn when each patient received CBD oil and when each received a placebo. Data and clinical notes will then be reviewed, and study results could be released by early 2019.
Aran knows those results could dramatically change autism treatment in Israel. The Ministry of Health will use the clinical trial to determine whether autism will be added to its official Green Book, a document that details all of the legally-acceptable indications for medical cannabis in Israel. Aran says he has also been contacted by public health officials in other countries -- including the United States -- who are closely watching his study and eagerly awaiting the results.
"We know a placebo affect is real with autism [treatments]. I do not think this is just a placebo, but we will know soon," Aran told WTHR last month. "A lot of people are waiting. I am hoping [the study] could give us another tool in our toolbox to help when other medications do not."
Impact on Indiana
Hoosier families living with the effects of autism are hopeful that Aran's research will give them a new treatment tool, too.
13-year-old Kamden Hiquet was diagnosed with autism more than a decade ago. Articulate and well-mannered, Kamden seems like a typical teenager. But autism causes him to feel constant anxiety, which can be debilitating when Kamden finds himself surrounded by too many people, loud noise or stressful situations.
Currently, his most effective therapy is in the basement of the Hiquet's Columbus home: more than 100 clocks -- many of them antiques -- that Kamden has turned into a clock museum and workshop.
"The ticking helps a lot," Kamden told WTHR. "It's actually very soothing. Makes me feel concentrated. I just like the sound of it."
"Something about those clocks make him feel better," explained Kamden's mother, Nancy, who quit her teaching career to care for her son's special needs. "I don't know what it is, but that's what makes him happy and content, and that's important because every day is a struggle for him. Every day."
Even with the soothing sound of ticking and chimes, Kamden still needs medication every day to help control his anxiety. His parents worry about the side affects.
"We're not big medicine people," said Barry Hiquet, Kamden's father.
"Yeah, we put him on a low dose of something just to take the edge off, but I don't like it," added Nancy.
The Hiquets are constantly looking for new options, and have recently started investigating the possibility of CBD oil.
Earlier this year, following months of investigation by Eyewitness News, Indiana lawmakers legalized cannabis oil that contains up to 0.3% THC. Since then, some Indiana families have been experimenting with CBD oil to see if it helps to improve their children's autism symptoms. But the CBD oil showing so much promise in Israel contains 1% THC -- about three times the amount considered legal in Indiana. That amount is still much too low to cause psychoactive impact, according to Aran, but is banned under state law.
"That's just ridiculous. Makes no sense at all," said Rep. Jim Lucas (R - Seymour). "To me, it's unconscionable and criminal that we are not allowing that here in this state."
Lucas, an avid supporter of CBD oil and medical marijuana, is angry that Indiana kids who have autism cannot benefit from the type of cannabis oil that is currently being studied in Israel. The state lawmaker plans to introduce legislation in January to change that, and he believes Aran's research can help his efforts.
"Studies like that are huge. They help to educate and counteract ignorance," he said. "We don't criminalize something that we see working in other states and other parts of the world. We don't put up walls and say, 'No, you can't do that here.' We have to welcome that."
The Hiquets agree. They would like a clinically-tested, medically-proven CBD oil for autism treatment to be available to families in the United States so Kamden can use it under the supervision of a doctor.
"If it could help my son daily to overcome the challenges of autism, why wouldn't we try it?" said Kamden's mom.