hempworx cbd oil for autism

Everything You Need to Know About CBD Oil for Autism

If you’re a parent that has a child with autism, you might wonder if these anecdotal reports about CBD Oil are actually true. It’s hard to ignore the growing popularity of our society using CBD to treat many different conditions and symptoms. Sources like Forbes project CBD products to be a $2.2 billion dollar industry over the next 2 years.

CBD is recommended as a treatment for conditions such as seizures, depression and anxiety, and symptoms such as sleeplessness, inflammation, acne, and pain. It seems to be something that everyone could benefit from using; its effects can be so widespread.

But can CBD oil really help children and adults with autism?

What is CBD?

Cannabis plants produce thousands of compounds but the most recognized belong to a class called cannabinoids. There are several cannabinoids but the two that are most well-known among consumers are THC (tetrahydrocannabinol) and CBD (cannabidiol).

Derived from an extraction process from the flowers and buds of cannabis plants, either marijuana or hemp, CBD does not produce intoxication as it is a non-psychoactive compound, unlike marijuana’s “high” which is caused by the chemical tetrahydrocannabinol (THC).

If you are interested in or have been researching medicinal marijuana for those with autism, CBD oil could possibly be a better option. This is something you should discuss with your child’s doctor.

You may hear the term “hemp oil” when referring to CBD oil. Hemp is one of the varieties of cannabis plants that CBD is most commonly extracted from. Although in most cases CBD oil from hemp has no THC, it’s important to note that isn’t always the case. So going forward, we recommend focusing on CBD oil for those with autism.

CBD oil can be taken orally in many forms – some sources break consumption into categories – ingestible, topical, and smokeable. CBD oil can be administered in a dropper as a tincture, be encapsulated into a pill, baked into a brownie, vaped or even smoked. CBD products include edibles like gummies, beverage drinks, soaps, and creams or a transdermal patch similar to a nicotine patch.

Full Spectrum or Isolate?

Besides the type of plant CBD is extracted from, you can also choose the type of CBD you want based on how it’s processed. Full spectrum, or “whole plant” CBD, has a variety of potentially beneficial cannabinoids plus plant terpenes and flavonoids found in the original plant. CBD isolate is when all the other cannabis compounds are removed and only the CBD is left. It is not “whole plant” based and contains only one part.

It’s believed that using full-spectrum has more benefits than using CBD alone.

How do you choose which CBD oil to use?

There are so many brands of CBD oil to choose from. There are also many “snake oils” on the market, so it’s important to do your research. Find out the source of the CBD, where it’s grown and how it’s processed. You should check third-party testing results provided by CBD Oil companies.

If a company can’t provide you with a third-party lab test or a certificate of authentication (CoA), then we would recommend finding another brand.

Is CBD Legal?

In December 2018, Congress passed the 2018 Farm Bill which, if it hasn’t already, will be signed by the President.

What this means is that CBD processed from hemp, with a THC level of less than 0.3%, will be legal in all 50 states. If CBD oil has more than 0.3% THC it is considered non-hemp and has no federal legal protection at all.

And even though CBD oil from hemp is now legal, there are still strict regulations, as well as government oversight as to who can grow hemp, where it can be grown and how it’s cultivated and produced.

Click here for state by state regulations concerning cannabis products that do not fall under the protections of the 2018 Farm Bill.

Some states allow doctors to use their clinical discretion to prescribe CBD to their autistic patients. Some parents have sought out CBD separately to treat other symptoms such as pain or sleep issues, and have noted the secondary effects on the symptoms of autism. The therapeutic properties of cannabis, primarily of CBD, can help alleviate some of the negative behavioral effects of autism, such as anxiety and epileptic seizures.

Additionally, with CBD oil there are regulation issues around how much CBD vs THC are in the oil. Oral absorption is difficult to measure, and it is thought that less than 20% of the drug is absorbed when taken by mouth.

A recent study of CBD oil products found some productions had too little and others too much, and 1/5 CBD products contained THC, which can cause anxiety or make seizures worse.

As with any new treatment, it needs to be closely followed by doctors to watch for potential interactions with other meds, as well as resultant liver problems.

What is the correct dose of CBD Oil for Autism?

There is no recommended daily allowance (RDA) of CBD. Doctors may suggest a dosage to a patient, but don’t typically prescribe it due to legal issues. For doctors in training, the use of CBD oil and its benefits hasn’t been studied enough to be taught in pharmacology classes in medical school – there are no experts here.

CBD oil manufacturers often recommend a serving size on the label, but the amount of CBD is different in each product. The most common recommendation is to start small and increase as needed. Our chart will give you an idea of where to start with your child based on his or her weight.

Because every child is different, it will take time to find the best dose for your child.

How Does CBD Oil work for those with Autism?

We all have an endocannabinoid system that receives signals from cannabinoid that enters the body. When you consume CBD it enters your bloodstream, brain and nervous system almost immediately.

The endocannabinoid system moves in the opposite direction when compared to neurotransmitters. It moves up to the neurons and attaches to the cannabinoid receptors of the neuron that will send a “message”. Once there, the cannabinoids control what happens the next time the neurons activate and can effectively change what happens to the body and mind.

Endocannabinoids can help regulate hunger, anxiety, neuronal excitability, protection, and pain, among other things. With individuals with epilepsy, CBD oil can help suppress seizures. Those who look to cannabinoid medicine to help with autism believe that it can help bring order to the brain. It is well known that individuals with autism struggle with focus and attention, and cannabis can alter their spectrum of attention.

The effect of CBD oil begins at different rates for different people depending on dosage and product. Vaping/smoking can produce effects the quickest, sublingual tinctures may take 20-40 minutes, and edibles can take 1-2 hours to move through the digestive system. CBD taken topically in a cream or salve can also take an hour to get into the bloodstream, but their effects can last up to 6 hours.

Is it effective for autism andAsperger’s?

We want to know how CBD oil impacts autism. Is CBD an effective treatment for autism? Is obtaining medical marijuana for autism a good investment of time and resources? And do the benefits outweigh the risks?

There are multiple facets to consider when answering these questions. The simple answer is that there isn’t a wealth of research done for pediatric patients with autism – there is practically NO study validating the idea that cannabis is an effective and available option for the treatment of autism yet.

Nevertheless, one can’t ignore the reports of this “miracle drug” that has so many proven success stories.

For an individual with autism, a developmental disability with no proven “treatment”, you’re open to many therapies and strategies that might alleviate symptoms. CBD itself has shown promising results as a treatment for a variety of conditions, many of which are otherwise not treatable.

The most well-known properties of CBD are neuroprotective, anticonvulsant, anti-inflammatory and analgesic. CBD also possesses therapeutic value to treat conditions like depression, anxiety, and dependence.

Some reports show a decline in aggressive behavior, a significant decrease in seizures, and improved speech. Some accounts include children who did not speak before treatment who achieved significant results in a short period of time after their first dose of CBD oil.

Can we prove the benefits of CBD oil for autism?

Back in 2015, the Harvard Review and Boston Children’s Hospital put together a baseline study of cannabis research to date, which stated that most research was animal-based and did not yet show a generalized impact on human subjects.

The review concluded with the cautionary statement that cannabis treatments should be used as a last resort after all conventional therapies have failed. Indeed, a widespread reluctance exists within the pediatric community to study the effects of cannabis in children, due to the potential of harmful side effects.

There have been hundreds of studies on the effect of marijuana and different health impacts. Currently, there are two studies slated to study cannabis specific to autism – but they have not yet started. There is a risk to study children in general, and especially with a controlled substance like marijuana, which is known to damage the cells of a developing brain.

In many studies of CBD oil, there have been clinical trials done with adults, but they are not specific to children. Use of CBD oil for antipsychotic, antidepressant or sleep aid uses have been studied on animals but limited research has been to include humans.

Some published studies used case reports and retrospective accounts, but not true research with clinical trials and placebo groups. A recent retrospective study of individuals with ASD did report improvement in disruptive behavior, anxiety, and communications. Unfortunately, there were some (minimally reported) adverse effects such as sleep disturbance, irritability, and loss of appetite in participants.

A pediatric neurologist in Israel began research last year with 60 children on the autism spectrum and while still to be published, some preliminary results have been released. These qualifying study subjects had not responded to previous conventional drug therapies. 80% of participants who were treated for 7 months with 20:1 ratio of CBD to THC saw improvements. After the study, parents were asked about communication, behavior, and anxiety. 80% of parents noted a decrease in problem behavior, with 62% reporting significant improvement in behavior. Additionally, 50% noted an improvement in communication, 40% reported a decrease in anxiety (2/3 of the participants began the study with anxiety).

In 2017, there was a retrospective study conducted in Chile on 20 children who were given a CBD oil tincture orally for 3 months. The CBD to THC ratio was 1:1 – but the specific dosage wasn’t indicated. In looking at that study, one can note that this substance was not solely CBD, but equal parts CBD and THC.

The positive part of this study was that it was done with children with ASD – something that we don’t have a lot of research on. The outcome of the study was that caregivers reported improvement in at least one core symptom of autism – social communication, language, or repetitive behaviors. Additionally, sensory difficulties, food-based/texture tolerance, sleep disorders, and/or seizures improved as well.

CBD Oil for Autism and Epilepsy

Did you know that less than 2% of the general population has epilepsy, but up to 33% of people with autism also suffer from epilepsy? While scientists do not clearly understand the reasons behind the relationship, they suspect that the different brain development that occurs in autistic children is more likely to create circuits that cause epileptic seizures.

Earlier this year, a U.S. Food and Drug Administration advisory panel unanimously recommended approval of the CBD medication Epidiolex to treat two rare forms of childhood epilepsy, Dravet Syndrome and Lennox-Gastaut Syndrome. These two conditions have early onset in childhood and present with seizures that are difficult to control.

The syndromes have impacts that grossly affect the child’s development and overall quality of life. This news is huge for the medical and autism community; as this is the first time the FDA has approved a marijuana-derived substance.

Where to Buy CBD Oil for Autism

Because of the FDA, no company can sell or market CBD oil specifically for autism, ADHD, or any sort of special needs. This would be making claims not yet confirmed by the FDA.

When looking for CBD oil for autism, you’ll need to investigate on your own if the company is a high-quality supplier.

You’ll want to make sure the company uses true, “Full-Spectrum” CBD, offers a Certificate of Analysis, and has their product 3rd Party Tested.

While you should always do your own research, we at Harkla have tried and really like Natural Stacks CBD Oil combination.

They have 2 different blends. One of which you take in the morning that comes with Omega-3, which is important for inflammation and brain development, and another which is blended with melatonin and lavender oil for a great bedtime combination.

The team at Natural Stacks was kind enough to give us a discount code exclusively for those coming from our site!

If you use the code “S397N986CPEY” while checking out, you’ll save 15% off your order!

What’s Next?

Efforts to legalize cannabis continues –although there are significant concerns that it will become more available to adults and teens, and its dangerous effect on brain development. You probably see the movement in your own states and communities, depending on where you live. In the meantime, activist groups like MAMMA (Mothers Advocating Medical Marijuana for Autism) are working tirelessly to add autism as a qualifying condition for medical marijuana use in certain states where it is already legal.

Continued research involving CBD and autism is needed to continue to validate these incredible anecdotal reports. US-based studies are necessary to influence decision-makers in our country. Fortunately, there are more studies coming, which will be conducted in the United States.

Large grants and donations have been allocated for research out of the University of California San Diego and Montefiore Medical Center in New York as well as New York University. There was a $4.7 million dollar gift for medical marijuana research specific to autism, the largest private gift for cannabis research in our country.

Safer production, consistent packaging, and streamlined recommendations are needed for medical use of CBD oil. PCP involvement in monitoring the use of CBD oil is crucial – especially to watch for interaction with other drugs, liver health, and symptom management. Patient education about all of these issues is necessary to create informed consumers to validate this new “miracle drug”.

We are at an exciting point as we watch cannabis products, especially CBD oil, become more mainstream in our pool of alternative therapies for autism.

Although with marijuana, there can be a risk to the developing brain and the fear of access for all teens/children, it’s not hard to see why legalization is so difficult. These same risks don’t seem to exist with CBD Oil.

There are so many positive impacts of CBD for conditions that aren’t easily remediated, many of which are the core symptoms of autism. But safety is still a concern.

It’s hard to ignore those accounts of children who have never spoken, of individuals whose behaviors were so difficult but untouched by conventional drug therapies. A parent will do anything to help their child but should know how the risks and benefits compare.

References:

Molly Shaw Wilson MS OTR/L BCP

Molly Shaw Wilson MS OTR/L BCP is a board-certified pediatric occupational therapist with 16 years experience. She owns a private practice and provides service in homes, community and school settings, as well as her outpatient sensory clinic.

Molly enjoys working with young children and their families, focusing on parent-child interactions and home routines. She is a regular contributor to a parenting blog about typical development. Her professional interests have stemmed from her certificate work in assistive technology, hippotherapy practice, and consultation to a nature-based program in New Hampshire.

To find out more about Molly, please visit her website at www.trainingwheelsnh.com

34 Responses

Thanks for the info Molly. I’m an OTA and my husband is an OTR. Our young son is severely Autistic and we have been researching CBD as a means to regulate his behaviors.

Nicole

January 27, 2020

There are many brands that come in tincture form and can be mixed with juice or any food your child likes. You might consider joining the CBD for Kids group on Facebook to get more info on specific brands that meet your child’s individual needs!

All the best,
Nicole from Harkla

Linda DeJesus

January 27, 2020

Thanks for your article….very interesting information as I am considering trying CBD with my 14 year old daughter who has Autism. I appreciate the link to the company/product you recommended, however I have not yet been able to get my daughter to swallow pills. Any other recommendations or suggestions other than a pill? Thanks in advance for your help ! Sincerely, Linda

Nicole

January 15, 2020

Thanks for reading our blog! I found this link: https://cbdstore.co.za/ for you to look for CBD oil in South Africa. We wish you all the best and please let us know if you have any other questions.

-Nicole from Harkla

Kathy

January 15, 2020

Good Day, we live n Durban, South Africa. Please advise where can I get CBD oil from. There are so many different products in the market so not sure. I have a 5 going on 6 year old boy who is non-verbal, broad spectrum autism. His neurologist put him on rispedal, which I don’t see working honestly. His tantrums at times are unbearable. Many Thanks

myphysicalwellbeing

December 03, 2019

thanks for the information

Nicole

November 08, 2019

It is possible to feel nauseous after taking CBD oil. It’s not extremely common but possible. I would make sure you’ve eaten before taking a dose. That might help!

Thanks for reading our blog!
Nicole from Harkla

James W

November 08, 2019

Have you ever felt sick to your stomach after taking CBD oil?

Kerri Davis

November 08, 2019

I stumbled across this website searching (again) out of desperation for help with my 9.5 ur old daughter with hfa she has sensory processing disorder and has also been diagnosed with arfids she shows alot of the typical hfa traits but interestingly she also changed and stopped eating after a nasty virus before that she ate just fine, this happened just before age 2 she’s just entering early puberty, wS always a challenging child but now and f orly recently she’s almost unmanageable for us, we live in New Zealand I’d love to hear more about cbd oil can we get it here or import it? and also love to hear from anyone else whose child changed after a bad virus thank you for your time and.. help. please

Jennifer

October 23, 2019

I just want to say exercise caution. Anxiety in children with autism, is not the same as anxiety experienced by neurotypical individuals. Just because you have taken off the “jacket”’ of anxiety, does not mean they can suddenly accept, process and regulate sensory input. Anxiety is painful—however I do believe it serves some purpose. Again, proceed cautiously.

Norma

I noticed one reply in here mentioning PANDAS & I have to say, if your ASD child starts having OCD/Tick symptoms, becomes aggressive, regresses, becomes emotionally more volatile, has increased anxiety or becomes clingy, please, please, please look in to PANDAS & PANS. These are acquired conditions related to exposure to bacteria. PANDAS is specifically related to exposure to strep that is not fully treated. As strep hide in the brain waiting to become active, the cells hide by masking themselves to look like brain tissue. The body’s natural immune system detects the irregularity and creates antibodies that not only attack the strep but also the brain tissue causing an autoimmune response in the basal ganglia region of the brain. That region is now thought to control OCD, tics, anxiety & the regulation of mood and behavior. Once the body has learned to create these specific antibodies, any subsequent exposure to strep that your child has can trigger more antibodies to be created & you will see a return to bad behavior.

My son was born 15 weeks premature and later diagnosed with PDD/NOS which later became ASD. Every time something unusual occurred with his behavior, such as the onset of OCD, aggression, mood swings, regression, self harm, etc. I was told it was just the progress of his ASD. His initial diagnosis of ASD was dubious at best but it got him additional services such as ABA therapy so we went along with it. You see, he is nearly blind so if he doesn’t make eye contact, is it ASD or poor vision. He is nonverbal which is classic ASD but he also spent the first three years of his life on a ventilator. He lacked physical coordination & body awareness often associated with ASD but later it turned out he had Ehlers-Danlos Syndrome which could account for both. Because of his complex birth complications and lack of a definitive genetic problem, it became easy for him to be considered ASD & to attribute all of his ensuing behavior issues to ASD.

Recently his behavior got so bad he was harming himself constantly & others as well. The powers that be said it was hormones since he was 13. But then he got strep again & even with multiple treatments of antibiotics, he kept testing positive for strep so the doctor ran a test on his strep antibodies to see if his levels were high enough to attribute his issues to PANDAS. The test came back normal. He got strep again & again & again for months & finally a specialist ran a different test for the antibodies. Anything above 200 is abnormal. 400 & above is very abnormal. My son was 1400. While reviewing his history, it became clear that there has been a historic correlation between his swings in behavior & subsequent treatment with antibiotics for a variety of illnesses. His body has been attacking his brain for more than a decade and then when he would catch something like pneumonia or strep or while fighting a battle he had with MRSA, his brain would get a small break from the rising strep antibodies and his behavior would get better. Doctors attributed that to simply a change because he felt better physically & not to the fact that he had PANDAS that was being treated as a byproduct of treating something else.

I know this is a lot of rambling, but please once again. If you notice your child’s behavior is changing & you can’t figure out why, look at PANDAS & PANS. There are a lot of parents who are turning to CBD to help lower the inflammation in the brain caused by the strep antibodies & also to terpines. I wish there was more research on which components are the most helpful and milligrams to use, etc.

Oral Cannabidiol Use in Children With Autism Spectrum Disorder to Treat Related Symptoms and Co-morbidities

Objective: Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Several studies are being conducted worldwide on cannabidiol use in ASD; however, these studies are still ongoing, and data on the effects of its use is very limited. In this study we aimed to report the experience of parents who administer, under supervision, oral cannabinoids to their children with ASD.

Methods: After obtaining a license from the Israeli Ministry of Health, parents of children with ASD were instructed by a nurse practitioner how to administer oral drops of cannabidiol oil. Information on comorbid symptoms and safety was prospectively recorded biweekly during follow-up interviews. An independent group of specialists analyzed these data for changes in ASD symptoms and drug safety.

Results: 53 children at a median age of 11 (4–22) year received cannabidiol for a median duration of 66 days (30–588). Self-injury and rage attacks (n = 34) improved in 67.6% and worsened in 8.8%. Hyperactivity symptoms (n = 38) improved in 68.4%, did not change in 28.9% and worsened in 2.6%. Sleep problems (n = 21) improved in 71.4% and worsened in 4.7%. Anxiety (n = 17) improved in 47.1% and worsened in 23.5%. Adverse effects, mostly somnolence and change in appetite were mild.

Conclusion: Parents’ reports suggest that cannabidiol may improve ASD comorbidity symptoms; however, the long-term effects should be evaluated in large scale studies.

Introduction

Children with autism spectrum disorder (ASD) commonly exhibit co-morbid symptoms of hyperactivity, self-injury, aggressiveness, restlessness, anxiety and sleep disorders (Mannion and Leader, 2013; South et al., 2017). Conventional medical treatment includes various psychotropic medications such as atypical anti psychotics, selective serotonin reuptake inhibitors (SSRI’s), stimulants and anxiolytics (Canitano and Scandurra, 2008; Stachnik and Gabay, 2010; Wink et al., 2010; Hurwitz et al., 2012).

Several studies are being conducted worldwide on the use of cannabidiol in children with ASD to treat comorbid symptoms. However, there is limited published data on the use of cannabinoids in this population (Kurz and Blaas, 2010; Kuester et al., 2017). A recent review has suggested cannabidiol as a candidate for treatment of ASD (Poleg et al., 2019). Cannabis contains numerous chemically active compounds, including Δ9-tetrahydrocannabinol (Δ9-THC), cannabidiol (CBD) and terpenoids (Russo, 2011). Δ9-THC activates the endocannabinoid system in the central nervous system, affecting appetite, anxiety, cognitive function and memory (Palmieri et al., 2017). In contrast, CBD is anxiolytic, anti-inflammatory, antiemetic and antipsychotic (Detyniecki and Hirsch, 2015). Studies in mice models of ASD have demonstrated the involvement of the endocannabinoid system in the pathogenesis of ASD symptoms (Foldy et al., 2013; Wei et al., 2015).

In this study we aimed to record the experience of parents who administered under supervision cannabidiol to their children with ASD.

Materials and Methods

Included were children from all over Israel diagnosed with ASD based on DSM IV (American Psychiatric Association, 2000) or DSM V (American Psychiatric Association, 2013) criteria, between three and 25 years of age, who were followed up for at least 30 days after commencement of cannabidiol treatment. An independent group of specialists including a pediatric neurologist specialized in ASD, clinical pharmacologists and pharmacists objectively analyzed the data recorded during the follow up to assess symptom response and adverse effects. Four ASD comorbidity symptoms were evaluated: (a) hyperactivity symptoms (b) sleep problems, (c) self-injury and (d) anxiety.

For each comorbid symptom, the evaluations marked improvement, no change, or worsening of symptoms, as compared to the baseline, according to the parent’s reports. An overall change was defined based on the summation of all parent’s reports.

Children were recruited from a registry of patients with authorization to obtain cannabidiol (Tikun Olam Inc., Israel). Parents received a license for pediatric use of CBD from the Israeli Ministry of Health. The cannabinoid oil solution was prepared by “Tikun Olam” company, which is an approved supplier, at a concentration of 30% and 1:20 ratio of cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC). Quality assurance of the cannabidiol concentrations are routinely performed by HPLC on an Ultima 3000 Thermo Dionex instrument. Recommended daily dose of CBD was 16 mg/kg (maximal daily dose 600 mg), and for THC- daily dose of 0.8 mg/kg (maximal daily dose of 40 mg).

For all participating children this was their first experience with cannabidiol and no other cannabinoids were used before this study. During the first meeting, parents were instructed by an experienced nurse practitioner how to administer the preparation. Thereafter, a biweekly follow-up telephone interview was conducted with the parents. During the telephone interview, parents were asked on the status of the various ASD comorbid symptoms (graded as improvement, no change, worsening), emerging adverse effects and medications that had been used. Adverse events were coded using the Medical Dictionary for Regulatory Activities (Food Drug Administration, 2004). The change in each comorbid symptom in the study cohort was compared to published data using conventional treatment. For this purpose we used the following values: Hyperactivity symptoms- Improvement was considered as 80% (Handen et al., 2000), for self-injury an improvement was considered as 82% (Richards et al., 2016), for sleep problems an improvement was considered as 60% (Devnani and Hegde, 2015), and improvement in anxiety symptoms was considered as 64% (Moore et al., 2004).

The Study Was Not Financially Supported by Tikun Olam Company

The study was approved by the local research ethics committee. The need for written parental consent for this study was waived by the Assaf Harofeh Medical Center research ethics committee.

Statistical Analysis

Categorical variables such as gender, related ASD comorbid symptoms, were described using frequency and percentage. Continuous variables such as age and daily CBD dose were evaluated for normal distribution using histograms and Q–Q plots. Normally distributed continuous variables were described as mean and standard deviation and skewed variables were expressed as median and interquartile range or range. Length of follow-up was described using a reverse censoring method. A comparison of improvement in symptoms between CBD treatment and conventional treatment was analyzed using binomial test. All statistical analyses were performed using SPSS (IBM Corp 2016. IBM SPSS Statistics for Windows, Version 24.0, Armonk, NY: IBM Corp.).

Results

Fifty- three patients were included in the study, 45 males (85%) and 8 females (15%). The median age was 11 (range: 4–22) years (Table ​ (Table1). 1 ). Median duration of follow-up was 66 (range: 30–588) days. THC median interquartile range (IQR) daily dose was 7 (4–11) mg and CBD median (IQR) daily dose was 90 (45–143) mg.

Table 1

Patients characteristics and baseline symptoms.

Characteristics
Sex, n (%) Male 45 (84.9)
Female 8 (15.1)
Age (years), median (range) 11 (4–22)
Medications, n (%) Stimulants 5 (9.4)
Typical antipsychotics 6 (11.3)
Atypical antipsychotics 31 (58.4)
Anti-epileptic 8 (15)
Melatonin 4 (7.5)
Anti-depressant 2 (3.7)
Other anti-muscarinic 3 (5.6)
Alpha agonist 1 (1.8)
Days of treatment (days) Minimum 31
Maximum 588
Median 66
Hyperactivity symptoms, n (%) 47 (88.7)
Sleep problems, n (%) 29 (54.7)
Self-injury, n (%) 47 (88.7)
Social communication and reciprocity, n (%) 22 (41.5)
Anxiety, n (%) 26 (49.1)

Six children were excluded because they were treated for less than a month. None of them has discontinued treatment nor had adverse effects. A total of 266 interviews were performed (median 5 interviews per patient).

After Cannabidiol Administration, Parents Reported on the Various ASD Comorbid Symptoms as Follows

Hyperactivity Symptoms

Reports on 38 children with hyperactivity symptoms were recorded. Of them, 68.4% had improvement of symptoms, 28.9% had no change and worsening of symptoms was reported in 2.6%. The improvement was not statistically different from that of the conventional treatment published in the literature (p = 0.125).

Self-Injury

Of 34 reports on self-injury and rage attacks, 67.6% were reported to experience improvement of symptoms, 23.5% had no change, and worsening of symptoms was reported in 8.8%. There was a borderline significance in improvement of symptoms comparing to the conventional treatment (p = 0.063), and no statistical difference in worsening of symptoms (p = 0.307).

Sleep Problems

Reports on 21 patients with sleep problems were recorded. Of 21 reports, 71.4% improved, 23.8% had no change, and worsening of symptoms was reported in one patient (4.7%). There was no statistically difference comparing to the conventional treatment (p = 0.4).

Anxiety

Reports on 17 patients with anxiety symptoms were available. Of 17 reports, eight patients (47.1%) had improvement of symptoms, five patients (29.4%) had no change, and worsening of symptoms was reported in four patients (23.5%). There was no statistically difference comparing to the conventional treatment as published in the literature (p = 0.232).

Overall Improvement

We examined the overall change in ASD comorbidities symptoms of 51 out of 53 patients (Table ​ (Table2). 2 ). An overall improvement was reported in 74.5%. No change was reported in 21.6% and worsening in 3.9%. Two patients did not have a report on their overall improvement.

Table 2

Overall change in ASD comorbidity symptoms.

Change in symptoms Frequency
No change, n (%) 11 (21.6)
Improvement, n (%) 38 (74.5)
Worsening, n (%) 2 (3.9)
Total 51
Missing reports 2
Adverse Events Reported by the Parents

The most frequent adverse effects were somnolence (n = 12) and decreased appetite (n = 6) (Table ​ (Table3 3 ).

Table 3

Adverse events possibly related to the study, according parent’s reports.

Adverse events Number of reports
Somnolence 12
Appetite decrease 6
Appetite increase 4
Insomnia 2
Sense abnormality response (to temperature) 2
Eyes blinking 2
Diarrhea 2
Hair loss 1
Nausea 1
Confusion 1
Acne 1
Palpitations 1
Urinary incontinence 1
Eye redness 1
Constipation 1

Five families discontinued follow-up at different time points. Two families reported ineffectiveness and chose to stop treatment; two families decided to continue treatment with a different medical cannabis supplier and in one family the license expired.

Discussion

In this study, based on recorded data reported by parents of children with ASD, in all four ASD comorbidity symptoms described, parents have reported an overall improvement.

This is one of the first publications on the use of cannabidiol to treat comorbid symptoms of patients with ASD. There are studies which are being conducted these days in several countries such as the United States and Israel, to examine the efficacy and safety of cannabidiol in this population; however, these studies are still ongoing.

The incidence of hyperactivity symptoms in the ASD population ranges between 41 and 78% (Sturm et al., 2004; Murray, 2010). In our study there was an overall improvement of 68.4% [95%CI (51.4–82.5%)] in hyperactivity symptoms as reported by the parents. Conventional treatments for hyperactivity include treatment with methylphenidate. In one study, methylphenidate improved symptoms in 80% (Handen et al., 2000). Comparing the overall improvement in hyperactivity symptoms in children treated with cannabidiol to that achieved with methylphenidate, non-inferiority of cannabidiol was observed (p = 0.125).

Self-injurious behavior is common in ASD, with incidence ranging between 35 and 60% (Richards et al., 2016). Our study presented an overall improvement of 67.6% [95%CI (49.5–82.6%)] and worsening of 4.9% [95%CI (1.9–23.7%)] in these symptoms. Currently, atypical antipsychotics are recommended for the treatment serious behavioral symptoms and self-injury (Marcus et al., 2009). Aripiprazole improves symptoms in 82% (any improvement) while 4% presented worsening in symptoms (Marcus et al., 2009). Comparing the overall improvement and worsening in self-injury symptoms in children treated with cannabidiol in our study to that described in the literature with aripiprazole, non-inferiority of cannabidiol was observed (p = 0.063, p = 0.307, respectively).

Sleep problems in children and adolescents with ASD range between 40 and 80% (Devnani and Hegde, 2015). Conventional treatment with melatonin improved sleep problems in 60% of the patients (Devnani and Hegde, 2015). In our present study cannabidiol was reported to be effective in 71.4% [95%CI (47.8–88.7%)] of the patients in improving sleep problems. Comparing the overall improvement in sleep problems in children treated with cannabidiol to that reported in children treated with melatonin, non-inferiority of cannabidiol was observed (p = 0.40).

Anxiety symptoms in children with ASD are common (Sukhodolsky et al., 2008) and are usually controlled with selective serotonin reuptake Inhibitors (SSRI’s) treatment in 55–73% (Moore et al., 2004). In our study, reports on 17 patients with these symptoms were recorded and in 47.1% [95%CI (23.0–72.2%)] of the children an improvement of symptoms was reported. It has been suggested that by improving sleep and disruptive behavior, the motivation and the ability to communicate with the family and the caregivers is improved. Comparing the overall improvement in anxiety symptoms in children treated with cannabidiol to that reported in children treated with SSRI’s, non-inferiority of cannabidiol was observed (p = 0.232).

Δ9-THC and CBD are substrates and inhibitors of cytochrome P450 enzymatic pathways relevant to the biotransformation of commonly prescribed psychotropic agents (Rong et al., 2018). Δ9-THC is rapidly metabolized by CYP2C9 and CYP3A4 isoenzymes and CBD is metabolized by CYP2C19 and CYP3A4 (Stout and Cimino, 2014). Data suggest minimal induction of CYPs 1A2, 2C9, 2C19, and 3A4 by Δ9-THC and CBD. However, drug–drug interaction should be considered; phenytoin plasma concentration might be increased, even up to toxic range (Rong et al., 2018). Animal studies have demonstrated that the exposure to Δ9-THC may reverse the neurobehavioral effects of risperidone, which may be less effective (Brzozowska et al., 2017). Other potential drug–drug interactions of cannabidiol include SSRI’s, tricyclic antidepressant and CNS depressants which may result in toxic levels of these medications (Lindsey et al., 2012). In our study, signs and symptoms of toxicity of these medications were not reported.

Most frequent adverse effects, as reported by the parents, were somnolence and change in appetite (Table ​ (Table3). 3 ). These symptoms were perceived by the parents as related to the treatment with cannabidiol. All adverse effects were reported to be transient and resolved spontaneously. Several studies have demonstrated that the most common adverse effects associated with CBD use in children and adults are somnolence, change in appetite, diarrhea, and weight changes (Devinsky et al., 2016). Case-studies indicate that cannabinoids may induce acute psychosis which is self-limited over time (Shah et al., 2017); however, cannabis is not considered as the only cause for persistent psychotic disorder. More likely it is the interaction of several factors, such as age at onset of cannabis use, childhood abuse, genetic vulnerability and psychiatric comorbidities which result in psychosis (Wilkinson et al., 2014). Patients with a history of psychotic attacks are more likely to develop cannabis induced psychotic attacks and this should be a contraindication for treatment with CBD (Degenhardt et al., 2018).

Our study has several limitations. All information was based on parents’ reports, with no control group, and there was no objective assessment tool for symptoms changes. We did not have information on the history of ASD symptoms in each patient.

Parents may subjectively report an improvement due to high expectations from the treatment. However, we believe that the main caregivers are the best source to evaluate the child’s status and adverse events. In this population of children with ASD, adverse events are reported by the caregivers rather than the medical staff. Several studies, examining the efficacy and safety of cannabidiol in children with epilepsy, based upon parents’ report, were published in the medical literature (Porter and Jacobson, 2013). Furthermore, our study was conducted on a cohort of patients who were followed up consistently, and not a case series; hence, the rates of treatment success or failure are calculated based on a genuine denominator.

Conclusion

Children with ASD commonly have comorbid symptoms such as aggression, hyperactivity and anxiety. There is an increase in the use of cannabidiol in children with ASD. Based on parents’ reports, our findings suggest that cannabidiol may be effective in improving ASD comorbid symptoms; However, CBD efficacy and safety should be further evaluated in children with ASD in large-scale clinical trials.

Author Contributions

DB, OS, TD-H, and MB performed the major research in equal contribution. TZ-B provided the statistical analysis. DF, GK, and NS contributed as consultants.

Conflict of Interest Statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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