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Cbd oil for autism clinical studies

The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Data on the effects of cannabidiol rich cannabis extract use for ASD is promising but still limited. The aim of this study is to investigate if oral cannabinoids treatment to children and young adults with ASD affect the comorbidities of autism, including sleep and eating problems, anxiety and violence.

The main objectives of the study are: 1) to characterize the effect of treatment with cannabis oil on comorbid symptoms of ASD; 2) to compare safety and efficacy of different cannabis products with identical CBD:THC ratio; 3) to investigate the effect of treatment on cognitive and adaptive behavior; and 4) to measure THC and CBD and metabolites levels in the blood of the patients.

In this study, patients diagnosed with ASD will be treated with cannabidiol-rich cannabis oil (CBD:THC ratio of 20:1). The researchers will collect parental reports on ASD comorbid symptoms before and bi-weekly during 6 months of the study period. Blood tests will be performed before and after three months of treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and metabolites. Cognitive evaluation will be done before and after six months of treatment. Electroencephalogram (EEG) to exclude epilepsy will be performed before and after six months of treatment.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Cannabis oil Phase 3

Participants will be screened by the PI, a specialist neurologist. For those passing screening, license for Cannabis will be obtained at MOH.

Participants will pass tests such as ADOS (communication skills) and Wechsler (IQ), parents will fill questionnaires.

Treatment will start in a titration mode till improvement in some parameters is seen or till treatment failure decision is made.

Participants will be called for a check-up by mid-time (after 3 months) and their parents will fill questionnaires.

Participants will be called for a last check-up after 6 months from treatment beginning and pass again ADOS and Wechsler tests. Parents will fill questionnaires.

Secondary purposes of the trial:

To detect side-effects To assess treatment failure To assess treatment effect on sleep, motor restlessness and behavior. To examine treatment effect on hormonal profile

Layout table for study information

Study Type : Interventional (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Actual Study Start Date : November 14, 2019
Actual Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 2022

cannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Seach LTD and oil manufactured by Nextar Pharma LTD.

cannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Candoc LTD and oil manufactured by Panaxia LTD.

    Cannabinoids levels change [ Time Frame: 3 months ]

To characterize the effect of medical cannabis treatment on the attention span using Conners teacher questionnaires. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

To examine the effect of cannabis treatment on cognitive level using part of Wechsler test. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

To compare efficacy of medical cannabis products with the same CBD: THC ratio in terms of communication skills using ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

To examine the effect of cannabis treatment on adaptive behavior as per ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

To examine the effect of cannabis treatment on violent behavior as per specific trial-designed questionnaire. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

    Side effects [ Time Frame: 6 months ]

To identify side effects as per parents report in a specific trial-designed questionnaire. Significant change is defined as a change of 10% in new side effects as examined by questionnaire score between baseline and 6 months.

To identify therapeutic failure reasons as per Professional expert opinion. Significant reason is defined as reason that will effect at least 20% of therapeutic failure cases.

To examine whether high concentration CBD cannabis oil is effective in improving sleep as per Sleep questionnaire. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

To examine whether high concentration CBD cannabis oil is effective in improving eating as per eating questionnaire. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

To compare hormonal profile measured as per by Hospital Lab SOP before and during treatment. measured hormones are: TSH, FT4, 17OH-testosterone, LH, prolactine. Significant change is defined as a clinically significant diversion from lab defined normal ranges, according to age and sex, between baseline and 3 months.

To compare liver enzymes measured as per by Hospital Lab SOP before and during treatment. Measured enzymes are: ALT, AST, GGT, Bilirubin. Significant change is defined as a clinicaly significant diversion (more than twice the Upper Limit of Noraml for each enzyme) from lab defined normal ranges, between baseline and 3 months.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study: 5 Years to 25 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
  • diagnosed with ASD by DSM
  • IQ below 70. The investigator can include patients with IQ above 70 if they have significant ASD or comorbid symptoms.
  • With significant behavior problems in for at least 6 months before recruitment
  • Epilepsy with clinical symptoms
  • Current or previous treatment with cannabis
  • Genetic disorder that can cause ASD symptoms
  • Metabolic disorder
  • immunologic disorder
  • liver cancer
  • Participants who, in the researcher’s opinion, will not cooperate in the various research procedures
  • Women which are pregnant or breastfeeding.
  • Psychosis or schizophrenia or past or present schizoaffective disorder, in first-degree relatives
  • History of substance abuse or abuse (including cannabis use disorder or alcohol addiction) in first-degree relatives
  • Hypersensitivity to coconut oil / palm oil

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05212493

CBD Oil as a Treatment for Autism

Lisa Jo Rudy, MDiv, is a writer, advocate, author, and consultant specializing in the field of autism.

Verywell Health articles are reviewed by board-certified physicians and healthcare professionals. These medical reviewers confirm the content is thorough and accurate, reflecting the latest evidence-based research. Content is reviewed before publication and upon substantial updates. Learn more.

Stephanie Hartselle, MD, is a board-certified pediatric and adult psychiatrist and Diplomate of the American Board of Psychiatry and Neurology.

Cannabidiol , sometimes called CBD, is a chemical compound found in the cannabis plant. The American Academy of Child and Adolescent Psychiatry does not support the use of any cannabinoids in children or teens for the diagnosis of autism.

In fact, CBD oil has been studied as a potential treatment for autism, but the results do not support its use in treating children or adults who have this disorder. And, according to Harvard Health Publishing, “because CBD currently is typically available as an unregulated supplement, it’s hard to know exactly what you are getting.”

Currently, there are some treatments that may alleviate some symptoms of autism, but there is no cure.

About CBD

CBD can be derived from hemp or cannabis (the marijuana plant) and is now legal in many states in the United States and in many countries around the world. It can be purchased without a prescription as an oil, tincture, pill, or chewable pill online and is also an ingredient in edibles ranging from coffee to pastries. It comes in many dosages and at many price points.

Claims for CBD range from the realistic to the absurd. Some websites and companies claim, for example, that CBD can cure cancer (it can’t). On the other hand, CBD does seem to alleviate some symptoms of disorders such as epilepsy, nausea, and muscle spasticity—all issues that can affect some people with autism. According to Harvard Health Publishing, “the strongest scientific evidence is for its effectiveness is in treating epilepsy disorders of Dravet syndrome and Lennox-Gastaut syndrome (LGS), which typically don’t respond to anti-seizure medications.”

The FDA has approved a cannabis-derived medicine for the treatment of certain types of epilepsy, Epidiolex, which contains CBD.

It’s important for parents to know that CBD is not helpful for everyone who uses it, and it can cause side effects, such as sleepiness or nausea.

CBD and Autism

Neither CBD nor any other drug can remove or cure core symptoms of autism, which include social communication challenges, sensory dysfunction, and restricted, repetitive behaviors.

CBD can, however, help to alleviate epilepsy in some children and adults with autism. Fewer seizures can lessen stress and make it easier to interact socially.

Research Findings

A few full-scale studies have explored the impact of CBD on children with autism—none, however, have explored its impact on adults on the spectrum. One of the largest such studies took place in Israel. The report includes the following finding:

“In 2014, The Ministry of Health began providing licenses for the treatment of children with epilepsy. After seeing the results of cannabis treatment on symptoms like anxiety, aggression, panic, tantrums and self-injurious behavior, in children with epilepsy, parents of severely autistic children turned to medical cannabis for relief.”

Studies are ongoing in clinics and research centers around the world.

Before Trying CBD

Before considering CBD oil, it’s important to follow these steps:

  • Check with your child’s (or your) doctor to be sure that no allergies or sensitivities exist that could cause a reaction to CBD.
  • Check with your child’s doctor to see if the medical benefits of CBD oil are relevant to your child’s symptoms.
  • Check to be sure that CBD is legal in your state, province, or country.
  • Research sources of CBD to be sure the brand you’re using is well-regarded and properly licensed.
  • Take careful notes about your child’s (or your own) behaviors and symptoms so that you can make a useful comparison before and after using CBD.

Using CBD

CBD comes in many forms and at many dosage levels, including candy forms. It’s important to keep candy-like drugs and supplements out of the reach of children.

Lower doses are more easily tolerated than higher doses.

When you start using any new supplement, drug, or treatment, it’s important to be sure your child’s doctor is aware of the new treatment and has no concerns about it relative to your child’s health. Let everyone working with your child know that you’ve started something new and ask them to look for and report any changes in behaviors or skills.

Take careful notes of any changes you see so you can easily review your records to determine how helpful the new treatment really is. Keep an eye open for any troubling side effects. Be sure to communicate any side effects to a doctor or healthcare professional immediately.

A Word From Verywell

Children with autism grow and learn every day, simply because they are maturing. As a result, there is no simple way to determine whether a change in behavior or an increase in skills is due to a particular treatment or to ordinary maturation. This reality makes it very easy to see a change in behaviors and inaccurately attribute them to the newest treatment you’ve tried. By far, the best way to know whether a particular treatment is truly effective is to be rigorous about evaluating your child before and after its use.