Treatment With Cannabis Oil Containing CBD Only or 20:1 CBD:THC vs. Placebo of Persons With ADHD
ADHD is the most frequent neuro-developmental disorder in childhood and often continues into adolescence and adulthood.
Indicated drug treatments for ADHD fall into 2 categories: stimulants (such as methylphenidate and amphetamines) and non-stimulants (such as atomoxetine, guanfacine and clonidine) but some persons cannot tolerate their secondary effects or find them non-effective.
In the last decade, medical cannabis products have been researched as possible treatment for neurological and mental diseases such as: Post trauma disorder (PTD), autism (ASD), epilepsy, fibromyalgia (FM) and more.
Data on the effects of cannabidiol rich cannabis extract use for ADHD seems promising but is still limited. The aim of this study is to investigate if oral cannabinoids given to adults with ADHD affect the symptoms of the disorder.
The main objectives of the study are: 1) to characterize the effects of treatment with cannabis oil on symptoms of ADHD; 2) to compare safety and efficacy of cannabis oil products with different CBD,Cannabidivarin (CBDV), cannabigerol (CBG) and THC ratio; 3) and to measure endocannabinoids, THC and CBD and metabolites levels in the blood of the participants.
In this study, participants diagnosed with ADHD will be treated with canabidiol-rich cannabis oil and will follow up weekly during approx.1 month (the study period). Blood tests will be performed before and after treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and their metabolites. Test of Variables of Attention test (TOVA) will be administrated before and after treatment
|Condition or disease||Intervention/treatment||Phase|
|ADHD Hyperactivity Attention Deficit||Drug: Cannabis oil||Phase 2|
Participants will be screened by study staff for ADHD diagnosis and failure of conventional treatment.
Participants passing the screening will undergo blood and urine tests, fill questionnaires, TOVA test and will be randomized to one of the 4 arms.
Participants will receive the drug, be instructed as per dose titration and as per danger of driving under drug influence.
Telephone follow up will take place weekly after 7 days from starting. Participants will guess to which arm the participant was allocated to after 2 weeks of treatment .
Participants will arrive for a last visit, fill questionnaires, do TOVA test and undergo blood and urine tests.
Participants will be contacted over the phone for a last time, after treatment completion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||each participant will be randomized to one of the 4 arms and will receive the treatment for 32 days. Follow up till 6 weeks from starting|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||the responsible pharmacist is un-blinded|
|Official Title:||Treatment With Cannabis Oil Containing Cannabidiol (CBD) Only or 20:1 CBD: Tetrahydrocannabinol (THC) vs. Placebo of Persons Diagnosed With Attention Deficit Hyperactive Disorder (ADHD) After Failure of Conventional Treatment|
|Estimated Study Start Date :||April 2022|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
Cannabis oil oral drops containing 95 mg/ml CBD; 5 mg/ml THC; 15 mg/ml CBDV ; no CBG, once daily Titration from 0.3 to 1.8 ml/day during 21 days
Cannabis oil oral drops containing no CBD; 5 mg/ml THC; no CBDV; 95 mg/ml CBG, once daily.
Titration from 0.3 to 1.8 ml/day during 21 days
Cannabis oil oral drops containing 47.5 mg/ml CBD; 2.5 mg/ml THC; 7.5 mg/ml CBDV; 47.5 mg/ml CBG, once daily.
CBD Oil for ADHD: Research, Considerations, and Side Effects
Kendra Cherry, MS, is an author and educational consultant focused on helping students learn about psychology.
Verywell Mind articles are reviewed by board-certified physicians and mental healthcare professionals. 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.
Steven Gans, MD is board-certified in psychiatry and is an active supervisor, teacher, and mentor at Massachusetts General Hospital.
Verywell / Alex Dos Diaz
Cannabidiol (CBD) is a compound found in cannabis that is purported to have a number of mental health effects. This has led many people to speculate that it might also have potential uses in the treatment of attention deficit hyperactivity disorder (ADHD).
Before you decide to try it, it is important to learn more about what CBD oil is, what the research says about what it can do, and what benefits and side effects it might have for alleviating symptoms of ADHD.
ADHD is a neurodevelopmental disorder that is most often diagnosed during childhood. It can cause symptoms including inattention, hyperactivity, and impulsivity.
What Is CBD Oil?
CBD oil is derived from the marijuana plant. CBD is extracted from the cannabis plant and mixed with a carrier oil such as hemp seed oil, grapeseed oil, olive oil, or sunflower oil. Studies suggest that it appears to be relatively safe and well-tolerated, although further research is needed to look at the possible long-term effects.
The cannabis plant contains hundreds of different compounds. The best known of these is tetrahydrocannabinol (or THC) and it is the most abundant. It is also the substance responsible for marijuana’s psychoactive effects. In other words, THC is what causes people to experience the euphoric high associated with marijuana use.
CBD, on the other hand, is the second most abundant cannabinoid found in the cannabis plant. Although it will not cause the high that TCH will, it does have an effect on the brain and is associated with some mental health benefits, including potential benefits for people who have ADHD.
Reasons to Consider Using CBD
Some people who advocate for the use of CBD oil for ADHD suggest that:
- It might be more effective than some other treatments
- It might have fewer side effects than traditional medications
- Anecdotal evidence suggests it may help with ADHD symptoms
- It may have other mental health benefits
Part of the appeal of using CBD oil may be to avoid some of the side effects that are associated with traditional ADHD treatments.
While the Centers for Disease Control and Prevention (CDC) reports that between 70 and 80% of kids who have ADHD experience a reduction in symptoms after taking stimulant ADHD medication, they can cause side effects including sleep issues, decreased appetite, and mood changes.
Before you decide to try CBD oil to treat ADHD, it is important to consider the available research. Most importantly, you should always talk to your doctor before you try any alternative remedies.
So what do the experts have to say? Is CBD oil really effective for treating ADHD? Interest in the use of CBD has largely outpaced the research into its uses, safety, and effectiveness.
While some proponents have made a number of claims, the truth is that research on the use of CBD as a treatment for ADHD is extremely limited. Most of what researchers already know stems from research on the use of smoked or ingested marijuana and not directly on the effects of CBD oil or other CBD products.
Even the available studies on the use of marijuana in the treatment of ADHD is very limited. Many of these studies also rely on self-reported data, which does not provide as much support as a randomized clinical trial.
CBD May Reduce Hyperactivity
A 2013 study looked at cannabis use and ADHD subtypes. The data collected from more than 2,800 participants found that people were more likely to self-report hyperactive-impulsive symptoms when they were not self-medicating with cannabis. This suggests that people who use marijuana to self-treat may find relief for symptoms of hyperactivity and impulsivity.
CBD May Reduce ADHD Symptoms
One small 2017 randomized controlled trial found that adults with ADHD treated with the cannabinoid medication Sativex (which contains THC and CBD) showed a minor reduction in ADHD symptoms with no cognitive impairments. However, it is important to note that these improvements were small and were not enough to demonstrate that cannabinoids were significantly more effective than treatment with a placebo.
A 2020 study found that higher doses of medical cannabis were associated with a decreased use of ADHD medication in adults. The products containing a higher dosage of CBD were associated with lower ADHD scores.
Further Research Is Needed
While such results suggest that cannabis and cannabinoid compounds have promise as treatments for ADHD, they don’t indicate that CBD oil on its own might have an impact on the symptoms of the condition. Further research is also needed to determine the role that the endocannabinoid system plays in attention deficit hyperactivity disorder.
CBD for ADHD Symptoms
While the evidence that CBD oil might be useful as a treatment for ADHD remains scant, it may be useful for managing some of the symptoms that are sometimes associated with the condition. ADHD is often associated with a variety of co-occurring conditions including anxiety and depression.
CBD has shown promise as a potential treatment for a number of mental health conditions, so it might be helpful for reducing symptoms of anxiety and depression in people who also have ADHD.
While further research is needed to explore CBD’s effects, some studies have shown that it can be effective in reducing symptoms of a number of anxiety conditions including generalized anxiety disorder, panic disorder, and social anxiety disorder. CBD has also been found to have an antidepressant-like effect, which may make it useful in the treatment of depression.
It is important to be aware that much of this research is still in the early stages. More work needs to be done to explore the effects of CBD, what conditions it may treat, and what doses may be the most effective.
If you are thinking of taking CBD, you should also be aware that while it is usually well-tolerated, it may lead to some side effects.
Potential Side Effects
CBD oil may cause a number of side effects. Although many of these symptoms are mild, it’s important to note some of the common complaints:
- Appetite changes
- Mood changes
- Stomach upset
Side effects may be more common at higher doses, although research suggests that CBD appears to be safe and well-tolerated at doses up to 1,500 mg per day. It is also important to note that CBD can impact the metabolism of certain medications.
In addition to the most common side effects, there are also concerns about the potential worsening of some ADHD symptoms. Some of the effects associated with marijuana use are also common symptoms of ADHD.
While CBD oil does not have psychoactive properties, it may also contain small amounts of THC, which could potentially exacerbate some ADHD symptoms.
The memory and attention impairments that are associated with the use of cannabis are one potential concern.
In an article published in the New England Journal of Medicine, Dr. Nora Volkow, director of the National Institute on Drug Abuse (NIDA), points out many of the potential negative side effects of marijuana use. Among these are impaired attention and memory, problems that can be long-term and become worse with chronic cannabis use.
Another concern is that ADHD can be a risk factor for drug and alcohol misuse. Having impulsive symptoms may cause people to be more likely to misuse cannabis or develop a cannabis use disorder. This presents concerns when it comes to using cannabis or cannabis-related products in the treatment of ADHD symptoms.
Whether the use of CBD oil might contribute to later marijuana use remains unknown. However, marijuana can potentially have negative effects on things like attention and motivation. Young people who smoke marijuana can also experience lasting detriments to cognitive ability and IQ.
Some research suggests that very high doses may pose a risk of liver damage. In a study where mice were given very high doses of CBD, researchers observed that there was an increased risk for liver toxicity. Of course, more research is needed to determine if these same risks apply to humans.
So should you try CBD oil for ADHD? Some important things to remember:
- It shouldn’t be a substitute for other treatments. While there is evidence that CBD may have mental health uses, this does not mean that it is the best option for the treatment of ADHD. There are a number of effective treatments currently available to manage the symptoms of this condition. Until further evidence demonstrates the usefulness of CBD for this purpose, it is better to stick to known treatments that have a solid track record of effectiveness.
- Just because something is perceived as being more “natural” does not mean it is the best choice. CBD oil appeals to some people because it is seen as a natural product. But it is important to remember that “natural” does not necessarily mean that it will be safe. While CBD oil appears to have few or minor side effects in the short-term, researchers still are not sure about any long-term impacts it may have.
- We don’t know if it actually works. The jury is still out on whether CBD might be effective for treating ADHD and answers won’t become clear until further research is done.
- CBD oil and other CBD products are not regulated. When you purchase these products, you have no way of knowing if you are getting what you think you are getting. There are no regulations or manufacturing oversight that allows consumers to feel secure about the purity of the products that they are purchasing.
There are different types of CBD oil to choose from and it is unclear which CBD products might be helpful in the treatment of ADHD. These types vary depending on what they contain. CBD oil isolate contains only CBD. Broad-spectrum products contain CBD as well as other cannabinoids, but not THC. Full-spectrum products, on the other hand, contain CBD, THC, and other cannabinoids.
Some research has found that CBD may play a role in counteracting some of the negative side effects associated with THC.
When it comes to ADHD, people who are thinking of trying CBD oil need to understand that there is a major lack of research on the topic. There are no randomized controlled trials that indicate whether it is effective or ineffective. There is also no research comparing CBD oil to other treatments for ADHD.
How to Use CBD Oil
If you decide to try CBD oil for ADHD or other reasons, it is important to purchase it from reputable sources. Products containing CBD are frequently mislabeled, and since there is no federal regulation over these products, it is difficult to know exactly what you are getting.
There is also no research comparing the effects of different forms of CBD. In addition to being available as an oil, CBD can also be purchased as capsules, gummies, sprays, tinctures, candies, beverages, and vaping oils.
Is It Legal?
While CBD is growing in popularity, its legal status varies depending on where you live. All states permit CBD, but many have restrictions based on the THC levels found in the product. It is important to note that while many states have passed laws legalizing CBD and other cannabis products, any product containing more than 0.3% THC is illegal according to federal law.
The FDA has also issued warnings about companies illegally selling unapproved CBD products boasting unsupported claims about their effectiveness in the treatment of ADHD and other conditions including Alzheimer’s disease and autism.
The Federal Trade Commission Act prohibits manufacturers from claiming that a product can prevent, treat, or cure a disease unless such claims are backed by reliable scientific studies.
The FDA warns that consumers should be wary of such claims. “This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children,” explained FDA Acting Commissioner Ned Sharpless, M.D.
A Word From Verywell
While CBD oil and other CBD products may show promise for relieving some symptoms of ADHD, there simply is not enough evidence to support using it as a treatment for ADHD. If you do decide to try it, be sure to talk to your doctor first. Your doctor will be able to suggest the most effective and safest ways to help you better manage your symptoms.
Cannabinoids in attention-deficit/hyperactivity disorder: A randomised-controlled trial
Adults with ADHD describe self-medicating with cannabis, with some reporting a preference for cannabis over ADHD medications. A small number of psychiatrists in the US prescribe cannabis medication for ADHD, despite there being no evidence from randomised controlled studies. The EMA-C trial (Experimental Medicine in ADHD-Cannabinoids) was a pilot randomised placebo-controlled experimental study of a cannabinoid medication, Sativex Oromucosal Spray, in 30 adults with ADHD. The primary outcome was cognitive performance and activity level using the QbTest. Secondary outcomes included ADHD and emotional lability (EL) symptoms. From 17.07.14 to 18.06.15, 30 participants were randomly assigned to the active (n=15) or placebo (n=15) group. For the primary outcome, no significant difference was found in the ITT analysis although the overall pattern of scores was such that the active group usually had scores that were better than the placebo group (Est=-0.17, 95%CI-0.40 to 0.07, p=0.16, n=15/11 active/placebo). For secondary outcomes Sativex was associated with a nominally significant improvement in hyperactivity/impulsivity (p=0.03) and a cognitive measure of inhibition (p=0.05), and a trend towards improvement for inattention (p=0.10) and EL (p=0.11). Per-protocol effects were higher. Results did not meet significance following adjustment for multiple testing. One serious (muscular seizures/spasms) and three mild adverse events occurred in the active group and one serious (cardiovascular problems) adverse event in the placebo group. Adults with ADHD may represent a subgroup of individuals who experience a reduction of symptoms and no cognitive impairments following cannabinoid use. While not definitive, this study provides preliminary evidence supporting the self-medication theory of cannabis use in ADHD and the need for further studies of the endocannabinoid system in ADHD.
Keywords: Attention deficit-hyperactivity disorder; Cannabinoids; Randomised-controlled trial; Self-medication.
Copyright © 2017 Elsevier B.V. and ECNP. All rights reserved.
Weisler RH, Pandina GJ, Daly EJ, Cooper K, Gassmann-Mayer C; 31001074-ATT2001 Study Investigators. Weisler RH, et al. CNS Drugs. 2012 May 1;26(5):421-34. doi: 10.2165/11631990-000000000-00000. CNS Drugs. 2012. PMID: 22519922 Clinical Trial.
Weisler RH, Greenbaum M, Arnold V, Yu M, Yan B, Jaffee M, Robertson B. Weisler RH, et al. CNS Drugs. 2017 Aug;31(8):685-697. doi: 10.1007/s40263-017-0455-7. CNS Drugs. 2017. PMID: 28712074 Free PMC article. Clinical Trial.
Spencer TJ, Wilens TE, Biederman J, Weisler RH, Read SC, Pratt R. Spencer TJ, et al. Clin Ther. 2006 Feb;28(2):266-79. doi: 10.1016/j.clinthera.2006.02.011. Clin Ther. 2006. PMID: 16678648 Clinical Trial.
Babcock T, Dirks B, Adeyi B, Scheckner B. Babcock T, et al. BMC Pharmacol Toxicol. 2012 Dec 19;13:18. doi: 10.1186/2050-6511-13-18. BMC Pharmacol Toxicol. 2012. PMID: 23254273 Free PMC article. Clinical Trial.
Durell TM, Adler LA, Williams DW, Deldar A, McGough JJ, Glaser PE, Rubin RL, Pigott TA, Sarkis EH, Fox BK. Durell TM, et al. J Clin Psychopharmacol. 2013 Feb;33(1):45-54. doi: 10.1097/JCP.0b013e31827d8a23. J Clin Psychopharmacol. 2013. PMID: 23277268 Clinical Trial.
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Carreira LD, Matias FC, Campos MG. Carreira LD, et al. Biomedicines. 2022 Mar 29;10(4):796. doi: 10.3390/biomedicines10040796. Biomedicines. 2022. PMID: 35453548 Free PMC article. Review.
Mansell H, Quinn D, Kelly LE, Alcorn J. Mansell H, et al. Med Cannabis Cannabinoids. 2022 Jan 13;5(1):1-6. doi: 10.1159/000521370. eCollection 2022. Med Cannabis Cannabinoids. 2022. PMID: 35224434 Free PMC article.
Wallis D, Coatsworth JD, Mennis J, Riggs NR, Zaharakis N, Russell MA, Brown AR, Rayburn S, Radford A, Hale C, Mason MJ. Wallis D, et al. Int J Environ Res Public Health. 2022 Feb 7;19(3):1850. doi: 10.3390/ijerph19031850. Int J Environ Res Public Health. 2022. PMID: 35162872 Free PMC article.
Hua DY, Lees R, Brosnan M, Freeman TP. Hua DY, et al. BMJ Open. 2021 Dec 16;11(12):e053814. doi: 10.1136/bmjopen-2021-053814. BMJ Open. 2021. PMID: 34916323 Free PMC article.