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Tuesday, October 31, 2017

CBD oil (cannabidiol) and ADHD

CBD oil (cannabidiol) is a hot new treatment for ADHD and other associated conditions such as anxiety and epilepsy.  Many patients who have not had good results with standard therapies for ADHD are turning towards CBD oil, as well as other alternative therapies, with hopes of better outcomes.

CBD oil is extracted from the whole hemp plant and is not the same as marijuana oil, honey oil,  or THC oil, although all are derived from the cannabis plant.  Hempseed oil is the subject of an upcoming article on this blog and does not contain CBD oil.   Hemp oil may or may not contain CBD oil.  Typically products marketed as hemp oil are actually hempseed oil, but you can never be sure unless you ask.  CBD oil is thought not to generate a high, as does THC, the active ingredient of marijuana.  It is also not usually smoked, but is usually rubbed on the skin or taken orally.

Risks
Although some manufacturers claim that CBD oil can be made in a legal way, either as “CBD only” or as extracted from imported hemp, the US Drug Enforcement Administration (DEA) clearly considers CBD oil to be a Schedule I drug due to the presence of trace amounts of THC in all existing preparations.   Unfortunately, other parts of the cannabis plant can contaminate hemp during the CBD oil extraction process, and while trace amounts won’t make you high, they are still THC.    A schedule I drug is illegal to possess, unless it is under an expanded access program for investigational drugs.  Research can be legally done on CBD oil only under special permits from the federal government.  This puts prescribers and users at risk for arrest, legal proceedings, and child protective investigations just like prescribing and using any other illegal drug. 

In Canada, CBD oil is a schedule II drug, requiring a prescription.  CBD oil bought without a prescription (for example over the internet) in Canada is still illegal.

Preparations which claim to contain CBD oil may or may not contain what they claim.  In 2015 and 2016 the Food and Drug Administration (FDA) sent out a series of warning letters to companies alleging, among other things that false claims of effectiveness were being made, and that some products labeled as “CBD oil” were tested and contained no cannabidiol.  It is not unusual for products marketed as dietary supplements (as opposed to drugs) to have significant variances in their contents, but to have no CBD oil at all in a preparation is a more severe problem.

In clinical trials of adults, CBD oil has had the following adverse effects in up to 79% of participants taking the active drug:
Interactions with certain medications for epilepsy including changes in drug levels and increases in laboratory measures of liver damage.
Drowsiness
Diarrhea
Change in appetite
Fatigue
Convulsions
Lethargy
Low platelet count
Increased liver function tests (elevated in liver damage)

It is important to note that almost all of the studies of CBD oil’s adverse effects have taken place in patients with epilepsy.  Also, we don’t know whether CBD caused these effects or if they could have been due to other medications the patients were taking or due to chance.  The main issue is, we do not really have a good grasp for the side effects of CBD oil nor of its interactions with other medications, but some of the things that have been noted in clinical studies have been concerning. 

In a 76 month study of a mixed THC/CBD oil oral spray in diabetic adults, no new concerns were identified.  However, CBD oil has never been investigated for long term side effects in children.  The longest period of treatment in a clinical trial so far is 3 months in children with treatment resistant epilepsy.  Long term effects are important because children’s brains are still developing.  Because marijuana has well known negative effects on cognitive and psychological development in children, it is important to establish that CBD oil definitely does not.

Effectiveness
CBD oil has never undergone any clinical trials with respect to its effectiveness for ADHD in adults or in children.  Currently there are no clinical trials planned to examine this issue.

There are a few larger clinical trials that indicate cannabidiol may be effective for treatment resistant epilepsy.  There are many clinical trials planned and recruiting.   Cannabidiol is in stage 3 clinical trials for treatment resistant epilepsy.

There is limited clinical trial evidence that cannabidiol may be effective for anxiety.  Most of the clinical trials have involved single doses of cannabidiol and relief of anxiety over a single event such as simulated public speaking, not treatment of patients with an anxiety disorder over a period of time.   At most they are suggestive that further trials could be fruitful.  Of note, though, marijuana is known to increase anxiety over the long term and to produce anxiety as part of its withdrawal syndrome, so it is truly too soon to guess whether cannabidiol will be a good treatment for anxiety or not.

The bottom line
CBD oil currently has zero evidence for its effectiveness in treating ADHD.  The FDA is currently pursuing companies which falsely market their products as such.  CBD oil frequently has unpleasant side effects, but more serious side effects need to be more closely examined.  Its long term side effects are unstudied in children.  However, since marijuana can have significant long term side effects, such as permanent cognitive delays, more research is currently urgently needed before patients can confidently assume CBD oil is safe for use in children.  In the mean time, CBD oil is currently a schedule I drug in the United States, meaning that access will be limited and that users must be willing to take into account possible legal consequences in addition to physical side effects.

Children who have uncontrolled seizures may be able to obtain experimental treatment with CBD oil through a research study or through an expanded use agreement with the FDA.  However, the evidence that CBD oil’s benefits outweigh the risks in children with ADHD and no seizures is definitely lacking at this time.

References:

Koo, Chung Mo, and Hoon-Chul Kang. “Could Cannabidiol Be a Treatment Option for Intractable Childhood and Adolescent Epilepsy?” Journal of Epilepsy Research, vol. 7, no. 1, 2017, pp. 16–20., doi:10.14581/jer.17003.

National Institute on Drug Abuse.  “Marijuana.” NIDA, National Institutes of Health, 1 Aug. 2017, www.drugabuse.gov/publications/drugfacts/marijuana.

Soares, Vanessa P., and Alline C. Campos. “Evidences for the Anti-Panic Actions of Cannabidiol.” Current Neuropharmacology, vol. 15, no. 2, Apr. 2017, pp. 291–299., doi:10.2174/1570159x14666160509123955.

United States Food and Drug Administration. “FDA and Marijuana: Questions and Answers.”U.S. Food & Drug Adminstration, U.S. Food & Drug Adminstration, 15 Aug. 2017, www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm#legal.



2 comments:

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  2. The lack of research is mainly due to cannabis being illegal for so long and still illegal in some areas of the world. Although, more and more studies and research on cannabis and CBD are popping up all the time with its legality spreading. cbd oil blog

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