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COVID-19 and Cannabidiol (CBD) US National Institute on Drug Abuse, NIH; Medical Consequences of Drug Abuse and Infections Branch, National Institute on Drug Abuse, NIH, Bethesda, Maryland (JHK); It’s too early to tell whether CBD helps against Covid-19 — but researchers worry that won’t stop CBD makers. COVID-19 pandemic has resulted in devastating mortality and morbidity consisting of socioeconomic and health effects that have included respiratory/pulmonary, cardiovascular, mental health and neurological consequences such as anxiety, depression, and substance use. Extensive efforts are underway to …

COVID-19 and Cannabidiol (CBD)

US National Institute on Drug Abuse, NIH; Medical Consequences of Drug Abuse and Infections Branch, National Institute on Drug Abuse, NIH, Bethesda, Maryland (JHK); Samaritan Daytop Village Treatment Center and NYU Medical School, New York (GB); Microbiology, Immunology, and Tropical Medicine, George Washington University School of Medicine and Health Sciences, Washington, DC (SBM); Institute of Human Virology University of Maryland School of Medicine, Baltimore, Maryland (SK).

Send correspondence to Jag H. Khalsa, MS, PhD, 24924 McNair Place, ALDIE, VA 20105-5572. E-mail: [email protected]; [email protected]; [email protected]

This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

Abstract

COVID-19 pandemic has resulted in devastating mortality and morbidity consisting of socioeconomic and health effects that have included respiratory/pulmonary, cardiovascular, mental health and neurological consequences such as anxiety, depression, and substance use. Extensive efforts are underway to develop preventive vaccines and therapeutics such as remdesivir, dexamethasone, convalescent plasma, and others to treat COVID-19 but many report residual mental health problems after recovery. Cannabis products such as cannabidiol (CBD) are being advertised for the treatment of COVID-19 associated mental health problems and substance use disorders. This commentary will briefly clear the myth that CBD can ameliorate a wide range of COVID-19 associated health effects including anxiety, depression, or any substance use disorder, and show that there is a clear lack of sufficient unbiased clinical evidence from well-designed double-blind, placebo-controlled clinical trials to prove the antianxiety or antidepression therapeutic properties of CBD and support its wide use as medicine to treat COVID-19- associated mental health conditions or substance use disorders. Finally, we suggest that addiction physicians must play an important role in dealing with their patients requesting CBD prescription for treating any of these conditions.

Today, the world is facing one of the most devastating viral pandemics of our time where almost 62 million people have been infected with a novel corona virus, known as severe acute respiratory syndrome cornonavirus-2 (SARS-Cov2), and more than one million people have died from the corona virus induced disease (COVID-19). 1 The COVID-19 pandemic is also responsible for unprecedented loss of life, economic, social, and health consequences including severe acute respiratory syndrome (SARS), 2 cardiovascular, 3 mental health including anxiety, depression, and neurological complications like tremors, seizures, and impaired consciousness. 4 An estimated 45% of adults in the US reported that their mental health has been negatively impacted due to worry and stress over the virus. 5 Further, people with preexisting health conditions including asthma, cerebrovascular disease, hypertension, diabetes, immunocompromised state, neurological conditions such as dementia and others might be at increased risk from COVID-19. 6 The conditions such as imposed shelter-in-place, physical distancing, social isolation and potential financial distress from job loss might further lead to mental health problems, increased substance use, and possibly suicides. Furthermore, limited access to mental health care and addiction treatment health care providers for treating substance use disorder(s) may also in part exacerbate COVID-19 related complications, thereby necessitating the use of telemedicine to treat people with substance use disorder(s).

Extensive efforts worldwide are underway to develop vaccines and therapeutics including remdesivir, dexamethasone, and convalescent plasma to combat the coronavirus induced symptomatic disease (COVID-19) and associated complications. Even though long-term use of cannabis is associated with significant morbidity including increased risk of panic attacks, 7 the internet is filled with suggestions for using cannabis or cannabinoids including cannabidiol (CBD) for the treatment of coronavirus infection induced inflammation and COVID-19 induced mental health conditions including anxiety, depression, PTSD, and panic attacks. The recent changes in legalization of CBD in many US states have made CBD products easily accessible to all as over the counter products. This commentary will briefly show that the use of CBD for the treatment of anxiety, depression and substance use disorder(s) are just myths and not a reality.

Though CBD may be a promising drug to treat panic disorders, generalized anxiety disorder, post-traumatic disorder (PTSD), social anxiety disorder, and depressive disorders 8 via serotonergic pathways and endocannabinoid system, extensive literature search failed to find sufficient clinical evidence to support CBD for treating any of the above-mentioned mental conditions. 9 Much more clinical research from well-designed clinical trials is needed to support the use of CBD in treating anxiety and depressive disorders and bipolar disorders. 10 CBD may promote wakefulness via triggering increased dopamine levels in areas of the brain and thereby treat narcolepsy, and in a case report, 11 CBD did improve the quality and quantity of sleep of a 10-year old young patient with PTSD, likely due to its anxiety-relieving benefits. But these data from one patient are clearly insufficient to support the use of CBD for treating sleep disorders.

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Could CBD treat substance use disorders? The answer is not yet. Limited research suggests that CBD could potentially treat patients with substance use disorders like opioid-, cannabis-, and tobacco use disorders (OUD, CUD, TUD). 12 Earlier studies showed that legalization of medical marijuana reduced the number of over dose deaths from opioid pain relievers, 13 and that medical marijuana laws significantly reduced prescribing of opioids for pain. 14 More recently, Hurd et al 15 reported that acute administration of CBD to heroin abstinent patients with OUD significantly reduced craving, anxiety, heart rate and salivary cortisol without causing adverse effects. But still additional clinical trials are needed to establish the efficacy of CBD in treating opioid use disorder. 16 In a randomized, double blind, placebo-controlled trial, 17 nabiximols (THC+CBD [Sativex]) combined with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), reduced cannabis use and craving but not withdrawal symptoms in persons that used cannabis chronically. CBD also reduced euphoria and depressive and psychotic-like symptoms, improved attention, verbal learning and memory without impairing cognition when smoking cannabis, suggesting that prolonged therapy with CBD may be a useful adjunct therapy for treating cannabis dependence. 18 In a study of 24 tobacco smokers, CBD inhaler reduced the number of tobacco cigarettes by 40% when compared to placebo 19 ; and a single dose of 800 mg oral dose of CBD reduced the salience and pleasantness of cigarette cues, but did not influence tobacco craving or withdrawal or any subjectively rated side effects. 20 Data from these studies with a small number of patients present a positive signal of CBD’s potential to treat substance use disorders, but significantly much more research from well-designed clinical trials is needed to support its wide use as treatment for substance use disorder(s).

Thus, there is a clear paucity of data from well-designed clinical trials to support the use of CBD for treating anxiety, depression, other neurological complications associated with COVID-19 or substance use disorders. A careful systematic evaluation of CBD in large clinical trials is essential prior to endorsing its wider use for alleviation of mental health symptomatology. It is also of paramount importance that the clinicians treating patients with any of the above COVID-19 related mental or neurological conditions or substance use disorders inform their patients about the lack of sufficient unbiased clinical evidence for the use of CBD and discourage them from using CBD for COVID-19 related health problems during this COVID-19 related severe, unprecedented global health catastrophe.

Acknowledgments

The primary author is grateful to the US National Institute on Drug Abuse, a component of the National Institutes of Health, Department of Health and Human Services, for an opportunity to serve as a Special Volunteer following his retirement on October 31, 2017 after 30+ years as the Chief, Medical Consequences of Drug Abuse and Infections Branch.

It’s too early to tell whether CBD helps against Covid-19 — but researchers worry that won’t stop CBD makers

T he scientists stressed the caveats that early-stage research demands: the compounds they had studied showed hints — in cells in lab dishes and in animals — of being able to combat the coronavirus. Definite answers could only come from clinical trials.

But the compounds were CBD and other marijuana and hemp derivatives, so the news took off. Kimmel and Colbert cracked jokes. The studies received coverage in outlets from Fox News to The Daily Beast.

The latest hubbub is an example of both the promise of cannabinoids — components of cannabis — as potential therapies, but also the hype around them, which can far outpace the evidence that they work. It’s left researchers and consumer advocates scrambling to warn people that patients shouldn’t be turning to over-the-counter products or recreational marijuana in hopes that it might protect them from Covid-19.

“We don’t want people running out taking random cannabinoids,” said Marsha Rosner of the University of Chicago, the senior author of one of the new studies.

The research also presents a new challenge for the Food and Drug Administration, which is already struggling to police the rapidly growing CBD market. While the agency has said CBD makers can’t market their products as medical treatments without conducting a clinical trial and submitting an application to the agency, few companies have actually invested in conducting those trials. Instead, companies have tried to tiptoe around the FDA rules by selling their products as dietary supplements and making only modest claims. Experts fear that the FDA’s job will only get harder with the increased hype around cannabinoids and Covid-19.

“These kinds of studies are what these companies look for to promote their products — that’s the scary part,” said Jeanette Contreras, director of health policy at the National Consumers League, which runs a campaign called Consumers for Safe CBD. “This gives them more fuel to make false claims about their products.”

Related: The FDA is finalizing its long-awaited rules for CBD

R osner and her team were initially skeptical that CBD could have any potential effect for Covid-19. They thought that if there was going to be any benefit, it might be in the late-stage illness that occurs when the immune response to the virus goes into hyperdrive.

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But then they found something that surprised them: While CBD couldn’t block the virus from entering human epithelial cells in lab dishes, it prevented the pathogen from hijacking the cell’s internal Xerox machines to make copies of itself. It also lowered viral levels in infected mice.

Rosner and her team’s paper was published in Science Advances this month, soon after researchers in Oregon reported in the Journal of Natural Products that two chemicals found in hemp, CBGA and CBDA, could bind to the virus’ spike protein and thus prevent it from infecting cells in lab dishes.

Together, the two studies earned attention for the suggestion that cannabinoids might have a role to play in the pandemic.

But since the work was published, Rosner has been trying to inject caveats and nuances into the discussion around CBD for Covid.

As she emphasizes: experiments in mice and cells in lab dishes regularly seem like breakthroughs, whether for Covid-19 or just about any other ailment. But only rarely do they go on to demonstrate any actual effectiveness in human trials.

Outside researchers also noted that the two papers reported sometimes opposing results for how cannabinoids interacted with the coronavirus, indicating that any potential effect needs to be further studied.

“These are the seeds of our knowledge related to how cannabinoids might interact with the SARS-Cov-2 virus,” said Ziva Cooper, the director of the UCLA Cannabis Research Initiative. “We have a long way to go.”

Related: A spate of new class-action lawsuits threaten the CBD industry. Will they force Washington to act?

T he new studies are adding to the FDA’s existing CBD headache, too.

The agency has already grappled with companies trying to use early research into CBD and Covid-19 to promote their products — it has sent 13 official warning letters demanding that companies stop selling their CBD products as Covid-19 treatments.

Some of those companies did not explicitly call their products cures, but instead included outside research on their websites that could lead consumers to believe CBD was a proven treatment for Covid-19, STAT found when it reviewed the FDA’s warning letters. Other companies explicitly noted that their product was not a treatment for Covid-19 but suggested, for example, that “ the best thing you can do is boost your immune system.”

This has been a long-running issue with CBD, which the FDA regulates the same way it does other prescription drugs. That means anything with CBD in it must go through the agency’s rigorous approval process if companies want to suggest it can treat or cure anything at all.

Few companies have been willing to invest the time and effort needed to actually get a CBD drug through the regulatory odyssey. Instead, most market their products as dietary supplements in hopes that the FDA will not crack down on their individual products.

Related: The company behind the first-ever CBD-based drug is now eyeing everything from multiple sclerosis to autism

Research is hard for other reasons, too. Just a few years ago, researching cannabidiol was heavily restricted because of marijauna’s legal status, and the trials are still hard to conduct — one researcher called the system a “nightmare.”

That means there’s hardly any infrastructure or investment into actually testing whether CBD has an impact on Covid-19.

In fact, there’s still not much late-stage clinical research into whether CBD really does much of anything at all.

“The status quo is challenging,” said Lowell Schiller, the former co-lead of the FDA’s CBD working group. “When we see potentially promising research coming out of the laboratory setting, where are the dollars coming from to do the kind of rigorous clinical research that we need to genuinely understand whether there’s a there there ?”

It’s an open question whether new trials looking at cannabinoids and Covid will take off. Scientists have hypothesized that CBD or other cannabinoids might have some role to play against Covid-19 for much of the pandemic, but a STAT review of clinicaltrials.gov identified just seven trials that have tested CBD as a therapy for Covid-19, the majority of which are early-stage studies that would not produce the type of results necessary to conclude whether CBD can help combat the pandemic.

Rosner said she and her colleagues have been in touch with various companies about clinical trials, but so far, nothing’s set up. “Our hope is we can get some traction in the near future,” she said.

Related: These four companies are betting big on CBD-based prescription drugs

Richard van Breemen, a professor of medicinal chemistry at Oregon State University and one of the scientists involved with the other paper, told the Boston Globe this month that he expected data from clinical trials later this year. He did not respond to a question from STAT about whether clinical trials based on his team’s research had started or when they might.

Not all clinical trials are created equally, either — a fact that has dogged scientists’ efforts to test potential Covid-19 treatments. Going back to the heady days of hydroxychloroquine mania, dozens of trials of different treatments were launched based on preclinical hope, but they were ultimately too small or too poorly designed to come up with definite answers. The pileup of unhelpful U.S. clinical trials stands in stark contrast to something like the Recovery trial out of the United Kingdom, where a cohesive strategy and a national health system led to clear findings about treatments like dexamethasone (which worked) and convalescent plasma (which didn’t).

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“It’s not just, is there a clinical trial, but what kind of clinical trial?” Rosner said, adding that her team was hoping to conduct a rigorous trial.

Trending Now: Complexity of Covid vaccine program leads to concerns about potential for error

In the meantime: Rosner is urging consumers not to go buy CBD to try to prevent Covid-19. For one, it’s not clear the products available at convenience stories contain pure CBD, or at what levels. The clinical trial Rosner envisions would test a pharmaceutical-grade CBD — something like the FDA-approved Epidiolex, an epilepsy treatment.

There’s another reason why people shouldn’t smoke marijuana or pop an edible and think it might be helping protect them from Covid-19, Rosner added: While her team reported an effect from CBD, the scientists found that the added presence of THC — the component of marijuana that makes people high — counteracted whatever benefits CBD may provide.

“The last thing we would like to see is for someone to say, ‘I’m going to go out and take CBD,’ and say, ‘I’m not going to get vaccinated, I’m not going to get boosted, I’m going to take off my mask,’” she said.

COVID-19 and Cannabidiol (CBD)

COVID-19 pandemic has resulted in devastating mortality and morbidity consisting of socioeconomic and health effects that have included respiratory/pulmonary, cardiovascular, mental health and neurological consequences such as anxiety, depression, and substance use. Extensive efforts are underway to develop preventive vaccines and therapeutics such as remdesivir, dexamethasone, convalescent plasma, and others to treat COVID-19 but many report residual mental health problems after recovery. Cannabis products such as cannabidiol (CBD) are being advertised for the treatment of COVID-19 associated mental health problems and substance use disorders. This commentary will briefly clear the myth that CBD can ameliorate a wide range of COVID-19 associated health effects including anxiety, depression, or any substance use disorder, and show that there is a clear lack of sufficient unbiased clinical evidence from well-designed double-blind, placebo-controlled clinical trials to prove the antianxiety or antidepression therapeutic properties of CBD and support its wide use as medicine to treat COVID-19- associated mental health conditions or substance use disorders. Finally, we suggest that addiction physicians must play an important role in dealing with their patients requesting CBD prescription for treating any of these conditions.

Copyright © 2020 American Society of Addiction Medicine.

Conflict of interest statement

Research grants to the institution from Merck, Inc., Gillead Sciences, and Airbutus pharmaceuticals. Other authors report no conflicts of interest.

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