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cbd oil clinical trials

There are many claims about the beneficial use of medicinal cannabis products for a wide range of conditions. Most of these claims lack solid scientific backing, because cannabis is an illegal drug and it has been difficult for researchers to run research trials.

Participants in clinical trials for medicinal cannabis will use pharmaceutical medicinal cannabis products approved by the Therapeutic Goods Administration (TGA) and the relevant Human Research Ethics Committee (HREC).

Clinical trials are research investigations in which people volunteer to test new medications and treatments as a means to manage various medical conditions.

Research on medicinal cannabis

The 2 main active components that are the current focus of research are tetrahydrocannabinol (THC) and cannabidiol (CBD). However, there are many other components that may be beneficial and will be the focus of research in the future.

There are different types of cannabis, and these can contain over 400 various compounds in the raw form. We need to research cannabis products using known stable active components, so that treatment outcomes can be compared and replicated.

Commonwealth approval

The current research aims to establish which cannabis compounds and dosage levels are effective, and for which conditions and symptoms.

The results of ongoing clinical trials will establish an evidence base for medicinal cannabis and inform future treatment decisions.

Cbd oil clinical trials

Outside of the US, the prescription drug Sativex, which uses CBD as an active ingredient, is approved for muscle spasticity associated with multiple sclerosis and for cancer pain. Within the US, Epidiolex is approved for certain types of epilepsy and tuberous sclerosis.

Some CBD manufacturers have come under government scrutiny for wild, indefensible claims, such that CBD is a cure-all for cancer or COVID-19, which it is not. We need more research but CBD may prove to be a helpful, relatively non-toxic option for managing anxiety, insomnia, and chronic pain. Without sufficient high-quality evidence in human studies, we can’t pinpoint effective doses, and because CBD currently is typically available as an unregulated supplement, it’s hard to know exactly what you are getting.

CBD is readily obtainable in most parts of the United States, though its exact legal status has been in flux. All 50 states have laws legalizing CBD with varying degrees of restriction. In December 2015, the FDA eased the regulatory requirements to allow researchers to conduct CBD trials. In 2018, the Farm Bill made hemp legal in the United States, making it virtually impossible to keep CBD illegal – that would be like making oranges legal, but keeping orange juice illegal.

The Farm Bill removed all hemp-derived products, including CBD, from the Controlled Substances Act, which criminalizes the possession of drugs. In essence, this means that CBD is legal if it comes from hemp, but not if it comes from cannabis (marijuana) – even though it is the exact same molecule. Currently, many people obtain CBD online without a medical marijuana license, which is legal in most states.

How can CBD be taken?

CBD, or cannabidiol, is the second most prevalent active ingredient in cannabis (marijuana). While CBD is an essential component of medical marijuana, it is derived directly from the hemp plant, a cousin of marijuana, or manufactured in a laboratory. One of hundreds of components in marijuana, CBD does not cause a “high” by itself. According to a report from the World Health Organization, “In humans, CBD exhibits no effects indicative of any abuse or dependence potential…. To date, there is no evidence of public health related problems associated with the use of pure CBD.”

A significant safety concern with CBD is that it is primarily marketed and sold as a supplement, not a medication. Currently, the FDA does not regulate the safety and purity of dietary supplements. So, you cannot be sure that the product you buy has active ingredients at the dose listed on the label. In addition, the product may contain other unknown elements. We also don’t know the most effective therapeutic dose of CBD for any particular medical condition.

Animal studies, and self-reports or research in humans, suggest CBD may also help with:

Is CBD safe?

CBD has been touted for a wide variety of health issues, but the strongest scientific evidence is for its effectiveness in treating some of the cruelest childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome (LGS), which typically don’t respond to antiseizure medications. In numerous studies, CBD was able to reduce the number of seizures, and, in some cases, stop them altogether. Epidiolex, which contains CBD, is the first cannabis-derived medicine approved by the FDA for these conditions.

Cannabidiol (CBD) is often covered in the media, and you may see it touted as an add-in booster to your post-workout smoothie or morning coffee. You can even buy a CBD-infused sports bra. But what exactly is CBD? And why is it so popular?

Cbd oil clinical trials

Single-site, randomized, placebo-controlled, cross-over, within-subjects design.

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Study sessions are 72 hours apart. Visits included pre-post assessments following ingestion of either placebo or CBD.

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Resource links provided by the National Library of Medicine