The possible therapeutic benefits of cannabidiol, also known as CBD, hold a lot of promise. As more and more users report experiencing positive benefits, researchers have realized the real need for additional studies on CBD. Previously confined to small-scale studies or studies performed on rodents, some of these up-and-coming studies have even expanded to include significant double-blind clinical trials. The world of CBD research is an exciting place to be, as new developments come out on a daily basis. Because the world of CBD is rapidly changing, we wanted to explore the current state of CBD research and how it impacts you as the user. In this guide, we’ll discuss:
- What Research Currently Exists Around CBD?
- Why Are Further CBD Clinical Trials Important?
- FDA Stance on CBD Research
- CBD Research? There’s an App for That
- Double-Blind Placebo Controlled Trials
- New and Upcoming Studies
- More Info on CBD Research
CBD research is only in its infancy. CBD has recently entered the medical arena, and there are still many unanswered questions to be explored. Early research on CBD focused on differentiating between the different cannabinoids in cannabis, namely THC and CBD. CBD was found to be non-psychoactive, and some researchers found that it may hold potential therapeutic properties. Next, researchers looked at the effects of CBD on epilepsy. However, the research wasn’t taken seriously.
It was only once researchers discovered how our body’s endocannabinoid system (ECS), a network of receptors, interacts with receptors found in cannabinoids that interest in the substance began to explode.
Over the past few years since that initial discovery, researchers have launched a few small-scale CBD studies and CBD clinical trials to uncover potential benefits for the compound. CBD is being utilized by consumers who are seeking alternative treatment options for a variety of mood disorders, including anxiety, PTSD, and depression. It has also been reported that it may help to reduce sensations of pain among chronic pain sufferers. In 2018, the FDA approved the first-ever drug to contain CBD, an epilepsy treatment called Epidiolex.
There is still much to learn about CBD. No long-term clinical trial has studied the effects of CBD and any potential side effects. It will be quite some time before a multi-decade, longitudinal CBD clinical study is completed.
Relatively speaking, we know practically nothing about the potential applications of CBD in modern medicine. Much of the data that exists is from small-scale studies or studies performed on rodents. However, CBD does show potential. Users have reported experiencing a plethora of benefits, and some have found that taking CBD greatly improves their quality of life. Research has yet to catch up with the consensus of users.
CBD may be useful for a wide range of conditions, but we won’t know without thorough investigation. The better physicians understand how CBD affects the human body, the easier it is for them to prescribe effective and safe doses. Further CBD clinical trials are needed to gain a full and complete understanding of CBD and how it affects each individual health situation.
Currently, the FDA has only approved one CBD product, a prescription drug designed to treat two rare forms of epilepsy. It is currently illegal to market CBD by labeling it as a dietary supplement. However, this presents a problem as some CBD products are being marketed to consumers with unproven claims and with their quality and potency virtually unknown. The FDA needs much more research and information before it can begin to monitor and regulate CBD on the market effectively.
This commitment to research is part of the ongoing FDA Over-the-Counter (OTC) Monograph review process, a set of rules laid down by the Food and Drug Administration, which helps regulate the safety and efficacy of over-the-counter (OTC) pharmaceutical agents, which includes everything from Tylenol to Sudafed at the local drugstore. These rules dictate how these types of drugs can be manufactured and sold and how to appropriately label them. Obviously, this is all done to help protect the consumer and guide the professionals who may recommend various over-the-counter treatment options for patients.
The FDA has only limited data on CBD safety, and they would like to see more data on:
- How much CBD is safe to consume daily?
- Does the dose vary depending on what form is taken?
- What are the impacts on specific populations, such as children, the elderly, and pregnant women?
- What are the risks of long-term exposure?
Additionally, the FDA has pointed out some serious areas of potential risk in a recent congressional testimony. Some of potential concerns include:
- Liver injury. During its review of Epidiolex, the FDA identified the risk for potential liver injury. This risk can be managed when the drug is taken under medical supervision, but it isn’t clear how it may be managed when CBD is used without medical supervision. Liver injury was also shown in a 2019 study performed on rodents, but only in significant doses.
- Drug interactions. There is also a risk of CBD impacting other medicines a consumer takes. Other medications may also impact the dose of CBD that can safely be used. Taking CBD with other medications may increase or decrease the effects of those medications. Doing so also can cause an increased risk of side effects from the other medications, which is especially concerning for those who rely on prescription medications for treating or managing the symptoms of serious or chronic health conditions. It’s also not known how CBD may interact with many herbal supplements and vitamins. Taking multiple medications or supplements can be dangerous when not done under the supervision of a medical professional.
- Male reproductive toxicity. Another study on CBD in 2018 also showed that CBD may cause male reproductive toxicity, including the male offspring of CBD-treated pregnant females. Potential negative effects include decreased testicular size, inhibited sperm development, and decreased testosterone. These findings were only seen in rodents, so it isn’t clear how they impact humans. However, it’s clear that more research needs to be conducted in this area.
As explained above, the FDA must have significant real-world data on the possible link between CBD and liver toxicity data before it can begin regulating CBD. That’s why a cannabis-focused health and wellness research company, ValidCare, created an app called CBD+me. It allows users to track the effects they experience with CBD, providing them with insight into how their mind and body are responding to CBD products. Additionally, the users could opt in to participate in a study that aggregates that data and compiles it for the FDA.
A 2016 law, called the 21st Century Cures Act, allows for data collection from study participants to come in through mobile devices. The CBD+me app is the first in the hemp space using data collection via mobile devices. Additionally, it helps overcome a lot of the hurdles associated with CBD research, one main one being funding. “No one has $50 million to do a study. It’s not realistic,” McCarthy told Hemp Industry Daily. The app allows for low-cost data collection.
In mid-November 2019, ValidCare took a look at the data collected in the initial study and compiled into a white paper to present to the FDA, finding:
- More than 2,000 registered users, with ages ranging from 19 to 82
- 69% of users preferred a full-spectrum product over an isolate product
- About half of users were taking between 25-30 milligrams of CBD per day
- More than 85% preferred oral consumption
- Less than 5% reported a side effect, with effects including sore throat, digestive issues, and confusion
- More than 70% reported positive progress toward their goals for taking the product
One of the most exciting development in CBD research is the development of double-blind, placebo-controlled trials. Up until recently, most of the studies performed on CBD have been limited to either in-vitro or animal (rodent) studies or were small-scale or open-label trials on humans. In open-label trials, both the patient and their physician know they’re using the experimental drug. This allows for bias because the expectation can actually influence outcomes, a common problem among open-label studies known as the placebo effect. This bias poses limitations to the studies and has slowed down the clinical use of CBD, even in cases where the pre-clinical evidence is overwhelming.
On the other hand, a double-blind, placebo-controlled study reduces the risk of bias. In this type of study, neither the patient nor their physician knows whether the treatment the patient receives is a placebo or CBD. By moving towards double-blind, placebo-controlled trials, CBD research will begin to get more respect from the medical community. Promising studies may actually begin to invoke real change in pharmacological treatment strategies.
At the end of 2019, several double-blind, placebo-controlled CBD trials were published:
- CBD and TMD. A study in Poland found that CBD helped relax jaw muscles and reduce pain when applied topically twice daily among study participants. The pain users typically felt resulted from muscle damage due to excessive clenching, and CBD provided localized muscle relaxation and pain relief in a non-addictive method in this trial.
- CBD and peripheral nerve damage. Another study conducted in December of 2019 also studied the effect of topical CBD on pain management, and in particular, peripheral nerve damage. Peripheral nerve damage is caused by damage to nerves that causes them to send signals to the brain that is interpreted as pain. When CBD was applied topically to the painful site, it helped reduced the amount of pain the patients felt as well as the ice/cold feelings also associated with the disease. Additionally, no adverse effects were reported in this particular study.
- CBD and anxiety. In a study conducted in November 2019, CBD was tested on teenagers with social anxiety disorder (SAD). Participants who took 300mg of CBD daily for four weeks showed improved indicators of social anxiety compared to participants who took placebo pills. This study indicates that CBD may be an effective treatment for social anxiety in young adults.
There are quite a few studies that are right at the forefront of CBD research. Most of this research is driven by pharmaceutical companies who are looking to develop new CBD-based medications. Here is the latest news:
- CBD and muscle spasticity. GW Pharmaceuticals recently reacquired their rights to Sativex, a CBD-based drug for muscle spasticity brought on by Multiple Sclerosis (MS). Due to inflammation of the nerves caused by MS, patients may experience stiffness or numbness in the legs, which is known as muscle spasticity. Studies have shown that CBD may reduce the inflammation caused by MS and may even prevent long-term nerve damage. A CBD-based treatment could potentially be combined with current medications and physical therapy to help provide sufferers of the disease with a well-rounded treatment approach. GW Pharmaceuticals created Sativex as an oral spray to provide a quick and easy application for patients dealing with muscle spasticity. The drug needs to clear Phase 3 of testing before the pharmaceutical company can submit the drug for approval in the United States, which means, as you may have guessed, more testing.
- CBD and ALS. CannTrust, one of Canada’s biggest producers of cannabis, has partnered with Australia’s Gold Coast University Hospital to conduct a study to determine if CBD can slow the progression of Amyotrophic Lateral Sclerosis (ALS). ALS is a form of scoliosis, which causes degeneration of the lateral area of a patient’s spinal cord. This CBD research is aimed at better understanding the disease and possibly slowing its progression. Dr. Sabet, a senior specialist with the hospital, will be leading the six-month study, investigating the effects of CBD on ALS.
- CBD vs. fentanyl. Santѐ Cannabis, an independent cannabis research organization, is partnering with Tetra Bio-Pharma, Inc. to conduct a study comparing the effects of CBD oil to fentanyl. Fentanyl is an opiate that helps relieve ongoing pain and is more than fifty times more potent than morphine. It is also highly addictive and poses a high risk of overdose. This study will address how well CBD can relieve pain and what role the presence of THC concentrations has on providing relief. Current studies show that CBD oil may greatly reduce chronic pain, without the risk of addictive side effects.
- CBD and the flow state. Ojai Energetics has partnered with The Flow Research Collective to examine the effects of CBD on the amount of time it takes to enter into the flow state, the depth of flow experienced, and recovery. Musicians and other creatives experience a state of “flow” where dopamine, serotonin, and endorphins provide a natural high and an ideal state of performance. Users of CBD have also reported this same feeling, so researchers are looking into the effects of CBD on humans’ ability to achieve the flow state.
Check out these articles for more information on the latest trends in CBD research:
- CBD & Cannabis Statistics
- A Guide to Cannabidiol (CBD) Clinical Trials
- CBD 2020 Outlook: How the Cannabidiol Forecast Looks in the New Decade
- The CBD Market Consumer Research: A Guide to Become a Smart Consumer
- Top 2020 CBD Company Research and Best Products Review Guide
- CBD Clinical Trials
- 50 Intriguing CBD Clinical Trials to Watch