The aim is to monitor the participants for the long-term and unknown side-effects of the treatment
This means that the people who participate in clinical trials that test a CBD-treatment get randomly assigned into an experimental group or a control group—one that gets the CBD-based treatment and one that gets a placebo.
CBD-study requirements vary, depending on the team behind it, but these are usually randomized clinical trials.
What Are the Phases of Cannabidiol Clinical Trials?
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Here is the overview of clinical trial phases :
Cannabidiol (CBD) has been recently covered in the media, and you may have even seen it as an add-in booster to your post-workout smoothie or morning coffee. What exactly is CBD? Why is it suddenly so popular?
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How is cannabidiol different from marijuana?
Side effects of CBD include nausea, fatigue and irritability. CBD can increase the level in your blood of the blood thinner coumadin, and it can raise levels of certain other medications in your blood by the exact same mechanism that grapefruit juice does. 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 know for 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.
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, it was able to stop them altogether. Videos of the effects of CBD on these children and their seizures are readily available on the Internet for viewing, and they are quite striking. Recently the FDA approved the first ever cannabis-derived medicine for these conditions, Epidiolex, which contains CBD.
CBD stands for cannabidiol. It is the second most prevalent of the active ingredients of cannabis (marijuana). While CBD is an essential component of medical marijuana, it is derived directly from the hemp plant, which is a cousin of the marijuana plant. While CBD is a component of marijuana (one of hundreds), by itself it does not cause a "high." 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."
Clinical trial results from Epidiolex-focused studies: The table summarizes the results from the currently completed clinical trials that have tested Epidiolex’s efficacy against various conditions. The % symptom reduction is reported as the percentage of patients in the treatment group to report improvement in the treatment of their condition. Similarly, the % of adverse effects refers to the total percentage of treatment group patients that reported any adverse effect. The sample size describes the number of patients that have completed the clinical trial currently.
The other indication awarded to GW was specific to DS, which a similar series of clinical trials were performed following preclinical research suggesting potential seizure reduction through its agonistic action on the CB1 and CB2 receptors (Anwar et al., 2019; Silvestro et al., 2019). The same titration method, dosage, and time of use was used to evaluate the safety and efficacy on patients suffering from DS; however, this study contained a smaller participant pool of 61 patients receiving the drug and 59 receiving the placebo. The patients in the treatment group reported significant reduction in the number of seizures, with over 90% of patients reporting at least a 25% reduction in frequency and nearly 5% of patients having 100% seizure reduction. Furthermore, a decrease in the average duration of the seizure was reported in tonic-clonic, tonic, clonic, atonic, myoclonic, countable, and absence seizures; however, the placebo group also reported decreases (34%) in seizure duration as well (Guy et al., 2014; Devinsky et al., 2017).
Clinical trials results from epidiolex-focused studies.
This research was funded solely through the Institute of Cannabis Research at Colorado State University – Pueblo.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
CBD has also been examined as a potential treatment for cognitive dysfunction in schizophrenic patients. A single clinical study on CBD’s effects on schizophrenia has been completed by Dr. Mohini Ranganathan from Yale University in 2013. This was a 6-week, randomized, placebo-controlled, parallel group, fixed-dose study of oral CBD (600 mg/day) in 36 stable antipsychotic-treated patients diagnosed with chronic schizophrenia. There was a significant decrease in the total score of the Positive and Negative Syndrome Scale (PANSS), which suggests a decrease in overall symptoms; however, there was no significant drug × time interaction, which means the effect of treatment did not depend on time. Conversely, in their secondary outcome measurement, there was no significant effect on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery composite score, which evaluates key cognitive functions in schizophrenic patients, but there was a significant drug × time interaction. There were no serious adverse side effects observed in this study, and the only side effect observed in the CBD group compared to the placebo was sedation (Boggs et al., 2018).
While the study designs are inconsistent, the drug and dosage being examined also varies significantly between studies. While Epidiolex has a concentration of 100 mg/ml and a maximum recommended dose of 20 mg/kg/day, some studies examined drastically deviated from that recommendation (GW Biosciences, 2018). The study performed to examine CBD’s efficacy on UC patients used 1–5 50 mg capsules; whereas, the dosage ranged from 400 mg to 800 mg doses in studies for drug-cessation (Hurd, 2013; Hill, 2016; Irving et al., 2018). This could explain the differences in the side effects of each study; however, further work is needed to conclude if the variance was due to CBD concentration or delivery method. Other studies, such as the Yale’s study into cognitive decline used a fixed-dose of 600 mg of “active cannabidiol”, but did not specify delivery mechanism in their clinical trial results, which makes it difficult to compare the results to other clinical trials (Boggs et al., 2018). Along this note, it should be required to describe in detail how the dose was given since some studies had specified they increasingly titrated the dose of CBD, which allows the patient to build a tolerance to the drug before receiving the maximum dose (GW Biosciences, 2018).