British new born first baby in world to join cannabis therapy trial
A British baby, born in March, is participating in a cannabis derived clinical trial, which appears to be a world first. The study is examining whether the medicine is safe and effective in lessening the degree of brain injury for babies with the condition neonatal hypoxic ischemic encephalopathy (HIE). It is the first step towards possible prescription of cannabis based medication to help babies that are at risk of seizures and brain damage.
In the trial, the drug is administered intravenously and the first babies to take part only receive a 30th of the usual dose. It involves other neonatal intensive care units in the UK and elsewhere in Europe and will take a year to complete.
Prof Paul Clarke, a consultant neonatologist at the Norwich hospital stated “As with any study of a new medicine there may be unexpected side effects and unknown risks. With this in mind the trial has been carefully designed to make it as safe as possible, and so we are only giving the babies a minuscule dose at the beginning, and we monitor them even more closely than usual.”
Trial Shows Promise For Enhanced Bioavailability of Oral CBD
The bioavailability of a substance refers to the amount of that substance absorbed into the bloodstream after consumption. CBD has multiple methods of ingestion and the bioavailability of each method varies. Edibles have a much lower bioavailability than inhalation due to the need for the CBD to be digested before it can enter the blood stream. This bioavailability is further decreased in patients with underlying digestive system or respiratory system issues such as IBD or Cystic Fibrosis. This concept is extremely important in the medical marijuana industry, as in order for CBD to be an effective treatment option it must be able to reach the cannabinoid receptors in the body.
Researchers at BioTeSys GmbH in Germany recently conducted the first clinical trial testing the bioavailability of oral CBD. This study looked at whether the absorption of oral CBD could be improved by using a more effective delivery system. The study involved 16 participants (8 men, 8 woman) who were each given a dose of CBD using a self-emulsifying drug delivery system (SEDDS). After 14 days the participants were given CBD diluted with medium chain triglycerides (MCT). The researchers found that the CBD blood plasma levels of those in the SEDDS group were 4.4 times higher than the MCT group suggesting a much higher bioavailability using this method. While this study had a relatively low sample size, it shows reasonably conclusive evidence in favour of SEDDS as an administration method.
Knaub K, et al. A novel self-emulsifying drug delivery system (SEDDS) based on VESIsorb® formulation technology improving the oral bioavailability of cannabidiol in healthy subjects. Molecules. 2019;24(16):2967.
CBD linked to blood pressure improvements
Hypertension affects nearly half of the US population, raising the risks of strokes and heart disease. For most people this can be controlled through lifestyle changes, medicine or a combination of both. Traditional medications for this condition are reasonably problematic with a number of significant side effects such as dehydration, shortness of breath and nausea.
In a placebo-controlled, double-blind study at the Royal Derby Hospital in the UK, oral CBD (600 mg) or a placebo (inactive substance) was administered to 26 healthy males over seven days (13 per group). The result was a significant reduction of mean arterial pressure in those treated with CBD after a single dose. This effect tapered after continued dosing across the seven days possibly due to increased tolerance, however, in response to stress, CBD was also shown to reduce systolic blood pressure with both acute and continued dosing.
This study was carried out with a reasonably small sample size, however the results suggest CBD has a positive effect on both blood pressure and arterial health. This is promising news for high blood pressure sufferers due to some of the nasty side effects caused by the current treatment options for the condition.
Sultan SR, et al. The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomized controlled trial. Br J Clin Pharmocol. 2020; in press.