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Cannabinoid clinical trials – where, what and how?

An expert explains everything you need to know about the clinical trials taking place on cannabinoids.

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cannabinoid clinical trials
More than 450 clinical trials on cannabinoids have taken place or are currently underway

More than 450 cannabinoid clinical trials have taken place or are currently underway, Miguel Fagundes, chief technical officer at Eurocan explains everything you need to know about these studies.

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The rapid growth of cannabis-based medicines is creating significant disruption within the global pharmaceutical industry and changing the way the pharmaceutical industry approaches cannabis, as pharmaceutical cannabis products are becoming genuine alternatives to traditional pharmaceuticals for certain treatments, conditions and diseases.

Clinical trials and academic studies are increasing around the world constantly thereby increa

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sing our understanding of the properties of cannabis plant.

Where?

Cannabinoid related trials and studies are taking place all around the world. Most ongoing or upcoming clinical trials are taking place in the US where the large population pool, a developed network of experienced investigators, a supportive regulatory framework, and a vast market of drug consumption all combine to support expansion in clinical trials.

The UK and the Netherlands are currently responsible for around 71 percent of the active cannabinoids clinical trials in Europe, a reflection of the fact these countries were among the first movers in easing the regulatory and legal barriers to commercial research and clinical trials. Elsewhere, Israel also has a significant role in cannabis related research with involvement in over 20 active/completed clinical trials.

What?

Over 250 clinical trials have already been completed and there are more than 200 active clinical trials in process around the world.*

cannabinoid trials graphic

Interventional Studies: 

This type of study dictates that the participants are assigned into groups that receive one or more intervention/treatment (or no intervention) so the effects on biomedical or

health-related outcomes can be evaluated by researchers. 

Observational Studies: 

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Participants belong to study groups and are assessed for biomedical or health outcomes.

The investigator does not assign participants to a specific intervention/treatment.

The majority of on-going cannabinoids-related studies are “interventional” in nature (over 90 percent), in line with regulators’ preference that evidence be obtained in a controlled manner,  with participant groups monitored in a controlled environment.  Recent information shows that a large number of trials are actively recruiting, in addition to those which have already been completed.  This indicates the scientific and medical commitment to continue to move forward with the clinical research to prove clinical relevance and therapeutic potential of these cannabinoid molecules.


Study design

Clinical trials in relation to cannabinoids are generally (72 percent) designed so as to ensure a random allocation of intervention/treatment among the trial participants. A typical study design will include placebo-controlled, randomised, single-ascending dose and multiple- ascending dose studies. This structured and standardised approach produces effective and reliable scientific evidence on the effectiveness and safety of cannabinoids, without bias.

Purpose of trials

The main purpose of current clinical trials into cannabinoids is to search for new treatments and to collect scientific data. The scientific data obtained through clinical trials explains how cannabinoids interact with receptors within the human body. Clinical trials also assist in  understanding the physiological responses by participants during trials.

cannabinoid trials

How?

​​The main sources of funding clinical trials and studies are academic research institutions, private enterprises and national governments. Each of these are key players in the process of adoption and access to cannabinoids for end-users. Most studies to date have been funded by academic institutions, but in recent times there has been a significant increase in the number of joint ventures and research projects with private enterprises. A significant proportion (roughly 20%) of studies are entirely privately funded, with only a small proportion being funded by governments.

cannabinoid trials

Conclusion

More than 450 clinical trials studying cannabinoids as potential drugs with clear therapeutic application have been completed or are in progress. Minor cannabinoids are also gaining attention within the research community and this will further broaden our knowledge of the full properties of the cannabis plant.

It is clear that this level of interest and the increasing knowledge base surrounding the endocannabinoid system, cannabinoids and cannabis-based medicines have the potential to change the way we medicate in future years. The commitment to scientifically robust evidence and data driven product development within the cannabis industry will only benefit end users and assist in the growth of a regulated market to develop new and innovative products.

Read more: The clinical trials roadmap: Everything you need to know about the trialing of new medicines

READ MORE  Canadian doctors ‘still reluctant’ to prescribe medical cannabis

* Publicly availing information regarding clinical trials is available at clincaltrials.gov, clinicaltrialsregister.eu and health-products.canada.ca.

References: Clinicaltrialsregister.eu / Clinicaltrials.gov  / WHO /  INFARMED / NICE

info@euro-can.eu  /  www.euro-can.eu

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Industry

Cannabis legalisation not linked to rise in car accidents, says study

Cannabis legalisation sparked fears that it would increase driving-related emergency rooms admission

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cannabis legalisation car accidents

A team of researchers have studied emergency room records and determined that cannabis legalisation in Canada has not resulted in an increase in admissions.

The data published in the journal of Drug and Alcohol Dependence revealed that there has been no increase in two provinces, Alberta and Ontario.

Canada legalised cannabis in 2018, which led to concerns that it would increase the number of traffic injuries, especially among young drivers.

The researchers, from the Centre for Addiction and Mental Health and the University of British Columbia, assessed emergency department records to find any patterns in traffic-injury visits in the months leading to the legalisation and immediately afterwards.

They separated the drivers into two groups focusing on adult drivers and teenagers aged 14 to 18-years-old.

Cannabis legalisation and drivers

They reported: “The current study found no evidence that the implementation of the Cannabis Act was associated with significant changes in post-legalisation patterns of all drivers’ traffic-injury ED visits or, more specifically, youth-driver traffic-injury ED presentations.”

“Given that Canada’s Cannabis Act mandated that the Canadian Parliament review the public health consequences of the Act no later than 2023, the findings of the current study can provide empirical data not only for the Canadian evaluation of the calculus of harms and benefits but also for other international jurisdictions weighing the merits and drawbacks of cannabis legalisation policies.”

The Canadian data is consistent with studies from the United States that show no changes in traffic safety in the months following legalisation.

The study does not take into account the longer-term implications of legalisation despite other studies producing mixed results.

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A study from earlier this year reported that drivers who use cannabis may not feel as impaired as someone else who used the same amount but a different strain.

Read more: Cannabis shortage may have caused a rise in synthetic cannabinoids being consumed

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Industry

Cannabis and IVF: Study reveals consumption may not be associated with compromised effects

The Canadian and Israeli study examined results from over 722 patients who consumed or did not consume cannabis

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IVF: A person holding a blue and white pregnancy test looks down a positive result of two lines across a screen.

A study from researchers in Canada and Israel have revealed that a history of cannabis use is not associated with compromised effects on IVF.

The study, published in the Journal of Cannabis Use, on the effects of a person’s history of cannabis use found it is not associated with compromised effects on in vitro fertilisation (IVF).

The team of researchers from Canada and Israel studied IVF treatment outcomes of male and female, non-donor patients who were cannabis consumers or not. They focused on the ongoing pregnancy rate as well as oocyte yield, fertilization rate, peak serum estradiol, sperm, and embryo quality.

There were 722 participants involved in the research of which, 68 percent were cannabis users who were mostly defined as light consumers. The study revealed a similar implantation rate at 40.74 percent compared to 41.13 percent. It also highlighted similar rates of ongoing pregnancy at 35.2 percent to 29.1 percent between users and non-users. There were no significant differences between consumers and non-consumers in any of the other areas of focus.

IVF and cannabis use

They stated: “Our study did not show any detrimental impact of current cannabis use on any of the measured IVF outcomes. … All the reproductive outcomes of cannabis users and non-users in our study were comparable. These parameters included measures of ovarian response, sperm quality, the efficiency of fertilisation, early embryonic development, and implantation.”

“In fact, the ongoing pregnancy rate per cycle start trended higher for the group of cannabis users (35.2 percent vs. 29.1 percent). This could partially relate to the female participants in the user group being younger than the non-user counterparts.”

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The concluded: “They concluded, “The results of this study are in line with the newer studies suggesting that the use of cannabis is not associated with a compromised outcome for couples undergoing IVF.”

Read more: Could cannabis help with alopecia?

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Industry

Spain approves first cannabis based medicine

The approval for Epidyolex was based on the results of four randomised controlled Phase III trials

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Spain cannabis: A Spanish flag in the air with an old building behind it

Spain has approved the first cannabis based medicine, Epidyolex for patients with severe conditions such as epilepsy.

Epidyolex, an oral cannabis-based medicine, has been approved in Spain by the Ministry of Health after a large two-year trial. The approval for Epidyolex was based on the results of four randomised controlled Phase III trials. The clinical development of the therapy was spread over 10 different hospitals.

The trial involved over 700 participants with severe forms of epilepsy.

Until recently, there was no distinction between recreational and medicinal cannabis use in Spain which made it difficult to obtain products with higher quantities of 0.02 percent THC.

The medicine will only be available in hospital pharmacies for the treatment of seizures caused by Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS).

Spain and medical cannabis

Speaking at a press conference, neurologist Vicente Villanueva, head of the Refractory Epilepsy Unit of the Hospital Universtiari i Politècnic La Fe de València said the trials have found a 40 percent reduction in seizures.  “As clinicians and researchers, we are satisfied to have these new options”, 

Antonio Gil-Nagel Rein, a neurologist and director of the Epilepsy Program of the Hospital Ruber Internacional de Madrid reported: “The potential improvement of the quality of life in an area where therapeutic options are very small is good news. Access to a new drug with a novel and clinically proven mechanism of action is a reason for hope for patients and satisfaction for specialists.”

Epidyolex received approval from the European Commission in September 2019. This made it the first cannabis-based prescription medicine to receive authorisation.

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Read more: Can cannabis reduce the side effects of anti-seizure medication?

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