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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.*

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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: 

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

* 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

[email protected]  /  www.euro-can.eu

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How THC and CBD work together in the brain – new study

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How THC and CBD work together in the brain – new study

New findings on how CBD and THC – the psychoactive compound in cannabis – affect the brain when administered together, could help to develop new cannabinoid therapeutics, scientists say.

A study has investigated the impact on the brain of CBD and THC, both as separate entities and when co-administered.

Researchers at University College London (UCL) analysed data from previous studies, including one which used functional Magnetic Resonance Imaging (fMRI) technology to measure brain activity in participants taking CBD and THC.

For the first time, they explored the response of the striatum region of the brain – a major part of the motor and reward systems. This is a critical component of numerous aspects of cognition, including motor and action planning, decision-making and motivation.

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One study compared inhaled cannabis containing 8 mg THC, 8 mg THC + 10 mg CBD and a placebo. It showed strong disruptive effects of both THC and THC + CBD on connectivity in the associative and sensorimotor networks.

However it also identified a “specific effect of THC” in the limbic striatum network which was not present in the THC + CBD condition.

In a second study, testing oral 600 mg CBD versus placebo, CBD increased connectivity in the associative network, but produced only relatively minor disruptions in the limbic and sensorimotor networks.

The study concludes that THC “strongly disrupts striato-cortical networks” but that this effect is mitigated by the co-administration of CBD.

It states: “Oral CBD administered has a more complex effect profile of relative increases and decreases in connectivity.

“The insula [part of the brain implemented in diverse functions including emotions and self-awareness] emerges as a key region affected by cannabinoid-induced changes in functional connectivity, with potential implications for understanding cannabis-related disorders, and the development of cannabinoid therapeutics.”

This is the first report in human subjects of data from THC, THC + CBD and CBD use achieved “using a unified set of analysis methods, and with all comparisons performed in a placebo-controlled, double-blind design”.

Read the full report here.

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Five new cannabis studies to have on your radar

The latest scientific papers exploring cannabis and its impact on health and society.

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Five new cannabis studies to have on your radar

Get up to date with the latest cannabis-related research from across the globe.

Over the past few weeks, we’ve seen papers published around inaccurate labelling, the effects of cannabis on Covid-19, the impact of legalisation in Uruguay and how cannabis users might require more sedation during medical procedures.

Read on for five significant studies to dive into.

Lower Covid-19 severity among cannabis users

A recent study has discovered an association between lower Covid-19 severity and cannabis use among hospitalised patients.

The researchers aimed to assess whether current cannabis users hospitalised for Covid-19 had different outcomes compared to non-users through a retrospective analysis of 1,831 patients admitted to UCLA Medical Centre in California.

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Analysis of the data found that cannabis users had significantly better outcomes compared to non-users, shorter hospitalisation, lower ICU admission rates and less need for mechanical ventilation.

Interestingly, the researchers also found that active users had lower levels of inflammatory markers upon admission than non-users.

The authors of the study concluded: “This retrospective cohort study suggests that active marijuana users hospitalised with COVID-19 had better clinical outcomes compared with non-users. However, our results need to be interpreted with caution given the limitations of a retrospective analysis.

“Prospective and observational studies will better help elucidate the effects of marijuana use in COVID-19 patients.”

Cannabis users require more sedation for endoscopy

According to new research, patients who use cannabis required higher levels of sedation during gastric endoscopies than non-users.

As cannabis is legalised in more places and usage continues to rise, researchers in Canada said clinicians should be aware of patients’ cannabis consumption and prepare themselves for increased sedation and the risks that come with it.

The authors of the study conducted a prospective cohort study of 419 adult outpatients undergoing endoscopic procedures at three Canadian centres. Procedures were conducted under conscious sedation, which leaves the patient relaxed and comfortable but partially conscious during the procedure.

Cannabis use was associated with increased odds of requiring higher total sedation during gastroscopy, an endoscopic procedure that begins with the insertion of a tube and camera through the throat.

Legalisation not associated with increased cannabis use among young people

A recent study from researchers in Uruguay found that the use of cannabis following legalisation decreased among teenagers.

Uruguay was the first country in the world to legalise and regulate recreational cannabis. Since legalising the drug in 2016, the country is now regarded as a pioneer, paving the way for other countries like Canada, Mexico and Malta.

Using data from cross-sectional surveys of secondary students in Uruguay and Chile, the study evaluated changes in the prevalence of past-year, past-month and any risky and frequent cannabis use following the enactment and implementation of cannabis legalisation

“The legalisation of recreational cannabis in Uruguay was not associated with overall increases in either past-year/past-month cannabis use or with multi-year changes in any risky and frequent cannabis use among young people,” the authors stated in the paper’s abstract.

Current cannabis labelling system “doesn’t tell you much”

Labels like indica, sativa and hybrid—commonly used to distinguish one category of cannabis from another—tell consumers little about what’s in their product and could be confusing or misleading, suggests a new study of nearly 90,000 samples across six states in America.

Published on 19 May in the journal PLOS One, the research constitutes the largest analysis to date of the chemical composition of cannabis products.

It finds that commercial labels “do not consistently align with the observed chemical diversity” of the product. The authors are now calling for a “weed labelling system” akin to the Food and Drug Administration’s “nutrition facts panel” for food.

“Our findings suggest that the prevailing labelling system is not an effective or safe way to provide information about these products,” said co-author Brian Keegan, an assistant professor of Information Science at CU Boulder.

“This is a real challenge for an industry that is trying to professionalise itself.”

Cannabis dependence treatment is effective in tackling common co-morbidities

Earlier this month, Australian researchers released a paper looking into the effectiveness of cannabis dependency treatment on common co-morbidities, including mood, sleep and pain problems.

The researchers found that the treatment helped decrease anxiety, stress and sleep disturbance among the cohort of 128 cannabis-dependent participants.

The analysis used data from a 12-week double-blind placebo-controlled trial testing the effectiveness of the cannabis-based medicine nabiximols against placebo in reducing illicit cannabis use.

The researchers found that there was “no evidence” that nabiximols treatment is a barrier to reducing co-morbid symptoms. In fact, they found that the treatment reduced illicit cannabis use and improved comorbidity symptoms, even when participants were not able to achieve abstinence.

 

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Research finds cannabis consumers may require more sedation

Consumers required higher levels of sedation during endoscopic procedures than non-users

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Research finds cannabis consumers may require more sedation

Experts have highlighted the need for doctors to be more aware of their patients cannabis use, as research suggests consumers may require higher levels of sedation.

As cannabis is legalised in more places and usage continues to rise, researchers in Canada said clinicians should be aware of patients’ cannabis consumption, and prepare themselves for increased sedation and the risks that come with it.

It comes as a new study has associated cannabinoid use with increased odds of requiring higher total sedation during gastric endoscopies – a procedure that begins with the insertion of a tube and camera through the throat – than non-users.

The authors of the study conducted a prospective cohort study of 419 adult outpatients undergoing endoscopic procedures at three Canadian centres.

Procedures were conducted under conscious sedation, which leaves the patient relaxed and comfortable but partially conscious during the procedure.

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Researchers did not examine its impact on propofol sedation, which is more commonly used in the UK and US so more research would be needed to determine the wider impact of cannabis use on sedation.

“Patients didn’t have increased awareness or discomfort during procedures, but they did require more drugs,” said Yasmin Nasser, MD, PhD, lead researcher on the study and assistant professor at Snyder Institute for Chronic Diseases at the University of Calgary.

Each patient completed two questionnaires, one before the procedure about their cannabis use and another afterwards, indicating their awareness and comfort level during the procedure. The questionnaires were analysed along with details about the use of the sedatives midazolam, fentanyl and diphenhydramine during the procedure.

Cannabis use was associated with increased odds of requiring higher total sedation—defined as more than 5 mg of midazolam, or more than 100 mcg of fentanyl, or the need for diphenhydramine.

Interestingly, cannabis use was not associated with higher use of sedation during colonoscopy. Researchers said this could be because gastroscopy generally requires more sedation than colonoscopy due to the irritation caused in the upper part of the gastrointestinal tract.

Cannabinoid use was not independently associated with fentanyl use or adverse events, nor was it associated with intra-procedural awareness or discomfort, the authors found.

This study looked at whether patients were users or non-users of cannabis, but did not examine the timing, quantity or route of cannabis intake prior to the procedure. Researchers say these variables could be the basis for future studies.

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