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How cannabis could be used to transform lives of children with autism

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Cannformatics will explore cannabis-responsive biomarkers in children with autism

The first study of its kind will explore cannabis-responsive biomarkers in children with autism spectrum disorder (ASD).

A pilot study in the US aims to be the first step in helping parents and healthcare professionals find the most effective way to use cannabis to improve the health and quality of life of children.

The observational study, led by Cannformatics – a US biotech startup – is being conducted in collaboration with Dr. Bonni Goldstein, a Los Angeles-based paediatrician who specialises in cannabis medicine.

Researchers will explore how to personalise medical cannabis treatments for individual children, through the identification and application of cannabis-responsive biomarkers found in saliva.

Its aim is to create a trusted resource for parents and health care professionals by providing data and insights to build an effective cannabis regimen for children with ASD.

Saliva samples from children with ASD will be collected pre- and post-consumption of a regularly prescribed dose of medical cannabis, as well as from age-matched neurotypical children.

Cannformatics’ platform will identify biomarkers that significantly changed following the consumption of medical cannabis, while samples from neurotypical children are collected and analysed to determine the baseline for healthy physiological range.

Participants will receive a report showing their individual changes in biomarkers related to ASD symptoms before and after medical cannabis consumption and the study’s overall findings will be published in a scientific journal.

To qualify for participation in the study, all children with ASD are required to be current patients of Dr. Goldstein.

Dr Goldstein, who is also medical Director for Canna – a California-based medical practice devoted to educating patients about the use of cannabis for serious and chronic medical conditions, said: “Identifying cannabis-responsive biomarkers furthers scientific understanding of the role cannabis plays in regulating the endocannabinoid system in children with autism.

“Today I have patients who are responding well to medical cannabis treatment with an improvement in quality of life and minimal side effects. I am optimistic that the data from this study will lead to more positive outcomes for children with autism.

Cannformatics aims to deliver predictable and repeatable science-based medical cannabis recommendations to improve health and quality of life.

Its early successes include identifying two cannabis-responsive biomarkers related to General Anxiety Disorder.

Ken Epstein, Chief Commercial Officer and co-founder of Cannformatics, commented: “This study is the first step toward providing families and health care providers treating autism with recommendations that will provide predictable and repeatable outcomes while improving overall impact.”

The study will also bring together three industry leaders in using cannabis to treat ASD, including Ray Mirzabegian founder of Canniatric and Rhonda Moeller, and Jenni Mai of Whole Plant Access for Autism.

Epstein added: “We are excited to have three medical cannabis trailblazers, who work tirelessly to help their children along with thousands of other families to effectively use medical cannabis. The three of them along with Dr. Goldstein are truly pioneers in using medical cannabis to treat ASD.”

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Journal Club: The CANPAIN trial in focus

This edition of the Journal Club focuses on the recently announced CANPAIN trial.

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The latest issue of the Journal Club, by Grow Pharma, focuses on the recently announced CANPAIN trial.

Introduction

On the 1st of November 2018, the Home Office announced that cannabis-based medicinal products (CBMPs) were to be moved from Schedule 1 to Schedule 2 status in the misuse of drugs regulations, reflecting the view that these agents possess medical utility.

One of the conditions where the scientific literature contains evidence for the utility of medical cannabis is chronic non-cancer pain. Chronic non-cancer pain is also an often-cited reason for patients taking cannabis for medical purposes. Collecting further data on the effectiveness and tolerability of medical cannabis is key in order to potentially pave the way for its approval as an NHS treatment in the future.

Feasibility study

Prior to commencing the CANPAIN trial, a feasibility study will be conducted, with a minimum of 100 patients recruited and followed across a 3-month period. This has been granted REC approval and will aid in establishing likely rates of patient recruitment, duration of participant enrolment in the study, the demographic and geographic spread of patients, patient acceptability of data collection and identify any issues with technological and drug delivery logistics.

The CANPAIN clinical trial

If the feasibility study is successful and no changes are required then the CANPAIN study will be a pragmatic non-randomised, non-blinded real-world trial of the safety, tolerability and effectiveness of a CBMP for the treatment of chronic non-cancer pain compared against matched controls receiving standard of care pain management.

The study could run for 3 years but there will be an interim analysis after 12 months with a planned sample size of at least 5000 participants per group, with each patient completing a minimum of 12-months treatment. The CBMP used will be an 8:8 (8% THC, 8% CBD) balanced flower inhaled by steam using a handheld device with flow counting and Bluetooth connectivity.

The CANPAIN study will consist of an initiation visit (or call) to allow screening and baseline data to be collected and then a follow up visit (or call) every three months thereafter, until the end of the trial.

The primary end-point will be the difference in pain intensity scores among patients in the CBMP group compared to matched controls.

Secondary end-points will include quality of life, sleep, general well-being, and changes in concomitant medication intake. Safety and tolerability of the treatment regimen will also be monitored.

Grow Pharma and IPS pharma are to be the distribution partners for the CANPAIN trial launched by LVL Health alongside partners Aurora Cannabis Inc, Celadon Pharmaceuticals and RYAH group.

Pain consultants who would like to become involved in this clinical trial can contact LVL Health at [email protected]

To sign up to the Journal Club mailing list, click here

 

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What you should know about cannabis and drug interactions

Juicy Fields explores the important considerations of combining cannabis medication and products with drug treatments.

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Juicy Fields: What you should know about cannabis and drug interactions

You have probably read or heard something along the lines ‘consult your physician before taking cannabis if you are on any prescription pills.’ That statement consists of wise words that you should adhere to at all times.

Prescription pills can interact with cannabis, foods, beverages, supplements, and even with each other, leading to mild or severe side effects. Consequently, without sounding redundant, always consult your doctor to avoid such incidents.

What is a drug-drug interaction?

A drug or medication interaction occurs when a person takes a combination of drugs (2 or more) that are incompatible with each other. In such cases, one of the drugs interferes with the other(s) by countering or accelerating their effects. This may lead to drug inefficiency, severe side effects, and sometimes the loss of life.

How does cannabis interact with other drugs?

P450 enzymes metabolize all drugs before they are available in the consumer’s system. The Cytochromes P450 are a group of enzymes responsible for metabolizing many compounds. These enzymes are primarily located in the liver but can also be found in cells throughout the body in small quantities.

There are more than 50 enzymes under the P450 class, but only six are responsible for metabolizing 90% of prescription drugs. These enzymes include CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4. Cannabinoids, THC and CBD, in particular, inhibit or induce the function of these Cytochrome P450 (CYP450) enzymes.

This interferes with enzymatic function, which affects the concentration of certain drugs. Cannabinoids play three prominent roles in drug interactions.

  1. Victims: cannabinoid levels are affected by the presence of another drug.
  2. Perpetrators: the cannabinoids affect the levels of other drugs
  3. Overlapping other drug’s effects: cannabis and other drugs have similar effects on a consumer.

Cannabinoids as drug interaction victims

Ketoconazole, a potent antifungal agent, is a CYP3A4 inhibitor. This enzyme metabolises THC and CBD. Elevated levels of these cannabinoids lead to an increase in the psychoactive effects of THC and adverse side effects of CBD, such as drowsiness and elevated levels of liver enzymes like transaminase. The same results may be experienced with CYP3A4 inhibitors like Verapamil and Macrolides.

CYP2C9 is a P450 enzyme that metabolizes THC and not CBD. Cotrimoxazole, amiodarone, and fluoxetine are classes of drugs that, when consumed, are likely to inhibit the metabolism of THC, leading to increased psychoactive effects. Below is a breakdown of the different classifications of prescription drugs and how cannabis interacts with each of them.

Cannabis interactions with different classes of drugs

Blood thinners

Blood thinners or anticoagulants like warfarin work by preventing blood clots in the body. Combining this class of drugs and cannabis is not advised. THC and CBD can increase warfarin levels in the body by inhibiting the CYP2C9 enzyme. A high warfarin content in the body leads to excessive bleeding that can be fatal.

Benzodiazepines 

Cannabis can interact with benzodiazepines, including Clobazam. The drug is used to treat seizures in Lennox Gastaut syndrome patients. CBD increases the levels of Clobazam by three times through the inhibition of the CYP2C19 enzyme.

Bronchodilators

Bronchodilators are used in opening up airways of patients with lung-related conditions, such as asthma and chronic bronchitis. The drugs become less effective when taken in tandem with cannabis (smoking). This is because cannabis speeds up the metabolism of bronchodilators by 40%.

Psychiatric drugs

Mental health and pain are the leading causes of the sudden rise in medical cannabis consumption. The prevalence of these two conditions is alarming as they are among the top contributors to the global burden of health.

Medical cannabis interacts with psychiatric medications, specifically tricyclic antidepressants like dothiepin and imipramine. The combination may lead to increased heart rate and elevated blood pressure. It may lead to confusion, hallucination, and aggressiveness in severe cases.

Immunosuppressants

Studies suggest that CBD is a potential therapeutic option for kidney transplant patients. The cannabinoid is a natural immunosuppressant and immunomodulator. There are limited documented interactions between medical cannabis and immunosuppressants; however, consult a physician before self-medicating cannabis while taking this classification of drugs.

OTC painkillers

The majority of Over-the-counter pain medications have minimal interaction with cannabis. Drugs containing acetaminophen/paracetamol pose a slight risk of causing liver damage when used with cannabis. Cannabis is a potent analgesic compound that can be utilized to replace OTC drugs. It offers a better, natural alternative with minimal side effects.

Opioids

Medical cannabis has numerous therapeutic and medicinal applications that can benefit millions of patients. One significant contribution that the plant can offer is helping in the fight against the abuse of opioids. Replacing opiates with cannabis reduces the number of fatalities attached to the overdose of opiates.

CBD, in particular, inhibits the function of the CYP2B6, CYP3A4, and other cytochrome P450 enzymes to increase the levels of morphine, oxycodone, and methadone in the body.

While this may be beneficial when opiates are taken in low doses, high doses may lead to excess opiates in the system, leading to an overdose. Additionally, both opioids and cannabis have depressant effects and may significantly compromise the central nervous system when combined.

Antibiotics

There are no recorded interactions between cannabis and antibiotics. Studies available indicate that combining the two may enhance the effectiveness of the antibiotics. Before combining the two, seek advice from a physician.

Take away

Cannabis can interact with different drugs, from opioids to sedatives. Cannabinoids can be the victims of the interactions, whereby their levels of availability in the system are affected by other drugs, such as Ketoconazole.

As perpetrators, cannabinoids inhibit or induce the functioning of P450 enzymes, resulting in the acceleration or delay of the metabolism of drugs. In other instances, cannabis has similar effects as prescription drugs, so the effects overlap.

Medical cannabis is legal in most parts of the world. The plant is easily accessible and is marketed as a potential therapeutic agent for a myriad of conditions. Yes, studies have proven that it does help with pain, mental health issues, mood regulations, inflammation, appetite, and many more diseases. What is usually left out is that cannabis can and does interact with prescription pills.

Before self-medicating with cannabis, always consult a qualified physician, preferably one with medical cannabis expertise. The doctors are best placed to advise on whether you should include cannabis into your treatment regime or not.

Leading crowdgrowing platforms like JuicyFields’, are making medical cannabis accessible for more and more people. You too can join the platform and start making profits with every harvest.

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CBD dominant cannabis does not influence driving skills – study

Participants showed no signs of impairment when it came to driving but they did test positive for trace levels of THC

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A study suggests that CBD-dominant cannabis does not influence the skills associated with driving such as reaction time, concentration, time perception or balance.

The Swiss study examined CBD and THC dominant cannabis flowers to see if they impacted on neurocognitive or psychomotor skills.

Some of the participants were given a CBD dominant strain that had a 16.6:0.9 per cent ratio, and others were given a placebo.

After inhaling the cannabis, participants were asked to undergo the Vienna Test System TRAFFIC. This measures reaction time, behaviour in stressful situations, concentration and performance. They also took further tests to determine their fitness to drive, three separate balance tests and coordination along with vital signs such as blood pressure and pulse.

Driving and cannabis

The participants showed no signs of impairment when it came to driving but they did test positive for trace levels of THC in their blood. The blood tests were taken 45 minutes after consuming the CBD dominant cannabis.

The authors noted that the slight change in THC levels within the system would potentially place patients in violation of traffic safety laws.

The researchers noted: “This finding suggests that higher CBD concentrations cause a negative allosteric effect in the endocannabinoid system, preventing the formation of such symptoms. Nevertheless, it is recommended that consumers refrain from driving for several hours after smoking CBD-rich marijuana, as legal THC concentration limits may be exceeded.”

Driving and THC tests

When it comes to THC and roadside testing, new research revealed that THC levels in blood and saliva are poor measures of impairment.

Researchers analysed a range of studies on the relationship between driving performance and Tetrahydrocannabinol (THC) concentrations in blood and saliva.

The researchers took data from 28 different publications that involved ether ingested or inhaled cannabis. They characterised the relationships between blood and saliva THC concentrations, driving performance and skills such as reaction time or concentration.

When it came to infrequent cannabis users, there were some significant correlations between blood and oral levels of THC and impairments were observed. However, It was noted that these relationships were ‘weak.’

There was no significant relationship noted for the more regular consumers.

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