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CBD and insomnia : CBD company and research centre to launch new trial

The trial will not only test the effects of insomnia on patients but their stress and anxiety levels to with the aim of creating a new product

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Insomnia: A sleep mask, cannabis leaves, capsules and a cup of tea with a cannabis leaf sit on a purple duvet

Could cannabis help with insomnia? CBD and medical cannabis company BOD Australia have partnered with the Woodcock institute to launch new trial.

The insomnia research and agreement between BOD Australia and the Woodcock Institute will involve a phase IIb clinical trial. It is aimed at developing a new CBD product.

The study will investigate the effect of insomnia severity index scores on adults between 18 and 65 years old. The index asks patients to rate their difficulties falling, staying asleep or waking up too early.

The researchers will recruit around 200 participants struggling with insomnia and run for 12 weeks. They hope to compare both a placebo and a CBD product. During the trial, patients will take a placebo and their new CBD medication in 50mg and 100mg doses. The trial will also determine objective sleep indices as well as participant’s stress and anxiety levels.

The finished trial will allow the company to patent the product for sale over the counter. The company hope to make this available in Australia followed by the UK and US.

 

Australian research

The Woodcock Institute is Australia’s leading sleep and respiratory research organisation.

Head of sleep and circadian research at the Woolcock Institute, professor Ron Grunstein commented: ”Given the need for alternative treatments for insomnia, it is critical to investigate the effect of CBD on sleep through a high-quality study.”

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CEO Jo Patterson said: “We look forward to working with the Woolcock Institute and are confident that the results of the completed clinical trial will provide the required data to commercialise an over-the-counter Schedule 3 CBD product for Australian consumers.”

Insomnia studies

The Woodcock Institute is also working on another insomnia trial which has just finished recruiting participants. It aims to examine how cannabinoids can help people with insomnia and sleep disorders.

PhD student Anastasia Suraev is hoping to generate new data to inform further research, policy and clinical practice. In the video, she stated that 30 percent of the Australian population experience insomnia or poor quality sleep. Her research will test a ratio of CBD to THC thought to promote better sleep in oil form.

Her research will test the effects of this on sleep and daytime function in people with insomnia. The medication will consist of a controlled ratio of cannabinoids consumed as oil for slower absorption and longer-lasting effects. Participants will undergo brain imaging scans to discover if cannabinoids can help insomnia and are there any longer last effects the next day.

Read more: Can CBD help me sleep?

Epilepsy

BPNA publishes new guidance on prescribing medical cannabis in epilepsy

The updated guidance has been described as ‘unethical’ by medical cannabis experts.

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The BPNA has been accused of trying to “block private access” to cannabis-based medicines

New guidance published this month by the BPNA on the prescribing of medical cannabis, has been described as ‘unethical’ by experts.

The British Paediatric Neurology Association (BPNA) this month updated its guidance for clinicians on the prescribing of cannabis-based medicines for children and young people with epilepsy.

It’s the first time the framework has been updated since 2018 and comes following the amendments to the NICE guidelines earlier this year, clarifying that clinicians can prescribe medicinal cannabis in appropriate cases.

The BPNA’s view that it must be a paediatric neurologist who prescribes, is not supported by national guidance, with the Medical Cannabis Clinicians Society (MCCS) recently highlighting that it is “legal and acceptable” for a paediatrician with an interest in epilepsy to prescribe, under a shared care arrangement with a trained cannabis physician. 

This, along with its insistence that there is “no evidence” for the safety and efficacy of medical cannabis products and “concerns” about the effect of exposure to THC on the developing brain, is widely blamed for the lack of access to NHS prescriptions for children with epilepsy. 

Blocking private access

But while many would hope any new guidance would make things easier for doctors wishing to prescribe cannabis-based products, the BPNA has been accused of making things worse for patients and even trying to “block private access”, as well as that through the NHS.

The BPNA has now put the onus on the prescribing doctor to ensure families can afford to carry the financial burden of accessing this medicine privately.

“If a paediatric neurologist prescribes an unlicensed CBPM in private practice they should also be certain that the family can sustain the cost of ongoing private prescriptions,” the BPNA states.

We consider it unethical to initiate a treatment in private practice for which funding is not available in the longer term. The NHS is unlikely to meet the cost of future prescriptions of an unlicensed medicine that has no Level 1 evidence of efficacy and safety.

It comes following reports of parents being forced to sell their home and rely on fundraising to pay for these medicines privately, an average cost of £2,000 per month.

The Medical Cannabis Clinicians Society (MCCS) has slammed this move as “totally unacceptable” and accused the BPNA of driving patients to the black market with its “outdated” stance. 

Professor Mike Barnes

Its chair, Professor Mike Barnes, told Cannabis Health: “It is not in any way standard practice for a doctor to enquire whether a family can support funding in the long term. Such an inquiry is unethical and such a situation would of course not arise if a doctor prescribed it on the NHS, as is legal. 

“The stance of the BPNA is driving patients and their families into private practice and in some cases into the black market.”

Hannah Deacon, director of the MCCS and mother to Alfie Dingley, agreed, saying this would leave patients denied access in every avenue. 

“The BPNA now appears to be trying to shut down private access as well as NHS access,” she said.

“This new guidance is placing all the onus onto the private doctor to be responsible for ensuring that families can afford to pay for the prescriptions before they’re issued. There would be no way that any private doctor would do that for any other medication. This guidance causes harm and all it’s going to do is push people to the black market.”

Real world evidence

The BPNA claims that the prescribing of cannabis medicines is “largely untested”, despite the fact that there are now over 10,000 patients prescribed for in the UK including around 200 children with treatment-resistant epilepsy. 

The MCCS also points out that there is a “significant volume of efficacy and safety data” in the form of real world evidence. 

Members of the BPNA have been trained in the prescribing of pharmaceutical products which have RCT data behind them,” Deacon said.

“What we would urge them to understand is that this is a botanical medicine with many hundreds of compounds which cannot go through the randomised control trial process effectively, and real world evidence very much has its place here to prove safety.”

The impact of not prescribing

Prof Barnes added that the new guidance has failed to recognise the “downsides of not prescribing” which include a poorer quality of life, brain damage and even death.

“There is no recognition of the fact that these children have uncontrolled, drug resistant epilepsy by definition. They have a poor quality of life, often difficulties in school and in play and at home and the whole family suffers from the consequences,” he said.

“Recurrent seizures are damaging to the developing brain and such severe seizures are associated with a risk of status epilepticus and death. Every avenue must be explored in an attempt to alleviate the seizures. Cannabis is not a cure-all and is not the right medication for every child (or adult). However, it has been shown to have efficacy in many cases and is generally remarkably safe.”

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Pain

71% of CBD users self-determine dosage without professional help

A large percentage of of those who use CBD for pain determined the dosage through trial and error

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A new survey has revealed that 31 per cent of respondents use CBD to treat pain – but found that 71 per cent of those do not check the dosage with professionals first.

The dosage survey conducted by industry watchdog, Leaf Report, reported that 22 per cent of 1360 respondents did not check their dose before taking CBD.

Almost three-quarters of those surveyed said they do not seek professional advice while 29 per cent did. A further 44 per cent decided the dosage themselves based on trial and error.

Dosage: A banner advert for Medical Cannabis Clinic

CBD-infused gummies, edibles, and beverages were the most popular method of taking CBD with a further 26 per cent preferring oils or tinctures. Vapes were the least favourite method of consumption at 10 per cent.

The survey asked a series of eleven questions about dosage and use. Among the findings, it revealed that 48 per cent of participants took the same dosage every time while 26 per cent do not check the concentration of their CBD products.

Just over half the respondents used CBD for pain with 31 per cent using it every day.

Lital Shafir, head of product at Leafreport said: “After our team reviewed the findings from the dosage survey, we realized that most users are not seeking out the opinions of professionals when trying CBD, which can lead them to negative experiences.”

“Our mission at Leafreport has always been to educate consumers on the many aspects of the CBD industry, and we want to offer educational tools like extensive reports for those who want to get away from ‘trial and error’ tactics when taking CBD.”

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Correct dosage and misinformation

This survey findings are similar to another conducted on cancer patients earlier this year.

The earlier survey of 100 cancer patients at an oncology care clinic revealed they are interested in trying CBD to allievate symptoms but lack information about how to take it. Both set of findings highlight the need for more education around CBD. The main symptoms listed were uncontrollable pain, depression and anxiety.

The survey of 100 patients at an oncology care clinic showed participants were interested in CBD as a way to alleviate symptoms. They listed their main symptoms as uncontrolled pain, depression and anxiety.

When asked about their understanding of CBD, 45 percent said they were unsure if there were any risks. A further 17 percent believe there was no or low risks but 25 percent “reported uncertainty of the alleged benefits of using CBD.”

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Events

Menopause: Could CBD offer relief from symptoms?

Increasingly women are finding cannabinoids helpful in managing some of the menopause symptoms.

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Menopause: A small bottle of oil on a surface surrounded by cannabis leaves

Ahead of a new webinar on cannabis and menopause, we share the stories of women who have found cannabinoids helpful in managing symptoms.

Rachel’s story

At first, Rachel had struggled to conceive naturally and was delighted when her first round of IVF was successful and went on to give birth to her son. A year later, after going to the hospital for a routine check-up, she was surprised to have received a call asking her to come for an emergency scan. She then found out she had a 12cm tumour on one of her ovaries. She then had surgery to remove it and was left with half an ovary.

“After my initial surgery, I was advised to get a hysterectomy to fully deal with the tumour. At first, I had resisted, but eventually, I felt I needed to go through with it. Having the hysterectomy meant that I went into premature menopause. I had really struggled to come to terms with this as I wanted to have a second child. But I knew I had to carry on and help other women who have had the same experiences as me.

Rachel had already been using CBD to help her deal with poor sleep and anxiety. She found that CBD was really helpful in dealing with her menopausal symptoms such as low mood and hot flushes.

“The CBD was transformational, I found that I could sleep through the night and my anxiety levels had gone way down. It has completely changed my life helped me to deal with my symptoms and the stress and anxiety associated with menopause.”

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Cannabis medicines and menopause

Cannabis Health, Integro Medical Clinics and Cannabis Patients Advocacy and Support Services (CPASS), PLEA and Primary Care Cannabis Network present a webinar that will focus on the challenging experiences of women who have found cannabis medicines helpful in managing the symptoms of menopause.

Menopause: An event image advertising a panel discussion around women's cannabis and menopause

Menopause and perimenopause symptoms are chronically poorly managed in the modern healthcare system.

Many women are simply told to ‘manage their stress better, lose some weight’ or ‘do more exercise’ when seeking medical treatment for symptoms that can have a huge impact on their day to day lives, including anxiety, depression, insomnia, low libido, headaches and hot flushes.

This is due to several factors, both cultural and medical. While women often feel ashamed to speak openly about their experiences due to stigma, many doctors lack the training and time to treat symptoms effectively.

Increasingly women are finding cannabinoids helpful in managing some of the menopause symptoms.

Since the legalisation of cannabis-based medicines two years ago, female patients have been able to discover that the rebalancing of their endocannabinoid system can be incredibly helpful in the management of conditions ranging from endometriosis, bladder and nerve pain, gynaecological pain and PMS to mental health conditions such as anxiety, insomnia and depression.

Aimed at both the general public and caregivers, the event will explore the experiences of women who have lived with perimenopause and menopause symptoms and how they have found cannabis-based medicines helpful.

We will discuss openly and candidly the realities of the transition and the stigma surrounding it in society.

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Expert speakers include:

 

Menopause: Dr Sally Ghazaleh

Dr Sally Ghazaleh – Female Health Consultant at Integro Clinics. She specialises in managing patients with lower back pain, neck pain, neuropathic pain, abdominal pain, cancer pain and complex regional pain syndrome.

 

Menopause: Dr Mayur Bodan

Dr Mayur Bodani – A neuropsychiatrist with over 25 years of experience, he has successfully treated many patients with psychiatric disorders such as depression, bipolar disorder, anxiety, psychosis, dementia and many other conditions.

Patient speakers include:

Lauren

Lauren CB – having been a successful mental health nurse for 30 years, Lauren had to give up her career after being diagnosed with primary progressive MS. She has found cannabis medicines helpful in dealing with her MS symptoms and menopausal symptoms.

Rachel Mason

Rachel Mason – founder of ‘Our Remedy‘, a wellness brand for women. She has found CBD to be very helpful in dealing with her menopausal symptoms.

The webinar is completely free of charge, click here to register 

 

For more information visit www.integroclinics.com

Email: Contact@integroclinics.com

Twitter: @clinicsintegro

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Cannabis Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. All content on this site is intended for educational purposes, please seek professional medical advice if you are concerned about any of the issues raised.

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