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First clinical trial to study cannabis as treatment for migraine

The world’s first randomised controlled trial for cannabis as a migraine treatment is underway in the US.

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Migraines produce symptoms that are often intense and debilitating.

The world’s first randomised controlled trial for cannabis as a treatment for migraine is underway in the US.

Scientists at the University of California, San Diego are conducting the first known randomised, double-blind, placebo-controlled clinical trial looking at cannabis as a potentially effective treatment for acute migraines.

Migraines produce symptoms that are often intense and debilitating.

They cause severe throbbing or pulsating headaches, usually on one side of the head, often accompanied by nausea and sometimes vomiting and/or extreme sensitivity to light and sound.

A migraine attack can last for hours or even days.

Although there are numerous FDA-approved treatments on the market, experts say many patients are turning to cannabis products containing THC and/or CBD, an ingredient of cannabis that is not psychoactive, to treat their migraines.

Researchers are hoping this study will help give clinicians the confidence to prescribe cannabis safely.

Approximately 20 participants are currently enrolled in the clinical trial. One of them is Allison Knigge, who was in elementary school when she started to experience migraines. They continued to get progressively worse as time went on, especially after the birth of her son.

“I would describe my migraines as a piercing pain. It feels like my brain is being squeezed. It causes extreme sensitivity to light and sound and horrible nausea,” said Knigge. 

“There have been times when I have been at a pain level of 6 or higher for approximately 25 days out of the month. They impact my quality of life.”

Knigge says she has tried several medications over the years, but none have been able to fully manage her migraines.

“My migraines are triggered by the weather, stress and lack of sleep. When the pain gets to peak levels, I am in bed all day with the lights out,” said Knigge. 

“When I am experiencing a migraine, I am completely out of commission, and that is a challenge as a mom.”

Nathaniel Schuster, MD, pain management specialist and headache neurologist at UC San Diego Health and investigator at the UC San Diego Center for Medicinal Cannabis Research said: “Many patients who suffer from migraines have experienced them for many years but have never discussed them with their physicians. They are, rather, self-treating with various treatments, such as cannabis.

“Right now, when patients ask us if cannabis works for migraines, we do not have evidence-based data to answer that question.”

Participants who will be randomised to treat four separate migraine attacks with four different treatments; one each with THC, CBD, a combination of the two and a placebo. The products are administered via a vaporiser.

Schuster added: “Vaporised cannabis may be more effective for those patients who have nausea or gastrointestinal issues with their migraines.”

To qualify for the clinical trial, patients must experience migraines every month, must not be a regular cannabis user or use opioids, and must be age 21-65.

“I am proud and grateful to be part of a study that could lead to more tools in the toolbox for those of us who suffer from migraines,” said Knigge. 

“It could mean one more option when all other options have not worked. This is truly significant for patients whose lives are disrupted on a regular basis from migraines.”

Schuster said future studies would include comparing different doses of cannabinoids.

This study is funded by the Migraine Research Foundation, to learn more visit UC San Diego Health Clinical Trials 

 

Advocacy

Fair Trials and Last Prisoner Project seek to launch global cannabis justice project

Fair Trials’ Global CEO Norman L. Reimer to discuss the project at Cannabis Europa Conference in London on June 29.

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A new initiative from Fair Trials and the Last Prisoner Project aims to redress the harm caused by cannabis prohibition and to secure relief for those in prison for cannabis-related convictions.

The criminal justice reform NGO, Fair Trials hopes that the industry will support its work in countries across the globe where cannabis laws are being liberalised. Through collaboration with local partners in appropriate jurisdictions, the Fair Trials project will identify people in need of legal assistance, and recruit, train and match volunteer lawyers to take on their cases.

Fair Trials has enlisted the help of the Last Prisoner Project, a coalition of cannabis industry leaders, executives and artists dedicated to bringing restorative justice to the cannabis sector.

More and more jurisdictions are allowing adults to use and distribute medical and recreational cannabis. But after decades of prohibition, countless people remain behind bars or continue to suffer the collateral consequences of a cannabis conviction.

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“The injustice of cannabis prohibition has resulted in millions of people worldwide serving time in prison or being saddled with a cannabis conviction, which brings with it a lifetime of harmful consequences, ranging from education and employment opportunities to immigration status and parental rights,” said Fair Trials Global CEO, Norman L Reimer.

“Of course, these harmful effects of prohibition not only impact the individuals charged, but also their families and communities. And those effects have been borne disproportionately by minorities, communities of colour, and the socio-economically disadvantaged. Legalising cannabis alone does not equal justice. Together, we must address the ongoing harms of past prohibition and leave no cannabis prisoner behind.”

The project will be modelled on the US Cannabis Justice Initiative, a collaborative effort between the cannabis industry and volunteer lawyers in the United States. When Norman Reimer was the Executive Director of the National Association of Criminal Defense Lawyers (NACDL), he partnered with the Last Prisoner Project to establish the initiative.

“Key to the success of the initiative has been generous donations from legal cannabis companies and consumers nationwide,” said Last Prisoner Project Co-Founder Steve DeAngelo. “Fair Trials, with its global reach as the world’s criminal justice watchdog, is uniquely positioned to build and house the infrastructure that’s going to be needed.”

Tomorrow (29 June), Norman Reimer will address the Cannabis Europa Conference discussing the project. Mr Reimer will be part of a panel entitled ‘Leave No Cannabis Prisoner Behind,’ and will be joined on that panel by Mary Bailey, Managing Director at the Last Prisoner Project; Dr. Laura Garius, Policy Lead at Release; and Denzel Uba, an individual impacted by criminal cannabis prohibition.

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TOWIE star Amy Childs launches CBD range in honour of Jorja Foundation

The product range sees a portion of the proceeds going to the Jorja Foundation.

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Amy Childs at the launch of her new CBD range, Jorja Botanicals

TOWIE star Amy Childs launched her new CBD range this week, with a star-studded event that shone a spotlight on the story of six-year-old Jorja Emerson.

Amy Childs was joined by former Love Islanders, Amy Hart and Cara Delahoyde-Massey, alongside her  co-stars, Frankie Essex, Tom Skinner, Carina Lepore, Saffron Lempriere and Mark Ferris, for a heart-warming event celebrating the launch of her new CBD Infused beauty range, Jorja Botanicals.

The signature collection sees a portion of the proceeds going to the Jorja Foundation, which was set up in honour of six-year-old medical cannabis patient, Jorja Emerson.

The event saw The Only Way Is Essex star Frankie Essex, break down in tears as she heard Jorja’s story. Frankie, who gave birth to twins four weeks ago, wiped her eyes when Robin Emerson, Jorja’s father, showed videos of the life-threatening seizures his daughter was suffering before they discovered medical cannabis

Love Island star, Amy Hart has since taken to Instagram to spread the word about the latest political campaign that sees Childs and Emerson petitioning to make medical cannabis more widely available on the NHS

The Jorja Botanicals range was inspired by Jorja, who was diagnosed with a rare chromosome abnormality called 1q43q44 deletion, which has a side effect of life-threatening seizures. Her illness resulted in her being admitted to intensive care on two separate occasions, where Robin was told that she may not make it.

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TOWIE stars joined Amy Childs for the launch of her new CBD range

To save his daughter’s life, Emerson knew that he had to dig deep and find a treatment that would not only help Jorja but ultimately go on to help others.

At the time it was still illegal to prescribe cannabis in the UK. Emerson joined the campaign to see medical cannabis legalised in the UK in November 2018, and Jorja’s was among the first children to be legally prescribed medicinal cannabis.

In 2021 he went on to create the Jorja Foundation – a charity set up to help other families and children going through the same battles that Robin had to face.

The Jorja Foundation’s core principles are to fund special needs equipment that is not funded through the health system, fund family counselling, private appointments and tests when a second opinion is needed, as well s cannabis-based treatment for children in the UK and to continue to campaign and educate for wider NHS access in the UK for cannabis-based medications.  

Childs commented: “When I saw Robin & Jorja’s story on social media it broke my heart.

As a mum, I couldn’t imagine the pain of being told to take my child home to say goodbye to them. I love that Robin has fought for Jorja & is now helping other families with the Jorja Foundation. 

“I’m so happy that I can help the foundation by being the Creative Director of Jorja Botanicals. We have created some beautiful products for the whole family to enjoy. We will be donating a percentage of the proceeds to the foundation so that we can help as many families as possible. ”

 Emerson added: “ This is the fruition of a lot of hard work over many months and I am extremely proud to launch what is the first family brand in this category. In the coming weeks, we will also be launching a ‘parent’ focused cosmetic range in partnership with our creative director Amy Childs and our premium line of tincture oils.”

 

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South Africa launches first trial of cannabis for chronic pain

The study will test whether cannabis can replace opioids in the management of chronic pain.

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South Africa’s first cannabis trial has launched after initial results “show promise” for the treatment as a replacement for opioids.

The Pharma Ethics Observational Study is led by Biodata, a subsidiary of Labat Africa, and will test whether cannabis can replace opioids in the management of chronic pain.

The study will involve 1,000 participants who have been taking opioids for pain management for at least three months and are prepared to switch to cannabis as an alternative.

Biodata is the brainchild of Dr Shiksha Gallow, a cannabis clinician and the principal investigator in the trial which took over 18 months to get official clearance.

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Dr Gallow said the trial is set to be ground-breaking as South Africa’s first real-world study of medical cannabis. Researchers predict that it will provide much-needed insight into the link between cannabis genetics and patient outcomes.

Dr Gallow told Cannabiz Africa: “We are currently recruiting patients, and data-capturing all the questionnaires and feedback from the patients for the live Study. It has been fairly slow. However, more options have been introduced, as suggested by the patients in the pilot study.

“The pilot results of the study were very promising, as it showed 98 per cent of the patients have some sort of pain relief from the cannabis.

“We were able to wean these patients off their opioid treatment. In the pilot group of patients below the age of 55, it was shown this group preferred to smoke cannabis and patients older than 55 years preferred oil. The patients who smoked the cannabis had relief almost immediately, while the oil took some time to alleviate their pain.”

“Once we reach the sample size required and all of the relevant data has been collated, the results of the study will be published. We have currently renewed this study for another year, due to the initial slow uptake of research participants.”

Patients can apply to be research participants through the Biodata website.

Labat is expanding its footprint over the next few months with the introduction of CannAfrica kiosks in major shopping malls.

The company believes these will be the “ideal locations for physical sign-up points for the study”.

Labat said the kiosks will also serve as Biodata dispensaries and is engaging with a number of vape stores to do the same, although these would have to be subject to South African Health Products Regulatory Authority’s pharma-ethics requirements.

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