The latest issue of the Journal Club, by Grow Pharma, focuses on the recently announced CANPAIN trial.
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.
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]
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Mental health, addiction and medical cannabis – an expert’s insight
We sit down with the recently-appointed medical director of The Medical Cannabis Clinics, Dr Luisa Searle.
The recently-appointed medical director of The Medical Cannabis Clinics, Dr Luisa Searle, shares how her background in psychiatry and addiction is feeding into her new role.
Dr Luisa Searle has been treating patients with addiction disorders for the last six years, seeing patients struggling with substance misuse and establishing outreach services for young people and the homeless across London.
Now, she is helping people legally access cannabis, a substance that has historically been demonised as a ‘gateway drug’.
Feeling burnt out and craving a fresh new challenge, Dr Searle was looking for a change in her career when she crossed paths with The Medical Cannabis Clinics, joining the team as medical director in April this year.
“It frustrates me, this division that there seems to be in mental health, whereby if you’ve got a substance misuse issue, you’re not worthy of mental health treatment,” Dr Searle told Cannabis Health.
“But actually, your mental health is often being self-medicated by substances and whether you agree with that or not, that’s how some people cope.”
Prior to joining TMCC, Dr Searle was unaware that medical cannabis was beginning to be prescribed more widely.
She was coming into the industry with a fresh perspective, and despite her background in addiction medicine, she said she had very little prejudice against cannabis.
“It didn’t make sense to me to not explore it,” Dr Searle said.
Dr Luisa Searle, medical director at The Medical Cannabis Clinics
A balanced approach
“I’m not here to say it’s a wonder drug. I’m not here to say it doesn’t have its risks or side effects. It’s by no means suitable for everybody, but this idea that it’s a substance of abuse and not even [worth] researching as a potential medicine I think is, unfortunately, based in historical racism and hysteria, which has no place in science as far as I’m concerned.”
But while she was intrigued by this new and emerging field of medicine, due to her past experience, she was determined to take a “balanced approach” to prescribing.
For Dr Searle, it is imperative that cannabis is seen for what it is. While it has immense potential for managing hard-to-treat conditions and a possible alternative to physically addictive opioids, it is still a substance that can cause dependence.
“Any substance, legal or illegal, with some psychoactive effect has the potential for abuse, but that’s where I come in as the doctor,” Dr Searle said.
“If I felt that you needed diazepam, that prescription is entirely under my control. It is down to me to work with patients to try to prevent [dependency] from happening and to advise and educate them, so that they can make informed decisions about their care.”
Dr Searle is only three months into her role at TMCC but she is already seeing the positive impact that medical cannabis is having on patients.
People with difficult-to-treat conditions like insomnia and anxiety are seeing improvements in their lives after trying numerous conventional treatments that failed to help.
Meanwhile, patients who have previously relied on pharmaceuticals like antidepressants and SSRIs – which can come with severe side effects – were able to “feel themselves” again after reducing their dose of traditional medication in favour of medical cannabis.
“What’s really been nice is seeing success with people who have tried lots of different conventional treatments and haven’t really gotten anywhere,” Dr Searle said.
“I was talking to a gentleman who had a traumatic brain injury and was getting migraines on a regular basis. He had really struggled with his work and his life. With a small amount of medicinal cannabis flower, he feels much more himself.
“That’s the really nice thing [about] working in this clinic; just seeing that turnaround in people who’ve been quite stuck.”
Having worked for the NHS for 15 years, Dr Searle is a firm believer in everyone having access to the healthcare they need.
Right now, this does not apply to the medical cannabis space. Very few people have been able to access an NHS prescription while private prescriptions can cost hundreds per month.
“It is a little bit challenging for me that I have to be in a private clinic in order to provide medical cannabis treatment,” Dr Searle said.
“While TMCC has extremely reasonable prices in comparison to other types of private health care, it is still a cost and if you’re on a low income it might as well be a million pounds.”
Dr Searle wants to see medical cannabis being more widely prescribed, but it has to be “sensible” with regulations around who can prescribe and how.
She continued: “Why shouldn’t it be available on the NHS in the right circumstances? What I don’t want to see is what can potentially happen with opioids – with people becoming dependent on them.
“It’s not a medication for all. There are concerns, particularly among younger people. We’re still not 100 per cent clear as to the risks around potentially life-changing mental health issues and specifically psychosis.”
Importance of eduction
Dr Searle has not encountered huge numbers of cases where recreational users have later developed psychosis, but she has seen enough for it to be a concern.
“It’s not something that I could just dismiss,” she said.
“When we have young people coming to us, it’s all about education. It’s just like any medication, if you start on antidepressants, you don’t start with a high dose, you start on a low dose and build it up. You check the tolerance and you review the patient regularly to see if there have been any improvements or side effects.”
Dr Searle also points out that studies into psychosis and cannabis use have examined street cannabis rather than medical-grade products prescribed by clinics like TMCC.
“Street cannabis potentially has incredibly high levels of THC and very low levels of CBD,” she said
The benefits for some patients speak for themselves, but Dr Searle stresses the fact that a medical cannabis prescription is not right for everyone.
“Whilst I think [medical cannabis] is great and we get lots of positive feedback, we do have some adverse reactions to it where it’s not suitable,” she said.
“People shouldn’t be lulled into a false sense of security that just because your doctor prescribed it and it’s legal for medicinal use it’s not without its risks.”
Dr Searle sees a lot of potential in cannabis as an alternative drug for chronic mental health disorders and pain, even as a possible method for weaning patients off opioids. But she warns that people who are prone to addiction may end up transferring their dependency from one substance to another.
“If you break your leg, opioids are fantastic for that, but what they’re not so good for is chronic pain,” she said.
“The withdrawal process from them can be horrendous and there could be a place for cannabis to alleviate some of those withdrawal symptoms.”
But, she added: “I think I would be much more cautious about that, simply because until you’ve dealt with and understood your addiction and those behaviours and those are resolved and you’ve engaged with other ways to cope with your emotional stresses, you may just be switching one addiction for another.”
Medical cannabis and pregnancy – what you need to know
Canadian cannabis patients use less opioids and alcohol – study
Just under half of patients say they have reduced their use of other controlled substances.
Just under half of Canadian medical cannabis patients say the treatment has enabled them to reduce their use of other controlled substances.
According to new data, nearly one in two Canadian patients authorised to use medical cannabis say they have been able to reduce – or cease entirely – their consumption of other controlled substances, particularly opioids and alcohol.
A team of researchers from Canada and the United States surveyed almost 3,000 Canadian patients enrolled in the nation’s federal medical marijuana programme, which began over two decades ago.
Medical cannabis has been legal in Canada since 2001, the country legalised the possession and retail sale of adult-use cannabis in 2018.
In the research, which was published in the Journal of Cannabis Research, investigators reported that 47 per cent of respondents acknowledged substituting cannabis for other controlled substances.
Of those who said that they used cannabis in place of prescription medications, half acknowledged doing so for opioids – a finding that is consistent with other studies.
Many respondents also reported using cannabis to reduce their alcohol intake.
However, the study highlighted the need for more open communication between patients and their doctors.
Around one-third of respondents did not inform their primary care providers (PCP) that they were engaging in drug substitution.
Authors concluded: “This study examined patient-provider communication patterns concerning cannabis use and substitution in Canada.
“Results suggest that patients often substitute cannabis for other medications without PCP guidance. The lack of integration between mainstream healthcare and medical cannabis could likely be improved through increased physician education and clinical experience.
“Future studies should investigate strategies for effectively involving PCPs in patient care around medical cannabis with specific focus on substitution and harm reduction practices.”
Commenting on the findings, NORML’s deputy director Paul Armentano, said: “Cannabis has established efficacy in the treatment of multiple conditions, including chronic pain, and it possesses a safety profile that is either comparable or superior to other controlled substances.
“It is no wonder that those with legal access to it are substituting cannabis in lieu of other, potentially less effective and more harmful substances. As legal access continues to expand, one would expect the cannabis substitution effect to grow even more pronounced in the future.”
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