Tag: cannabis-based medication

Lesser-known Cannabinoid Relieves Stress in Clinical Trial

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A lesser-known cannabinoid that is gaining in popularity, Cannabigerol (CBG), was shown to effectively reduce anxiety in a clinical trial – without the intoxication typically associated with whole plant cannabis. It may even have some memory enhancing effects, according to a new study in Scientific Reports.

For the study, Carrie Cuttler, an associate professor of psychology at Washington State University, and colleagues conducted the first human clinical trial investigating the acute effects of CBG on anxiety, stress and mood.

The research revealed that 20mg of hemp-derived CBG significantly reduced feelings of anxiety at 20, 45 and 60 minutes after ingestion compared to a placebo. Stress ratings also decreased at the first time point compared to the placebo. The findings align with survey data from a previous study led by Cuttler that indicated 51% of CBG users consume it to decrease anxiety, with 78% asserting its superiority over conventional anxiety medications.

“CBG is becoming increasingly popular, with more producers making bold, unsubstantiated claims about its effects,” Cuttler said. “Our study is one of the first to provide evidence supporting some of these claims, helping to inform both consumers and the scientific community.”

For the study, Cuttler’s team at WSU and colleagues at the University of California, Los Angeles, conducted a double-blind, placebo-controlled, experimental trial with 34 healthy cannabis users. The participants completed two sessions over Zoom during which they provided baseline ratings of their anxiety, stress and mood.

They then ingested either 20mg of hemp-derived CBG or a placebo tincture mailed to them ahead of time. The participants then rerated their mood, stress, anxiety and other variables such as feelings of intoxication and whether they liked how the drug made them feel at three different time points post-ingestion. Additionally, they reported on potential side effects like dry eyes and mouth, increased appetite, heart palpitations and sleepiness.

The sessions were repeated a week later with the participants taking the alternate product prior to completing the same assessments. The design ensured that neither the participants nor the research assistants knew which product was administered.

Surprising outcomes

One of the most surprising outcomes was CBG’s effect on memory. Contrary to expectations based on THC’s known effects on memory, CBG significantly enhanced the ability to recall lists of words. Participants were able to recall more words after taking 20mg of CBG than after taking a placebo.

“We triple-checked to ensure accuracy, and the enhancement was statistically significant,” Cuttler said.

Furthermore, the study found that CBG did not produce cognitive or motor impairments, or other adverse effects commonly associated with THC, the psychoactive ingredient in cannabis. Participants in the experimental group reported low intoxication ratings and minimal changes in symptoms like dry mouth, sleepiness and appetite. Contrary to previous self-report surveys where users touted CBG’s antidepressant effects, the participants in the current study did not report significant mood enhancement after taking CBG.

While the research is promising, Cuttler cautions the results should be interpreted carefully due to the study’s limitations. The use of experienced cannabis users, the modest dose of CBG and the timing of assessments might have influenced the findings. Additionally, the study’s remote nature, conducted via Zoom, and lack of physiological measurements further constrain the conclusions.

“We need to avoid claims that CBG is a miracle drug. It’s new and exciting, but replication and further research are crucial,” Cuttler said. “Ongoing and future studies will help build a comprehensive understanding of CBG’s benefits and safety, potentially offering a new avenue for reducing feelings of anxiety and stress without the intoxicating effects of THC.”

Moving forward, Cuttler and her team are designing a new clinical trial to replicate their findings and include physiological measures such as heart rate, blood pressure and cortisol levels. They also plan to extend the research to non-cannabis users. Additionally, Cuttler is planning a study on CBG’s effects on menopause symptoms in women.

Source: Washington State University

Cannabis is Being Prescribed for Mental Health Disorders Without Evidence

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New research shows Australian healthcare practitioners are often prescribing medicinal cannabis for psychiatric conditions where the evidence for effectiveness is unclear. But researchers who looked into the prescribing data believe that perhaps something has been overlooked, possibly leading to new avenues for treatment. The findings come University of Sydney researchers and are published in Frontiers in Pharmacology.

“These data confirm many Australians have unmet needs around their mental health and that medicinal cannabis is now frequently being trialled as an alternative to conventional therapies,” said study leader Dr Elizabeth Cairns.

“Medicinal cannabis is not typically prescribed as a first-line therapy, so those using it for conditions such as anxiety and depression likely have not had success with other treatments.

“This provides us with new leads for our clinical trials that will hopefully produce high-quality evidence to support or discourage current patterns of use.”

Dr Cairns and colleagues analysed the complete record of medicinal cannabis prescribed through Special Access Scheme B (SAS-B), using data supplied by the Australian Therapeutic Goods Administration (TGA) going back to the drug’s legalisation there in 2016, which allowed a diverse range of CBD and THC products to be legally available for medical use.

Prescriptions through this scheme have been increasing annually since the drug made its way into Australia’s pharmaceutical market in late 2016. From February 2021 the number of prescriptions started to boom, leaping from 100 000 to 300 000 by September the following year.

After treatment for chronic pain, analysis by the Lambert researchers shows anxiety is the second most common condition being treated with prescribed medicinal cannabis in Australia. However, evidence for the effectiveness of medicinal cannabis products in treating anxiety is surprisingly poor.

There is also increasing prescribing for conditions such as depression, ADHD and autism where an “evidence gap” exists around effectiveness.

Psychiatric prescriptions, used to treat mental, emotional, developmental and behavioural disorders, make up 33.8% of total approvals.

“Despite prescribing for a variety of different psychiatric indications, there is limited published high-quality evidence of efficacy to support this prescribing,” Dr Cairns said.

“The key here is not that the evidence shows cannabis products don’t work, more that high-quality studies supporting current prescribing just haven’t been done.”

Medicinal cannabis has been approved for anxiety disorders far more than any other psychiatric condition, making up 22.6% of all SAS-B prescriptions, and the type of medications used to treat anxiety caught the interest of scientists at Lambert.

“The anxiety data are really interesting because more than three quarters of the products prescribed contain THC (tetrahydrocannabinol), but THC is often thought of as anxiety-inducing, with cannabis use sometimes associated with paranoia and social anxiety,” Dr Cairns said.

“It makes you think, is there something about THC that we’ve missed historically?”

Dr Cairns suggested more priority research funding is needed to examine the effectiveness of medicinal cannabis products at improving mental health and quality of life.

The researchers said healthcare professionals often struggle to find reliable information about prescribing the hundreds of medicinal cannabis products available, and whether THC or CBD products are best used for different psychiatric conditions. 

Source: University of Sydney

Cannabis is Moderately Effective for Chronic Pain, Review Finds

Cannabis’s pain reduction effects appear to be less effective than previously though. Photo by Kindel Media

Cannabis product use provides modest, short-term improvements in chronic pain, albeit with some side effects, according to a large review of research on cannabis pain management. The review also revealed a general lack of high quality evidence such as randomised controlled trials (RCTs). The data will be uploaded to a web app made by Oregon Health & Science University to inform clinicians on cannabis medications.

Reporting in Annals of Internal Medicine, researchers found evidence to support a short-term benefit in treating neuropathic pain with two synthetic products with 100% tetrahydrocannabinol (THC): dronabinol (under the trade name Marinol) and nabilone (Cesamet). Another product, a sublingual spray of equal parts THC and cannabidiol (CBD), known as nabiximols, also showed evidence of some clinical benefit for neuropathic pain. All of the products had side effects, such as nausea, sedation and dizziness.

From 3000 studies, the researchers selected RCTs or comparative observational studies of patients with chronic pain that compared cannabis products with a placebo or no treatment (that is, usual care) for at least 4 weeks of treatment or follow-up.

They ended up with a total of 25 with scientifically valid evidence – 18 RCTs and seven observational studies. Cannabinoids were categorised as high, comparable, or low THC-to-CBD ratio. The researchers found:

  • Synthetic products with high THC (> 98%) and little or no CBD: moderate improvement in pain, but greater sedation risk and possible increase in dizziness
  • Extracted products with majority THC (THC:CBD ratio ranging from 3:1 to 47:1): no significant improvement in pain, but greater study withdrawal because of adverse events and dizziness
  • Sublingual sprays with comparable THC and CBD levels: small improvement in pain but a much greater increased risk of dizziness and sedation and a moderate increase in nausea

Besides these findings, there was little evidence to support any other conclusions.

“In general, the limited amount of evidence surprised all of us,” said lead author Marian S. McDonagh, PharmD, emeritus professor at OHSU. “With so much buzz around cannabis-related products, and the easy availability of recreational and medical marijuana in many states, consumers and patients might assume there would be more evidence about the benefits and side effects.

“Unfortunately, there is very little scientifically valid research into most these products. We saw only a small group of observational cohort studies on cannabis products that would be easily available in states that allow it, and these were not designed to answer the important questions on treating chronic pain.”

“For some cannabis products, such as whole-plant products, the data are sparse with imprecise estimates of effect and studies had methodological limitations,” the authors noted.

This situation makes it difficult to guide patients.

“Cannabis products vary quite a bit in terms of their chemical composition, and this could have important effects in terms of benefits and harm to patients,” said co-author Roger Chou, MD. “That makes it tough for patients and clinicians since the evidence for one cannabis-based product may not be the same for another.”

The living review, including a visual abstract summary of the findings, will also be shared on a new web-based tool launched by OHSU and VA Portland Health Care System early this year to help clinicians and researchers evaluate the latest evidence around the health effects of cannabis. Known as Systematically Testing the Evidence on Marijuana, or STEM, the project includes ‘clinician briefs’ to help health care workers translate the clinical implications.

“This new living evidence review is exactly the type of resource clinicians need to clarify for patients the areas of potential promise, the cannabis formulations that have been studied and, importantly, the major gaps in knowledge,” said co-author Devan Kansagara, MD, MCR, professor of medicine at OHSU.

Source: Oregon Health & Science University

Access to Medical Marijuana Increases Risks for Abuse

Cannabis plants
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A study found that access to medical marijuana to treat pain, anxiety, or depression symptoms led to cannabis use disorder (CUD) in a significant minority of individuals while failing to improve their symptoms. The Massachusetts General Hospital (MGH) study was published in JAMA Network Open. 

In the US, individuals are able to gain access to cannabis products using medical marijuana cards (MMCs), usually issued by a doctor. Researchers found the greatest risk of developing the addictive symptoms of CUD was in those seeking relief from anxiety and depression. This finding indicates the need for stronger safeguards over the dispensing, use, and professional follow-up of people who legally obtain cannabis through MMCs.

“There have been many claims about the benefits of medical marijuana for treating pain, insomnia, anxiety and depression, without sound scientific evidence to support them,” said lead author Jodi Gilman, PhD, with the Center for Addiction Medicine at MGH. “In this first study of patients randomised to obtain medical marijuana cards, we learned there can be negative consequences to using cannabis for medical purposes. People with pain, anxiety or depression symptoms failed to report any improvements, though those with insomnia experienced improved sleep.”

Dr Gilman was particularly disturbed by the fact that individuals with symptoms of anxiety or depression – the most common conditions which people seek medical cannabis for – were the ones most vulnerable to developing cannabis use disorder. CUD symptoms include a vicious circle of needing more cannabis because of growing tolerance, and seeking out cannabis to treat the psychological problems it causes.

“Medical” cannabis has surged in popularity in the US, as so far 36 of its 50 states have commercialised its use for myriad health conditions through medical marijuana cards. These cards require written approval of a licensed physician who, under the current system, is often not the patient’s primary care provider but rather a ‘cannabis doctor’ who may provide authorisation to patients with only a cursory examination, no recommendations for alternative treatments, and no follow-up. The medical marijuana industry effectively functions outside the regulations that apply to most fields of medicine.

The researchers started their trial in 2017 with 269 adults (average age of 37) who were interested in obtaining a medical marijuana card. One group was allowed to get MMCs immediately, while the second group, designed to serve as a control, was asked to wait 12 weeks before obtaining a card. Both groups were tracked over 12 weeks. The team found that the odds of developing CUD were nearly two times higher in the MMC cohort than in the wait list control group, and that by week 12, 10% of the MMC group had developed a CUD diagnosis, with the number rising to 20% in those seeking a card for anxiety or depression.

“Our study underscores the need for better decision-making about whether to begin to use cannabis for specific medical complaints, particularly mood and anxiety disorders, which are associated with an increased risk of cannabis use disorder,” said Dr Gilman. Regulation and distribution of cannabis to people with medical marijuana cards needs to be greatly improved, no matter the specific condition they are issued for. “There needs to be better guidance to patients around a system that currently allows them to choose their own products, decide their own dosing, and often receive no professional follow-up care.”

Source: Massachusetts General Hospital

Guidelines for Cannabinoid Treatments in Drug Resistant Epilepsy

Cannabis plants
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Due to the sizeable interest in the use of cannabis-based medications in treating drug resistant epilepsy and comparative lack of clinical guidance on prescription, an expert working group in Australia recently developed an interim “consensus advice” for prescribers and published it in the British Journal of Clinical Pharmacology.

The working group was made up of paediatric and adult epilepsy specialists, clinical pharmacists, pharmacologists, and cannabis researchers. Epilepsy occurs in 1–2% of the population, and about one in three people with epilepsy are considered drug resistant to standard antiseizure medications.

Since there are few clinical data available on comparative efficacy of cannabinoids with registered epilepsy treatments, the authors recommend cannabinoids only in drug resistant epilepsy, in carefully selected compliant patients with specific epilepsy phenotypes.

The document provides an overview of the different cannabis medicines currently available for treating epilepsy in children and adults, with information on dose, drug interactions, toxicity, and type and frequency of symptom and seizure relief. The consensus advice will be updated as new evidence emerges and will provide the structure for a more definitive guideline in the future.

“In the absence of a registration dossier, scientific experiments and case reports are helpful to provide some guidance to optimised dosing. However as in this guidance, observational data obtained from clinical practice – which often includes information not included in scientific experiments or even early clinical trial data, such as treating patients with other comorbidities, taking multiple medications, and patient diversity – can be very helpful to clinical practice,” said senior author Jennifer H. Martin, MBChB, MA, PhD, FRACP, a researcher at the University of Newcastle and the Director of the Australian Centre for Cannabis Clinical and Research Excellence.

Source: Wiley