Canadian firms in line to supply psychedelics for Australia’s Authorized Prescriber Scheme

PharmAla Biotech – January 29, 2024

Australia is ramping up its Authorized Prescriber Scheme for psychedelic medicines, presenting a significant opportunity for Canadian biotechnology firms to supply it with safe and standardized good manufacturing practice-grade substances.

The Australian organization responsible for the regulation of therapeutic goods including drugs and medical devices, the Therapeutic Goods Administration (TGA), last year changed the classification of psilocybin and MDMA within the country’s Poisons Scheme to allow for them to be prescribed by authorized psychiatrists.

For this purpose, they are considered Schedule 8 Controlled Drugs but for all other purposes remain Schedule 9 Prohibited Substances.

Since July 1, 2023, specially authorized psychiatrists have been able to prescribe psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder.

Earlier this month, the co-founder of outpatient psychiatrist-led mental health organization Monarch Metal Health Group Ted Cassidy became the first doctor to prescribe MDMA psychedelic-assisted therapy for PTSD to a female patient under the Authorized Prescriber Scheme.

“I am proud that Australia has taken world leadership in translating psychedelic research into clinical reality,” he wrote in a post on LinkedIn.

Several Canadian psychedelics-focused biotech companies have already overcome the significant regulatory and logistical challenges surrounding the export of controlled substances like MDMA and psilocybin into Australia, paving the way for them to supply the nation’s scheme as more patients are prescribed these drugs to treat mental health conditions.

British Columbia-based Filament Health Corp earlier this month completed its first export of its botanical psilocybin drug candidate to its partner Reset Mind Sciences located in Perth, Western Australia.

The company is a longtime supplier of Canada’s Special Access Program, a framework which allows healthcare professionals to request access to non-marketed drugs not available for sale such as psilocybin or MDMA for patients with a serious or life-threatening condition on a case-by-case basis.

While Filament’s drug product will be used by Reset for research purposes, the export, which is believed to be the first export involving botanical psilocybin into Australia, demonstrated the company’s regulatory capabilities.

Reset is advancing a GMP licence application to manufacture psilocybin products from botanically sourced psilocybin for human consumption as it awaits the publication of the TGA’s order governing psilocybin production in Australia, Filament highlighted.

“We are closely monitoring the Authorized Prescriber Scheme, and we commend the TGA for including botanical products in their draft guidance for the products,” a Filament Health spokesperson told Proactive.

Another Canadian firm working to supply Australia’s scheme is PharmAla Biotech, a company focused on the manufacturing of novel MDXX class molecules including MDMA.

In November, PharmAla announced it had completed its first shipment of MDMA and psilocybin to Cortexa, its Australian joint venture with Vitura Health Limited.

This marked the first time that these drugs have been brought into Australia specifically to be used under the Authorized Prescriber Scheme rather than for clinical trial purposes, the company said.

Drug manufacturer Optimi Health Corp through a partnership with Mind Medicine Australia (MMA), an Australian mental health charity and provider of psychedelic-assisted therapy training, is positioned to be another supplier of the scheme.

Through this partnership, announced in March 2023, Optimi is contracted to supply its MDMA formulation PTI-MHCL and GMP psilocybin capsules to MMA on an ongoing basis.

In a November 2023 shareholder update, Optimi said it continues to collaborate with MMA to navigate intricacies related to the scheme.

It noted that once a psychiatrist has received approval from the TGA to become an authorized prescriber it can apply for an import permit for Optimi’s drug candidates. The approval of such a permit can take up to 45 days after which Optimi will initiate the shipment of the drugs to Australia.

Story from – Proactive Investors


CASE NUMBER: 23-771501
Hamilton October 6, 2023

Two Illegal Psilocybin Store Fronts Closed Permanently the Mushroom Cabinet and Shroomyz …
Hamilton Police have permanently closed the doors on two illegal psilocybin businesses that were the subject of previous police warrant executions.

On Friday, October 6, 2023, Hamilton Police shut down two illegal psilocybin stores permanently. The Mushroom Cabinet and Shroomyz are now closed, with cooperation from landlords, the locks have been changed and Hamilton Police signage installed indicating that any entry could result in Break and Enter or other applicable charges.

Hamilton Police have charged, a 35-year-old male in relation to the Mushroom Cabinet with CDSA 5(2) Psilocybin and Proceeds of Crime Under $5000.

The following was seized from the Mushroom Cabinet;

  • 1.3 kilograms of dried Psilocybin
  • 33 bottles containing 20 capsules of Psilocybin in each (660 capsules total)
  • 30 Psilocybin chocolate bars
  • 25 Psilocybin chocolate squares

Hamilton Police have also charged, a 50-year-old female in relation to Shroomyz with CDSA 5 (2) and Proceeds of Crime Under $5000.

Shroomyz
The following was seized from Shroomyz;

  • 404 packages of dried Psilocybin (2.83 kilograms total)
  • 308 chocolate cars 3.5 grams each bar (1.08 kilograms total)
  • 713 bottles containing 14260 capsules total (3.5 kilogram total)
  • 19 jars of Psilocybin butter
  • 228 packages of gummies each containing 4500mg (1 kilogram total)

In total, Hamilton Police have seized 9.71 kilograms of dried psilocybin with a street value of $97,100.

A third store, Shroom Godz, opened yesterday directly across the street from the Mushroom Cabinet. Police have since informed the owner of Shroom Godz of the recent measures implemented on the two neighbouring businesses and the owner has made a decision to cease operations.

Hamilton Police remind the public that psilocybin remains a schedule III drug and a restricted substance under the Controlled Drugs and Substance Act (CDSA). Psilocybin is illegal to possess and at this time, there are no legal licensed options available, under which psilocybin dispensaries are allowed to operate.

If you have any information that you believe could assist Police with the investigation into this crime, please contact Detective Sergeant Greg Slack at 905-546-3810.

To provide information anonymously call Crime Stoppers at 1-800-222-8477 or submit your anonymous tips online at http://www.crimestoppershamilton.com

MAKE YOUR VOICE HEARD!

Story  from Hamilton Police website


I Went to Rehab for Alcoholism 18 Times. Only Psychedelics Helped

By Lidia Polito August 16, 2023

A version of this article originally appeared on VICE Germany.

I met Amanda at a pain therapy clinic in Zurich last December. She was sitting on a chair, hands folded neatly in her lap – she’d come here with her husband Tim for one of her regular visits to neurologist Livia Granata, one of the few specialists in Switzerland offering psychedelic therapy.

For the past seven years, Amanda hasn’t lived in her flat with her partner and their children, but outside on the balcony. She stays in an improvised shelter her husband made for her, only going in to use the toilet – and the pandemic only further tightened the grip her anxiety disorders have on her life.

A year ago, Amanda probably wouldn’t have shown up for this appointment at all, either cancelling at the last minute or simply letting it pass. Over the years, she’s been through too many treatments – experimental therapies that brought little to no relief. But in April 2022, she found her way to the clinic – and to the first treatment she felt ever truly worked.

About 30 percent of depression patients experience treatment-resistant depression, meaning an illness that doesn’t improve with traditional psychiatric therapy. In 2022, a study of 79 patients with treatment-resistant depression found that a single dose of psilocybin (the psychedelic compound in magic mushrooms), accompanied by immediate therapy, improved a third of the participants’ mood. These promising results contribute to a growing body of evidence that psychedelics might present an important tool for treating mental disorders.

The first studies looking at psychedelic therapy date back to the 50s and 60s, but research projects were shut down in the two decades that followed as psychedelics became increasingly criminalised. One of the countries that contributed most to this research is Switzerland, where psychedelic therapy was briefly legalised between 1988 and 1993 and used to treat almost 200 private patients.

Research began again in the early 2010s and, since 2014, doctors can apply for an exemption with the Swiss government to administer otherwise illegal substances like magic mushrooms, LSD and MDMA to patients. Dr. Granata has been granted a licence to do this for a year and has treated 20 people with psilocybin over this period.
Most of her patients come to her practice for chronic painmigraines, cluster headaches, phantom pains. Our scientific understanding of why exactly psychedelics work is still unclear, but studies have shown that they probably help with brain plasticity, meaning they can stimulate neurons into forming new connections which in turn reorganises thought patterns.

“I was a functional alcoholic,” said Amanda, recalling the first years of her addiction. “I only drank in the evenings, but I drank way too much and it was starting to affect my family life.” In the beginning, alcohol helped her escape unwanted thoughts, but that soon stopped being effective. She kept drinking anyway.

In 2007, Amanda realised she had a problem and decided to seek help. But her children were little at the time and she couldn’t bear the thought to leave them for long stretches of time. Over the intervening years, she’s visited rehab centres and psychiatric clinics over and over again – 18 times in total, some for a few weeks, others for months. She was often institutionalised with people with severe and diverse mental health conditions, and that made her feel unsafe. Sooner or later, she’d relapse. “Even though I was there voluntarily and I could ask to go out, it was just the feeling of being locked in [that scared me],” she remembers.

As time went on, Amanda became suicidal because she “couldn’t beat this thing”, as she puts it. Her attempts at suicide – 12 in total – caused her to be forcibly committed, fuelling the cycle of failed therapies and making her sicker and sicker.

Her last hospital stay in the summer of 2021 made it clear to her she never wanted to go back to a psychiatric ward again. “I’d lost a lot of weight, it went down to 50kg,” she says. “I’d just had enough.” Then, she came across a documentary about a study in Switzerland where alcoholics are treated with psychedelics. She signed up to participate and was referred to Livia Granata.

Initially, the two tried a course of therapy involving ketamine IVs. Ketamine is an anaesthetic used in emergency care and as a recreational drug, but has psychedelic effects. It’s also been shown to be an effective antidepressant and anti-suicidal drug, and particularly good with cases of treatment-resistant depression.

Amanda received infusions on four consecutive days. She lost consciousness, had wild hallucinations and called out for her husband in fear. Still, after the sessions, there was hardly any change in her mental state. 

Then Granata decided to try administering her psilocybin – 20 milligrams per session at first, then 30 because she “tolerated it extremely well”, Granata says. They did six sessions of about eight hours, or until the psychedelic high was over. Granata and her team are not therapists – they simply supervise Amanda while she listens to music, lies down on the couch or the carpet, puts a mask over her eyes and just gives in to the feeling.

Many patients cry during treatment, says Aisha Savdi, a medical assistant in the team. Some want to be held, others want to be left alone. The sessions often bring up past memories and emotions that have been repressed. Many report that they look at their lives like an outsider. Things become clearer; perspectives change.

For Amanda, the hallucinogenic effect was weaker than with ketamine. The lights were slightly blurred, but above all, she felt good: relaxed, anxiety gone. “Tim had trouble getting me back to the car, because I was looking at all the bright colours like a kid,” she says. “It certainly changed my attitude a bit, I feel the weight lifted.”

Since then, she and the people in her life have observed a huge improvement in her severe depression and anxiety. Although she still can’t bear to move out of the balcony, she’s been able to leave her house, visit the hairdresser, go on a walk or to see a friend. She can watch some videos explaining childhood trauma without shutting down. “My mind seemed more open so I could really take it in,” she explains.

Last September, Tim and her were even able to go on holiday for the first time in years, “to Greece, to our favourite spot that we used to go to every year,” Tim recalls. “Yeah, that was a pretty big thing.” 

And something else is different, too – her urge to drink is gone. She has been abstinent since April 2022 – her longest time without alcohol in 20 years. Granata has prescribed a ketamine nose spray to help with the cravings, which sometimes still happen, especially when something changes in her life. The holiday was challenging, for instance – but so far, she’s been able to swerve drinking.

“I haven’t gone back to that place [of addiction and depression]. Well, briefly, but not a really bad place,” Amanda said. Four months after the initial treatment, her mood dipped again, so Dr Granata decided to give her a booster, starting a new course of therapy in September 2022. Amanda has also been on the hunt for a trauma-informed therapist to explore talk therapy while high.

Granata is very impressed with her progress, especially given her history of psychiatric interventions and drug courses. “Using this substance four to six times has managed to achieve [for Amanda] what the other therapies didn’t do in years,” she says. “That’s what’s special about these drugs – how quickly they work and how long-lasting their effect is.”

Although things are still difficult, her partner Tim has seen a marked improvement in Amanda’s mood, in her ability to go do things, get to appointments and be present for her family. No matter the final outcome of the treatment, he believes this type of therapy is much better than the traditional methods that Amanda has used. He remains hopeful for her and their lives together; as he puts it: “I’m a born optimist.”

Story from – Vice

PSYCHEDELICS CAN RELIEVE CHRONIC PAIN, NEW SURVEY SUGGESTS

A survey of 170 volunteers found chronic pain was relieved by both macro- and microdoses of classic psychedelics including LSD and psilocybin.

More research is emerging that suggests chronic pain may soon be added to the long list of medical conditions psychedelics can relieve.

A new study published in the European Journal of Pain last month found that both macro and micro doses of classic psychedelics — LSD, psilocybin, DMT, mescaline — led to better pain relief compared to conventional medication in volunteers surveyed.

“Participants reported that full doses seem to achieve better perceived results in pain relief than microdosing, while microdosing’s effectiveness seems comparable to that of conventional medication according to survey participants,” the paper concluded.

Researchers focused on five conditions: fibromyalgia, arthritis, migraine, tension-type headache and sciatica.

Four of those five, with sciatica being the exception, were reported to be relieved by psychedelics on the dosage day, as well as 1-3 days after, with a few even reporting pain relief beyond the third day.

Psilocybin and LSD were the most common drugs used in this survey of 170 participants.

“The effect of psychedelics on pain related to sciatica was statistically non-significant,” researchers wrote. “This result may indicate that these substances hold promise only for certain kinds of pain conditions, presumably those in which the inflammatory and/or psychosomatic components play a more prominent role.”

Though data obtained from this survey is promising, echoing previous results from researchers investigating psychedelics’ effect on chronic pain — an issue impacting 20 percent of the world’s population — study authors acknowledge a number of limitations, with the biggest being design.

“It provides purely retrospective self-ratings from a self-selected sample of individuals who self-administer psychedelics,” the paper notes. “This design carries the risk of obtaining biased data and the generalizability of the produced results is only limited. It provides limited information to disentangle the role that different mechanisms play to achieve these perceived analgesic effects.”

Authors acknowledged controlled studies are needed, and recommend researchers design clinical trials to explore further.

Amanda Feilding, founder and director of the Beckley Foundation, initiated the survey after establishing The Beckley/Maastricht Microdosing Research Programme, which is dedicated to studying the effects of microdosing LSD on mood, cognitive functions, and pain management in humans.

The program’s previous placebo-controlled clinical study of 24 healthy volunteers found that a 20 microgram dose of LSD significantly reduced pain perception, as compared to the placebo, during cold pressure tests. “I am encouraged by these results as I have long believed that LSD may not only change the sensations of pain but also our subjective relationship with it,” she said after that study was published in 2020. “We must continue to explore this with the aim of providing safer, non-addictive alternatives to pain management.”

As Psychedelic Spotlight previously reported, MindMed is also exploring LSD for chronic pain treatment, while Imperial College London researchers found in 2021 that nine out of 11 chronic pain sufferers self-medicating with psychedelics reported complete, or at least partial, analgesia during their dosage experience.

More recently, a 9/11 first responder advocating for California lawmakers to decriminalize psychedelics, shared that psilocybin healed his PTSD as well as debilitating cluster headaches. “I stopped taking the cocktail of pills I had been prescribed, many of which caused damaging side effects and were addictive,” he wrote, adding: “It’s not an exaggeration to say that psilocybin gave me my life back. It’s been transformative, and allowed me to feel happiness and joy in a way I never thought I would again.”

Story from – Psychedelic Spotlight


Alison speaks at a Toronto Psychedelic Community event at Lost Craft Brewery – February 24, 2023


Mental health treatments: Australia OKs MDMA, psilocybin, but what does this mean?

By Katharine Lang on February 10, 2023 — Fact checked by Harriet Pike, Ph.D.

Psilocybin, the psychoactive substance in so-called magic mushrooms, and MDA will become legal in the treatment of some mental health conditions in Australia

  • Post-traumatic stress disorder (PTSD) and major depressive disorder do not always respond to therapies or medication.
  • In the hunt for effective therapies, the Australian government has authorized the use of psychedelics for these severe mental health issues.
  • Under strict controls, Australian psychiatrists will be able to prescribe medicines containing MDMA for severe post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression from July 2023.
  • Medical News Today asked experts in the United States and the United Kingdom for their reaction to the decision.

PTSD is a mental health condition that may occur after someone has gone through a traumatic experience. According to the U.S. Department of Veterans Affairs, symptoms — including flashbacks, negative thoughts, and sleep disturbances — can have a major impact on a person’s life.

For some people, PTSD resolves through talking therapies, medication, or both, but for others, treatment is ineffective.

Depression that does not respond adequately to treatment with standard anti-depressants is known as treatment-resistant depression. It is relatively common, occurring in up to 60% of people treated for depression.

Dr. Adrian Jacques H. Ambrose, senior medical director of the Department of Psychiatry at Columbia University Irving Medical Center, told Medical News Today just how important it was to find new treatments.

“According to some studies, a significant portion—approximately half—of the patients with severe psychiatric conditions like PTSD or MDD [major depressive disorder] don’t respond to FDA-approved treatments, like SSRIsTrusted Source,” he noted.

Australian decision

On February 3 this year, the Australian Therapeutic Goods Association (TGA) published its decision to authorize the use of MDMA for PTSD that has not responded to treatment, and psilocybin for treatment-resistant depression from July 2023. Both are substances that are, under any other circumstances, illegal.

“There have been a growing number of studies indicating that these psychedelic compounds — specifically MDMA for PTSD and psilocybin for MDD — may help patients who have severe symptoms and may not have previously responded to traditional treatments.”

– Dr. Adrian Jacques H. Ambrose

The decision has raised some concerns, as Dr. James Rucker, consultant psychiatrist and senior clinical lecturer at King’s College London in the United Kingdom, told MNT.

“Some important caveats apply here,” cautioned Dr. Rucker. “The main one is that the drugs are subjectively noticeable to participants in clinical trials.”

“This means that the placebo response is likely to differ between groups, and this may account for some of the improvement. It is very hard to account for this. The interaction is likely to be complicated. There is promise here, but much uncertainty,” he pointed out.

And Dr. Ambrose also urged caution: “I think it’s a difficult balancing act. On one hand, there’s a lot of real suffering for patients for whom traditional treatments didn’t fully address their psychiatric symptoms. On the other hand, I hope that we — both the scientific community and the patient populations — can temper our zeal and proceed with all the due diligence to ensure that we fully know the risks and benefits of these compounds.”

What are the treatments?

3, 4-methylenedioxy-methamphetamine — the scientific term for MDMA, also known as “ecstasy” — is a synthetic drug that is often used recreationally. Psilocybin is the hallucinogenic substance found in certain mushrooms that grow in Europe, South America, Mexico, and the U.S. — commonly known as “magic mushrooms.”

In authorizing their use in targeted treatments, the TGA stated: “The decision maker recognized there is a need for access to new therapies for treatment-resistant conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Psychotherapy involving psilocybin and MDMA has shown to be potentially beneficial in the treatment of these conditions.”

Use of both MDMA and psilocybin is prohibited in AustraliaTrusted Sourcethe U.S., and the U.K. Following this decision, medicines containing these substances will be legally used in Australia in strictly controlled medical settings as of July 1, 2023.

Was the decision premature?

The TGA based its decision on evidence from clinical trials, stating that “there is now sufficient evidence that psilocybin and MDMA will potentially be effective in the treatment of treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively, for certain patients. In particular, clinical trials have shown promise when they are used in combination with psychotherapy conducted in strictly controlled medical settings.”

However, Dr. Rucker expressed some misgivings:

“Such decisions short circuit the clinical trials process itself and undermine the whole principle of evidence-based medicine. Where is the motivation to do good quality research into efficacy and safety if a regulator just approves it before such research is complete?”

“From a pharmaceutical company’s perspective, why would they research it if it has already been approved (this is exactly what has happened with medical cannabis)? What message does that send to the field as a whole? This is a slippery slope and a dangerous precedent, I fear,” he told us.

Dr. Ambrose added a note of cautious optimism: “As we continue to expand our research in better understanding the short-term and long-term effects of psychedelics, I hope that we can continue to dialectically hold the balance: the rigorous scrutiny of clinical research and the unifying goals of helping patients with treatment-resistant mental health conditions who are hurting and need effective treatments.”

Benefits and risks

MDMA and psilocybin have known side effects, which Dr. Rucker described:

“Both have their dangers, but within a medically controlled setting these can be minimized. MDMA can cause raised blood pressure and heart rate and, rarely, produce ‘serotonin syndromeTrusted Source,’ which can be dangerous. Psilocybin is quite safe from the perspective of the body, but it can induce panic and paranoia in some people. If this is not managed by skilled psychological support practitioners it can lead to a worsening of someone’s condition.”

Dr. Keith Heinzerling, internist, addiction medicine specialist, and director of the Treatment & Research in Psychedelics Program for the Pacific Neuroscience Institute in Santa Monica, CA, was more optimistic about the use of psilocybin.

“Possible benefits of psilocybin therapy, as opposed to traditional existing treatments, include that treatment may only require a few doses of psilocybin, with counseling and support in between sessions, as opposed to most current medications that are taken daily for the long term,” he told us.

“Also the model of psychedelic therapy is very patient-centered and may help patients to feel more empowered by the treatment,” added Dr. Heinzerling.

He did, however, urge caution: “Patients at high risk of psychoses should not take psilocybin and there are medications — some antidepressants and other medications that affect serotonin — that should not be combined with psilocybin.”

Will other countries follow suit?

The U.S. state of Oregon legalized the therapeutic adult use of psilocybin on January 1, 2023. In Canada, designated physicians can prescribe it for those with severe treatment-resistant depression. In both, the drug is still illegal outside specific therapeutic settings.

There are, as yet, no plans to authorize the use of MDMA or psilocybin in the U.K., but psychiatrists there will be watching the Australian experience closely.

Dr. Trudi Seneviratne, registrar at the Royal College of Psychiatrists, commented: “We are confident that Australian regulators will have ensured the appropriate safeguards are in place for its use and that this will provide important data on the effectiveness of the drug.”

And, as Dr. Ambrose told us, the rest of the world will also be watching:

“I appreciate that [the Australian government has] set up specific restrictions—limiting the prescription to psychiatrists who spent years training to treat psychiatric conditions and having the approval of a human research ethics committee. I think the rest of the world will be looking at the clinical outcomes from the Australian government’s decisions.”

Read more –

In Conversation: Can psychedelics rewire a depressed, anxious brain?

Growing research into hallucinogenic drugs is demonstrating that—contrary to what was previously believed—depression and anxiety cannot be reduced to a simple equation of chemicals in the brain. So, will psychedelics be able to bring a decisive paradigm shift to how we view and treat these mental health conditions?

According to the World Health Organization (WHO), more than 300 million people worldwide are estimated to experience depression and a similar number of people are thought to live with anxiety. As people often experience such mental health conditions simultaneously, which is referred to as comorbidity, and many do not seek treatment, the real number likely is a lot higher.

Until now, researchers’ approach to treating anxiety and depression has largely focused on striking a delicate balance between chemical messengers in the brain. The plethora of medications prescribed, such as SSRIs (selective serotonin reuptake inhibitors)Trusted Source all work around that principle.

Studies on hallucinogenic compounds, however, have shown that such drugs can help the neurons in the brain “talk with each other” via neurotransmitters, or chemical messengers. This has led to the emergence of the “network theory.”

“There really has been almost like a paradigm shift in the way that we looked at the pathophysiology of depression; it used to focus on chemical imbalance. Now, it has shifted to look at it a little bit more as a disorder of synaptic plasticity, as well as neural interconnectivity.”
— Dr. Adrian Jacques Ambrose, adult, child/adolescent psychiatrist

In the latest episode of our In Conversation podcast, we discuss the newest research into the neuroscience of anxiety and depression and how this may change the future of treatment with Dr. Adrian Jacques Ambrose, medical director of the Columbia Psychiatry Practice Office. Dr. Ambrose also specializes in interventional neurotherapeutic psychiatry, working with ketamine, electroconvulsive therapy (ECT), and transcranial magnetic stimulation (TMS) in the treatment of resistant mood disorders.

Our other interviewee is Olivia, who has been living with anxiety and depression for a number of years, and she shares her experience.

You can listen to our podcast in full below, or on your preferred streaming platform.

Describing difficult feelings

Our conversation starts with spotting the signs and symptoms of these conditions. On talks of anxiety, Olivia chimes in:

“[When anxious] I can feel like butterflies inside and my hands are sweaty, and you just feel very, I don’t know, on edge. But then with panic attacks or anxiety attacks, I get very hyperventilated and struggle to breathe.”

In contrast, Olivia says, depression makes her feel very different emotions.

CRIPPLING DEPRESSION – “For me, very obviously it’s a low in mood. I feel worthless, and then have periods where I find it hard to get out of bed, be motivated. It’s like, being weighed down. you want to come up, but you can’t.”
— Olivia, who has experienced depression for many years

“When you’re depressed, you kind of feel a bit numb, I find that it’s very different compared to anxiety. You just feel empty rather than on edge. They’re very different ends,” she said.

A changing brain

Without treatment, depression and anxiety disorders can alter the way the brain functionsTrusted Source, and cause physical changes.

For example, with prolonged episodes of anxiety, the amygdala, or the tiny almond-shaped center of emotions and motivation, grows larger and becomes hypersensitive. The stress caused by constant anxiety also shrinks the hippocampus, the structure involved in learning and memory.

These physical changes can also bring about more psychological symptoms or worsen them.

During anxiety, the constant “danger” signaling to the hypothalamus—the smart control and coordination center deep in the brain—also eventually weakens the connections between the amygdala and prefrontal cortexTrusted Source, which is responsible for planning, and decision-making. As a result of this chain of reactions, an individual may start to lose their ability to think analytically or logically.

“For example, in [depressed] adults, we see abnormally increased amygdala, as well as ventral striatal and medial prefrontal cortex activity. What that means is that the patients are more attuned toward negative emotional stimuli. They also show abnormally reduced ventral striatal activity toward positive emotion and emotional stimuli,” said Dr. Ambrose.

The pathophysiology of anxiety and depression

One of the earliest hypotheses about the pathophysiology of depression is that it was an imbalance of chemicals in the brain. But, in reality, it is a rather complex interplay of multiple factors. Similar theories have been put forth for anxiety as well. ResearchTrusted Source has implicated biochemical imbalances and an often-inherited defensive mechanism in the brain.

“Our prior understanding of [depression and] anxiety disorders primarily focused on neurotransmitters because those were what we used SSRIs for in order to treat these conditions,” said Dr. Ambrose explaining the current approach.

Newer studiesTrusted Source instead have found dysfunction in neural circuits to be a factor, with researchers identifying “hot and coldTrusted Source” areas within the brain.

With regard to circuitry affected by depression and anxiety, Dr. Ambrose said there are different aspects of the brain that get hyperactivated and hypoactivated.

“For anxiety disorder, as well as panic disorder, there’s hyperactivation of what we call the fear network. [By this] I mean specific parts of the brain that includes the thalamus, the amygdala, the hippocampus, and the striatum,” he said.

Dr. Ambrose said this fear network essentially magnifies some of the sensory inputs a person may be experiencing during anxiety attacks. As the human brain is wired to hold onto negativeTrusted Source memories and emotions, such as those of fear, failure, and danger, these keep replaying in the mind.

“In panic disorder, you get this overdrive of fear and over-evaluation of fear by the orbital frontal cortex, which is the part of the frontal lobe of the brain that is involved in the cognitive process of decision making. So, it makes you feel very fearful when you have to make decisions that appear to be a threat,” he further explained.

“When in objective evaluation, it may not necessarily be a threat, but you perceive it as a threat,” he added.

Current treatments

In evaluating all the medications currently used to manage and treat anxiety and depression, three classes of drugs stand out from the rest.

Tricyclic antidepressants, also known as TCAs, are the oldest class of antidepressants and were introduced in the late 1950s. However, they were often associated with many side effects.

Apart from talking therapy, the next most popular first line of treatment is SSRIs, which are drugs that act on serotonin molecules and manipulate their level to indirectly boost other neurotransmitters. The FDA approved them in the 1980s. One of the most widely used SSRIs is fluoxetine, more commonly known under the brand name Prozac.

The latest addition to the modern era of antidepressants came in the 90s with SNRIs (serotonin-norepinephrine reuptake inhibitors), with medications such as venlafaxine (Effexor). These were deemed a lot safer in terms of side effects.

As for anxiety, short-term treatment includes calming drugs like benzodiazepine and psychotherapy. In the longer term, doctors often prescribe antidepressants and anti-anxiety drugs like buspirone.

However, research has indicated that antidepressants may only improve symptoms in about 40% to 60%Trusted Source of people.

“For major depressive disorder, unfortunately, what we find is that antidepressants are not as effective as we would hope. So roughly, [half] of patients will say that their antidepressants don’t really work well for them. And even after multiple medication trials, about a third of patients will still show no response to antidepressant trials,” said Dr. Ambrose.

Psychedelics enter the scene

The term psychedelic comes from “psyche” and “dēlos”, Greek for “mind-manifesting.” It was coined in the 1950s by British psychiatrist Humphry OsmondTrusted Source.

When one talks of psychedelics, they refer to drugs and psychoactive substances that invoke a certain type and extent of experience. Some examples are LSDTrusted Source (lysergic acid diethylamide, or acid), psilocybin (magic mushrooms), and DMT (dimethyltryptamine).

If we were to compare regular antidepressant medication with psychedelics, the most apparent difference would be in their mechanism of action.

Antidepressants work by manipulating the levels of neurotransmitters that are typically too low (or too high) in the brains of people experiencing depression or anxiety. Meanwhile, psychedelics act on neural circuits, stimulating, suppressing, or modulating the activity of the networks that use serotonin.

One of the advantages of using psychedelics in depression or anxiety treatment, as studies have shown, is that researchers have managed to improve or get rid of symptoms with just a few usesTrusted Source, particularly with psilocybin. Antidepressants, on the other hand, usually have to be taken every day for months or years.

One such study was a randomized clinical trialTrusted Source involving 24 participants with major depressive disorder. The participants who received immediate therapy with psilocybin (in addition to psychotherapy) had less severe depressive symptoms compared to those who received delayed treatment. By the 4th week after initial treatment, 54% of the participants were no longer classified as depressed.

Researchers have also found that psychedelics can increase neural connectionsTrusted Source in the brain.

“I think that antidepressants are not as efficacious because of their lack of specificity. We don’t necessarily have the current technology to be really targeted in the way that we’re using psychopharmacologic treatments,” said Dr. Ambrose.

Why ketamine may be different

Ketamine is, first and foremost, an FDA-approved anesthetic and dissociative drug. While it does produce similar effects as psychedelics and leads to a similar expanded state of awareness, it has a different mechanism of action. In that sense, some researchers refrain from labeling ketamine as a classic psychedelic.

Ketamine works by relaxing the brain’s inhibitory architecture, whereas psychedelics work by overridingTrusted Source this system.

Due to this mechanism, many people describe their experience with psychedelics as challengingTrusted Source and powerful, either constructive or destructive, depending on the settings and individual circumstances. With ketamine, participants in trials describe it as a gentler experience in comparison.

However, animal studiesTrusted Source have also found that ketamine may require more regular intake to prolong its anti-depressant effects, raising concerns around addiction.

A new age of consciousness medicine?

Mounting evidence is suggesting that hallucinogenic drugs can be effective therapies for treatment-resistant depression and anxiety. A renewed understanding of the neuroscience behind anxiety and depression is also prompting researchers to rethink such therapies for these conditions.

Dr. Ambrose said that as technologies such as neuroimaging and functional MRIs get more advanced, it is becoming clearer to see the areas of hypoactivation and hyperactivation in the brain as well as areas that might be a little bit more sensitive when people are experiencing conditions like anxiety.

As with any type of medication, each has its own set of benefits and risks. This rings true for non-conventional therapies like hallucinogenic drugs as well.

Psychedelics may hold the potential to “open up” people’s brains, helping it become more flexible and fluid. Dr. Ambrose said that they may be best for people with treatment-resistant mental health conditions who have failed to gain positive results from a variety of treatments.

The only way to get access to these treatments, currently, is through clinical trials, where rigorous safeguards are in place. Every individual’s needs may also be differentTrusted Source depending on their personality, circumstances, and health conditions.

“As a physician, I want to be really agnostic in the space and let the clinical evidence really speak for itself. I don’t want to quit any judgment surrounding psychedelics or any particular predilection.My main focus is trying to be mindful of potential.”
— Dr. Adrian Jacques Ambrose

Dr. Ambrose said he saw psychedelic therapy as an additional tool to current treatments.

“It’s not meant to be a panacea. I think just trying to be mindful of the fact that there are, unfortunately, a lot of social and sociological traumas like poverty and racism [surrounding such treatments and therapies] that it’s really hard to treat with a medication or a pill,” he added.

For the foreseeable future—whether due to a lack of resources or technology, or stigma—it is unlikely that psychoactive compounds will become mainstream treatments for mental health conditions.

However, interest in ketamine and psychedelics as treatment avenues for anxiety and depression is likely to grow.

What to know about psychedelic therapy

Psychedelic therapy is the use of plants and compounds that can induce hallucinations to treat mental health diagnoses, such as depression and post-traumatic stress disorder (PTSD).

Some of the compounds that doctors most frequently use in this form of treatment include psilocybin mushrooms, LSD, and mescaline (peyote). The formal study of psychedelics to treat mental health conditions is relatively new, but emerging research suggests that these psychedelics may help some people with some symptoms, especially when other methods of treatment have failed.

Researchers do not know exactly how or why psychedelics work in this manner. They may “reset” the brain by altering neurotransmitter levels, induce a new perspective on life by causing a person to have a mystical experienceTrusted Source, or teach a person a new way of thinking. Some research also suggests these psychedelics increase suggestibility, making a person more open to ideas discussed in therapy.

Keep reading to learn more about psychedelic therapy, including more about the conditions it may benefit, the types of treatment, and how it may work.

What is it?

Psychedelic therapy uses psychedelic plant compounds that can induce hallucinations, such as LSD and psilocybin from “magic” mushrooms, to treat mental health issues.

Sometimes doctors prescribe this treatment on its own. Often, though, they combine it with other treatments, such as therapy or other forms of support. The goal of psychedelic therapy is to increase the success of traditional treatments.

In many cases, doctors try this form of therapy on people whose symptoms have not responded well to standard medications or therapies.

How does it work?

Traditional medications for mental health conditions often take several weeks to work, or may only work for as long as a person takes them. Most research on psychedelic therapy, by contrast, has found an immediate improvement, often with a single dose.

Researchers do not know exactly how psychedelics work, and these drugs do not work for everyone. Some potential ways they might work include:

  • Mystical or psychedelic experiencesIntensely meaningful experiences under the influence of psychedelics may shift a person’s mindset or belief system, causing them to think or behave differently.
  • Increased suggestibility: People using psychedelics may be more suggestible. This can make them more responsive to positive suggestions from a therapist, or to the benefits of their own hallucinations.
  • Neurotransmitter changes: Neurotransmitters are chemical messengers in the brain. Many mental health drugs act directly on neurotransmitters to change mood. Certain psychedelic drugs also may act on neurotransmitters, changing the brain’s behavior and improving mood.

Types

Doctors can use many different drugs in psychedelic therapy, though most recent research has looked at psilocybin, a substance found in psychedelic mushrooms. Learn more about psilocybin here.

Some other drug options includeTrusted Source:

  • LSDA chemical found in several plants
  • DMTA chemical available in some plants
  • MDMA: Found in the sassafras tree, and known for its role in the drug Ecstasy
  • Mescaline: found in some cacti, such as the peyote cactus

Psychedelic therapy remains an experimental treatment, which means that people can usually only access this treatment via clinical trials. Some types of psychedelic therapy include:

  • Drug-assisted therapy: This is when a provider offers traditional treatments, such as psychotherapy, alongside psychedelics.
  • Psychedelics alone: A provider might only give a person a psychedelic drug, with no additional treatment.
  • Guided therapy: In some forms of psychedelic treatment, a person guides a person through the psychedelic “high,” offering therapeutic suggestions and helping the person remain calm.
Uses and benefits

Below are some potential health benefits of psychedelic therapy:

Terminal illnesses

Facing a serious or deadly diagnosis can be scary, especially if a person feels anxiety about death itself or what might happen afterward. A handful of studies suggest that psychedelic therapy may ease this existential dread, as well as the anxiety and depression that accompany it.

A 2016 study of 29 people with cancer who had anxiety or depression related to their diagnosis compared those who got a single dose of psilocybin mushrooms to those who got a placebo. The psilocybin reduced cancer-related anxiety, hopelessness, and dread immediately after the dose. At 6.5 months, 60 to 80% of the psilocybin group continued to report improvements in depression and anxiety.

Another 2016 study of 51 people with life-threatening cancer arrived at similar conclusions. Participants either took a dose of psilocybin or a placebo-like low dose of psilocybin. The high-dose psilocybin group reported significant improvements across many domains of functioning, including improvements in mood and relationships.

These improvements persisted for 80% of participants when researchers followed up 6 months later.

In both studies, participants reported mystical experiences, or spiritualistic experiences. These may help a person glimpse death, feel like everything is connected, or better envision their version of the divine. These experiences, both studies found, mediated rates of anxiety and depression. This suggests mystical experiences may play a role in the mental health benefits of psychedelics.

Depression and anxiety

Psychedelic therapy may also ease symptoms of depression and anxiety in people not facing serious illnesses.

A 2020 reviewTrusted Source reported on 24 prior studies on psychedelic drugs to treat anxiety symptoms. It said 65% of studies reported a reduction in anxiety with psychedelics, though the studies were small and some had methodological flaws.

A 2021 study asked 164 people who reported experiencing a psychedelic experience to discuss their mental health symptoms. Participants reported significant reductions in depression, anxiety, and stress following the psychedelic experience. An analysis revealed that participants also had greater compassion and less frequent rumination.

However, because the study relied on self-reporting, it does not conclusively prove that psychedelic experiences can affect mental health. Rather, it suggests a mechanism through which psychedelics might improve mental health, which is in feeling greater self-compassion and less obsession with negative thoughts.

A 2017 study looked at people with treatment-resistant depression. Researchers gave 20 people with mostly severe depression two doses of psilocybin 7 days apart, then followed up with them for 6 months.

Researchers observed a significant reduction in symptoms for the first 5 weeks following treatment. At 5 weeks, nine participants had responded to treatment, and four had depression that was in remission. Participants were more likely to have improvements in their depression symptoms if they had quality psychedelic experiences during the drug dose.

Post-traumatic stress (PTSD)

The psychedelic effects of hallucinogenic drugs may help ease the effects of trauma, but research so far has produced mixed results.

A 2020 systematic review looked at four studies of MDMA and five studies of ketamine for the treatment of trauma. The evidence supporting ketamine alone was very low, while the evidence for ketamine with psychotherapy was low. Researchers found moderate evidence supporting the effectiveness of MDMA.

Another 2020 study followed gay male survivors of the AIDS pandemic who reported feeling demoralized. Participants attended eight to 10 group therapy sessions, and got one dose of psilocybin. At 3 months, researchers found clinically significant reductions in participants’ symptoms of demoralization.

Addiction

An emerging body of research suggests that psychedelic therapy may help ease some symptoms of addiction. Addiction and other mental health symptomsTrusted Source, such as depression, commonly occur together, which may help explain the benefits. Perhaps by reducing other mental health symptoms, psychedelics make it easier to quit abusing substances.

A 2015 proof-of-concept study recruited 10 volunteers with alcohol addiction to undergo psilocybin therapy along with a type of psychotherapy called motivational enhancement therapy. In the first four weeks, during which participants only received psychotherapy, alcohol use did not decrease. After taking psilocybin, though, participants drank significantly less.

Participants who had intense psychedelic experiences were more likely to quit drinking.

A 2016 study suggests psilocybin might also help people quit smoking. Researchers recruited 15 volunteers to receive both psilocybin and a cognitive-behavioral therapy-based quit-smoking program.

A year later, 67% had successfully quit smoking, and at 16 months, 16% remained non-smokers. These are significantly higher success rates than doctors typically see either with other medication or with therapy alone.

Ibogaine is another plant compound that early research suggests may prove beneficial in treating extreme addiction. Learn more about it here.

Eating disorders

The mystical and psychedelic experiences a person has with psychedelic therapy may shift their body image away from unhealthy thoughts, potentially easing symptoms of eating disorders.

A 2020 systematic review reports on people who underwent psychedelic therapy for eating disorders, several of whom said their experiences while under the influence of drugs offered them new insights that encouraged them to embrace healthier habits.

People with eating disorders often have other mental health symptoms, so psychedelic therapy might ease the symptoms that lead to disordered eating. A 2020 study of 28 people with a history of eating disorders found that psychedelics significantly reduced participants’ reported depression symptoms.

Risks

Psychedelic drugs induce powerful changes in consciousness that can cause serious side effects. These may includeTrusted Source:

  • Psychosis: This is a break from reality that may be more likely in people with conditions known to cause psychosis.
  • Fear: Some people hallucinate things that terrify them, cause them to believe they are dying, or even that induce trauma and flashbacks.
  • Cardiovascular issues: Psychedelics can elevate the heart rate and blood pressure, so people with a history of heart disease should discuss their history with a provider before trying psychedelics.

It is very important to note, however, that despite these risks, most studies report few or no negative reactions.

Summary

Psychedelic drugs can induce powerful, and nearly immediate, psychological changes. Some research suggests these changes persist over the long term, offering hope to people struggling with serious mental health conditions.

Psychedelics remain an experimental treatment, and not something someone can get as a matter of course in their doctor’s office or in therapy. Moreover, researchers do not fully understand how they work, how to predict who will get the best results, or how to minimize the risk of side effects. For most people, the benefits of psychedelics remain purely theoretical.

As more research emerges, psychedelics could become mainstream and accessible. Until then, people interested in trying this treatment should talk to a provider about joining a clinical trial.

* Last medically reviewed on June 29, 2021

Story from – Medical News Today

Canadian entrepreneur gifts $5 million to help create psychedelic research centre for mental health

CTV Health News – October 24, 2021

TORONTO — Canadian tech entrepreneur and venture capitalist Sanjay Singhal was in his early 30s when he was first diagnosed with bipolar disorder. It had been a lifelong struggle — one moment feeling great, then suddenly mentally paralyzed and unable to get out of bed for three straight days.

“When I went manic, I would make bad decisions … spend money unreasonably,” he said. “Up until age 38, my life was a roller coaster.”

Today, Singhal is 56 and on a mission to transform mental health care. He is the philanthropist behind Canada’s first psychedelic psychotherapy research centre for mental health at Toronto’s University Health Network (UHN). Starting with a $5 million donation made through the Nikean Foundation that he founded, Singhal hopes researchers at the centre can unlock the potential of psychedelic medicine and find answers on how psilocybin and a so-called “God molecule” can help transform mental health care.

“I was very aware of what mental illness can do,” he said in his very first on-air interview about the subject and his personal struggles with it.

But it is not just about him. He also has a daughter, Nikki, who has struggled with anorexia since childhood that he also wants to help. She was hospitalized at the age of eight, and again when she was 16. Now a third year resident in psychiatry at the University of Toronto, she has done well but continues to navigate through her struggles.

A chance presentation several years ago by Robin Carhart-Harris, one of the world’s leading researchers on psychedelic medicine that mentioned psilocybin as a potential treatment for anorexia piqued Singhal’s interest. Carhart-Harris is the head of the Centre for Psychedelic Research, a division of Brain Sciences with the Faculty of Medicine at the Imperial College London.

“I thought, oh my God, I have to go listen to this guy and see what’s going on…I spoke to him afterwards, drove him to the airport, and then a couple of weeks later, my daughter and I both flew to London … we were amazed at the possibilities of what this could do.”

But Singhal is quick to note that at the Canadian research centre, psychedelic medicine will only be used alongside therapy in a controlled setting.

“I don’t want people to do this on their own,” he said. “I don’t want this to become recreational play.”

A POTENTIAL PARADIGM SHIFT

The potential of psychedelic therapy goes as far back as the 1950s when several pioneering psychiatrists experimented with LSD as a possible treatment for mental health disorders. Some of the earliest groundbreaking experiments and research happened in Saskatchewan. But studies into these drugs ended by the 1960s amid social and political backlash.

For scientists, the new research centre represents potential for transformational change in mental health therapies and offers new hope for many patients.

“I was thrilled beyond belief because psychiatry hasn’t had a real paradigm shift or a new opportunity at treatment in a long time,” said Dr. Susan Abbey, psychiatrist-in-Chief for the Centre for Mental Health at UHN, in an interview.

“There truly is a signal that there is something to this. And, really, every major academic center in mental health in the world is trying to begin to conduct research in psychedelic, particularly psychedelic assisted psychotherapy.”

There are many disorders, including post-traumatic stress disorder and end-of-life distress, that are treatment resistant, says Abbey.

Dr. Emma Hapke, a staff psychiatrist with UHN and lecturer at the University of Toronto agrees.

“We haven’t had a lot of new treatments in psychiatry in a long time. There seem to be more people suffering…struggling and there is an appetite for something new that might work,” Hapke told CTV National News in a phone interview.

Traditional medications prescribed for mental health care typically suppress symptoms, Hapke said. While much more research is needed, there are suggestions that psychedelics work differently and do not require ongoing use.

The centre is planning six to eight research projects, including psilocybin therapy for end-of-life grief, grief suffered by caregivers, families who have lost a child, and body dysmorphic disorder.

It also hopes to research a separate psychedelic called 5-MeO-DMT, also called “The God Molecule” due to the profound psychoactive effects on the user, as a potential therapy for PTSD. Found in a wide variety of plants, it is also secreted by the glands of the Sonoran Desert Toad. It is illegal in the United States but unregulated in Canada. BuzzFeed News once described it as “the most powerful psychedelic on the planet.”

The centre is also looking at training programs for licensed therapists to learn how to work with psychedelics, since treatments will likely also involve therapy for patients to understand the insights that emerge with treatment.

TRYING PSILOCYBIN AND THE ‘GOD MOLECULE’

Singhal grew up in a tumultuous household, and from a young age, built emotional walls around himself without even realizing. If he encountered someone who clearly needed emotional comfort, his automatic response was escape.

“I was afraid of other people’s emotions,” Singhal said. After three psilocybin sessions, everything changed.

“Now, my instant thought is, I need to sit down with this person and comfort them, find out what’s going on. That has been tremendously beneficial for my relationships.”

Singhal’s original intent when he decided to try psilocybin as a therapy was to find out why he sometimes drank too much and to get a handle on that aspect of his life. He had already been seeing a therapist for 20 years, and while it has helped him get through some of the most depressed periods of his life, psilocybin was different. Suddenly, he felt liberated, he said.

“The psilocybin took me on this circuitous journey of, no, let’s explore what’s really going on here,” he said.

But Singhal is perhaps even more interested in the potential of 5-MeO-DMT, which is still in the drug development process phase and likely years away from clinical trial use.

One of the challenges with psilocybin and MDMA is that they are expensive treatments, Singhal explained. It takes four to six hours in a room with one or two trained therapists, licensed professionals, so a single treatment can run upwards of $2,000 or more.

5-MeO-DMT lasts just 15 minutes, which makes potential treatment significantly more affordable, he said.

”You’re not aware you’re conscious, but you’re not aware of what’s going on so when you come back from that trip, all you know is something beautiful happens. And all of a sudden you feel better,” Singhal said.

While much of the new research involving these psychedelics are still considered very early stage, Singhal’s experience and newfound peace gives him hope.

“The apparent lack of adverse effects is reassuring and consistent with what we know about these compounds more generally – that when administered in a responsible manner, to suitable and prepared individuals, they are almost invariably well-tolerated,” according to a research commentary on 5-MeO-DMT published in 2019 in The American Journal of Drug and Alcohol Abuse.

But it also added that “any conclusions pertaining to the antidepressant efficacy of 5-MeO-DMT must wait until the appropriate clinical trials are conducted.”

UHN doctors agree all the compounds need rigorous scientific study.

“We need to take a very careful approach… so that we don’t just get so swept away with potential excitement, but that we’re really understanding how medications work what they do for people,” said Abbey.

Singhal acknowledges that much of the evidence that psychedelics could be used to help with anorexia or other mental disorders is anecdotal, but it is enough that he is willing to write a big check to fund the research necessary.

“We’re all traumatized children running around in adult bodies, and these medicines can help us all,” Singhal said.

“I would say, now, three years later, my daughter has tried various treatments, and she’s still struggling, but she has hope. And if … this gives somebody hope, that’s a tremendous gift.”

Correction:

In the second last paragraph under “A potential paradigm shift” subhead, the legal status of 5-MeO-DMT was corrected to unregulated and a reference to Health Canada exemptions was removed, as it was in reference to a different type of DMT.

Story from CTV Health News


Can Psychedelic Drugs Treat Physical Pain?

LSD and psilocybin increasingly show promise as mental health treatments. Now universities and companies are exploring their use in pain management

By Troy Farah on September 30, 2021

When Kevin was just 11 months old, he was diagnosed with type 1 diabetes, which led to other health problems as he grew up: loss of vision in his left eye and peripheral neuropathy, a painful condition caused by nerve damage. Then, in 2019, a colonoscopy revealed he had colon cancer.

Feeling anxious and depressed, Kevin (a pseudonym) decided to try self-medicating with psychedelics, including psilocybin-containing “magic mushrooms.” Twice a week, the now 28-year-old delivery driver takes about half a gram of the outlawed fungi. This amounts to too little psilocybin to induce a full-blown trip, and Kevin says he quickly noticed an improvement in his mental health—a result that is in line with a handful of recent studies about the drug’s clinical potential. And he was pleasantly surprised to find that his physical pain seemed to decrease as well, even on the days he was not taking anything.

“A lot of the anxiety and depression I was dealing with started to fade away—and then the pain in my legs started to go away,” Kevin says. “I’m feeling the lasting effects from the psilocybin on my stomach and colon pretty much all the time.”

Vivid colors, warped textures and sounds, and intense introspection are famously associated with the psychedelic experience—and now, increasingly, so are improvements in mental health conditions such as anxiety and post-traumatic stress disorder. But what about pain relief? That is the question a growing number of researchers are asking, based on anecdotal reports that drugs such as LSD or psilocybin can help with this. Both drugs are currently illegal under federal law, though medical studies on them are now being officially cleared with increasing frequency.

From psychedelic start-ups to university labs, scientists are starting to test such drugs on various types of pain: cluster headaches, chronic pain, fibromyalgia and even phantom limb pain. This May a New York City–based, multimillion-dollar psychedelic start-up called Mind Medicine (MindMed) announced Project Angie—a series of studies using LSD and an undisclosed drug to treat chronic pain.

“We don’t really know how psychedelics work to modulate people’s long-term symptoms in any illness, let alone pain disorders, which are less studied than some of the others,” says physician Dan Karlin, MindMed’s chief medical officer. “But there is compelling preclinical evidence that they work … via psychological mechanisms … but also may have some direct effects on descending pain pathways.”

Tryp Therapeutics, a California-based psychedelic start-up, is exploring chronic pain relief using psilocybin and another, psilocybin-based drug with an undisclosed formulation that is obliquely called TRP-8803. The company has also partnered with the University of Michigan to study how these drugs might treat fibromyalgia, a complex and little understood condition blamed for pain throughout the body. Tryp has added leading psychedelic researcher Robin Carhart-Harris to its scientific advisory board, and the company says he will play a “critical role” in clinical trial design.

Earlier this year Yale University announced a trial using psilocybin for cluster headaches. And in August the Oxford, England–based pharmaceutical start-up Beckley Psytech raised $80 million for psychedelic research. Part of this will fund a phase 1b safety trial investigating low-dose psilocybin to treat a rare kind of headache called a short-lasting unilateral neuralgiform headache attack.

These efforts are in very early stages, and so far any results are far from clear. Some experts argue that the evidence for psychedelics relieving pain is weak and that these drugs are so powerful that they should only be used in psychotherapy—if anywhere. Even if psychedelics can relieve physical pain, they may not be better tools than those that are already widely available.

“Pain is this four-letter word that can mean so many different things,” says Vivianne Tawfik, an assistant professor of anesthesiology, perioperative and pain medicine at the Stanford University School of Medicine. At an outpatient clinic, Tawfik treats rare and refractory types of pain usually associated with surgery or injury, such as chronic neuropathic pain and complex regional pain syndrome. “There’s a role for opioids,” she says. “There might end up being a prescribed role for psychedelics. The jury’s still out.”

Tawfik warns that any off-target effects of psychedelics need to be carefully monitored. “I think abuse liability needs to be really closely considered, making sure that there aren’t unexpected psychiatric effects, certainly in populations at risk,” she says.

HISTORY OF PAIN AND PSYCHEDELICS

One of the earliest recorded studies of pain relief from psychedelics was conducted by Eric Kast, an Austrian-born physician who fled the Nazis with his family in 1938 and resettled in the U.S., later becoming an anesthesiologist at Chicago’s Cook County Hospital. Kast had an early interest in how to measure pain responses: in 1962 he designed an elaborate apparatus—a pneumatically operated “mechanical pain-producing device”—that used air pressure to let a subject apply a “pain-producing element” (possibly a needle) to their own leg.

Two years later his attention was drawn to the powerful psychedelic LSD, which he tried giving to 50 “gravely ill” patients afflicted by pain with causes ranging from cancer to gangrene. They first received the synthetic opioids hydromorphone (Dilaudid) and meperidine (Demerol)—and later they were given 100 micrograms of LSD as well. This would be a strongly psychoactive dose for most people.

“When compared with LSD-25, both [other] drugs fell short in their analgesic action,” Kast wrote in 1964. It was a remarkable anecdote but barely investigated further. For decades this remained some of the best research in this area, aside from a few case studies.

“I feel like most of the studies that were done weren’t done well,” says Fadel Zeidan, a neuroscientist who studies the underlying mechanisms of pain and mindfulness at the University of California, San Diego. Zeidan, who is co-leading a study on psilocybin for phantom limb pain, would like to see “higher standards, more rigor” in this area of research. In 2020 he co-authored a review that weighed the evidence of psychedelics relieving chronic pain and proposed a mechanism of action. The review noted that psychedelics act on the body’s serotonin receptors—notably the type known as 5-HT2A—which have been linked in some research to the development of chronic pain.

“Serotonin is also involved in descending modulation of pain [from the brain] down to the spinal cord,” Tawfik says. But she and others note there are currently very little data to back up the hypothesis that psychedelic pain relief acts through this mechanism. “Even though we know that some of the receptor systems that underlie pain are probably similar, there’s probably a lot of nuance that we don’t really know yet or appreciate.”

One of the few double-blind, randomized, placebo-controlled studies on this topic was published last year. Researchers at the Netherlands’ Maastricht University and their colleagues trialed 24 people who were given an oral solution of ethanol containing either a low dose of LSD (too low to cause strong effects such as visual disruptions) or a placebo. Then the subjects placed their hands in almost freezing water. The longer they could keep their hands submerged, the better their pain tolerance was determined to be.

Ratings of pain tolerance from subjects who received LSD were comparable to those in studies with the opioids oxycodone and morphine, leading the authors to conclude in the Journal of Psychopharmacology that “low doses of LSD might constitute a novel pharmacological therapy.”

Again, the researchers hypothesized that serotonin receptors had a role in this effect. Two of the scientists who conducted this study, Matthias Liechti of the University of Basel and Kim Kuypers of Maastricht University, are currently working with MindMed on its LSD and pain research. And the paper’s lead author, Johannes Ramaekers of Maastricht University, says he is developing another pain study to look at psychedelics and fibromyalgia.

But Boris Heifets, a Stanford Medicine anesthesiologist who studies pain—as well as “rapid acting psychiatric therapies,” including psychedelics—says the focus on serotonin in pain relief is probably a “red herring.” Heifets (who is beginning a trial looking at psilocybin and chronic lower back pain) argues that the fact that psychedelics can also improve mood should not be overlooked, given neurological connections between pain and depression.

“If these drugs are going to help, it’s going to be much like the way we think they help for depression—[that is], changing your relationship to your pain,” Heifets says, emphasizing that psychotherapy is the core of psychedelics’ apparent effectiveness in mental health. “The revolution with this class of medicines is that it’s really not just medication alone…. This whole body of research is emphasizing the importance of therapy, psychological support and connection.”

U.C. San Diego’s Zeidan agrees. What a drug like psilocybin could be doing is helping “treat the whole person,” he says—adding that he believes this should be a greater focus of modern medicine in general.

“Chronic pain is really just this comorbid snowball of shit,” Zeidan says. “It’s not only the sensory abnormalities, but it’s also the depression, the anxiety, the sedentary lifestyle, the self-doubt, learned helplessness—it’s this whole thing.”

If psychedelics are ever prescribed for pain, it would not be the first time a drug developed for another kind of treatment has been co-opted in this way. Gabapentin and pregabalin (Lyrica) are two antiseizure drugs now commonly prescribed for nerve pain, while duloxetine (Cymbalta) is an antidepressant often used to address chronic musculoskeletal pain.

Despite the scarcity of solid evidence that psychedelics can tackle physical pain, some people like Kevin are not waiting. Three others interviewed for this article claim to use LSD to treat different types of pain, from cluster headaches to degenerative disc disease in the neck and lower back.

All say they are willing to risk breaking the law because they have tried everything else, with very little success. The steadily increasing research could shed some light on whether these long-demonized drugs can relieve physical suffering—or if they are simply placebos—while also examining long-term side effects.

“Every individual’s experience of chronic pain is unique,” Tawfik says. “Many of my patients are still looking for better treatment options…. We just always need to have these risk-benefit conversations with any of these medications.”

Story from Scientific American


US Government issues first grant for psychedelic research in over 50 years

Kevin Dinneen – September 29, 2021

Matthew W Johnson, a professor at John Hopkins University and an expert in psychedelics, drugs and addiction announced last week that he is the first researcher to be given federal funding for over half a century to directly study therapeutics of a classic psychedelic.

Announcing the grant on Twitter, he said “It’s official. I just received a U01 grant from NIDA to study psilocybin for tobacco addiction. To my knowledge it’s the 1st grant from the US government in over a half century to directly study therapeutics of a classic psychedelic. Hopefully this starts a new era in legitimacy of psychedelic science. Hopkins will lead a multi-site trial with the other two sites being University of Alabama at Birmingham (site leader Peter Hendricks) and New York University (site leader Michael Bogenschutz). Big thanks to all the colleagues at Hopkins and the other sites, especially Albert Garcia who has been the lead co-investigator and primary session guide on the smoking research for the last decade.”

Matthew is the principal investigator in the psilocybin-facilitated smoking cessation study, and also claims to be the holder of the, “first endowed professorship on the planet with psychedelics in the title’. He told The Truffle Report “I’m extremely excited about it. The government funding for a therapeutic trial of psychedelics is something the field has been waiting on for 20 years now in the modern renaissance of psychedelic research”.

The study will be one of the first studies into the therapeutic qualities of psychedelic mushrooms since the war on drugs was declared in the 1970s. The Swiss scientist Albert Hoffman, famous for being the first person to synthesise LSD, was also the first person to synthesise and name the principal psychedelic mushroom compounds psilocybin and psicolin.

The federal U01 grant, known as a ‘Research Project Cooperative Agreement’, is to fund the multi-centre high-risk clinical study into using psilocybin to help smokers quit the habit. It is being conducted by John Hopkins University, New York University, and the University of Alabama at Birmingham, USA. Global tobacco-related deaths stand at approximately 6 million per year, and that number is projected to rise to around 8 million deaths annually by 2030. Smoking is still considered to be a big public-health concern worldwide.

“This is extremely encouraging. Public funding for psychedelic science is critical” says Doctor Hendricks, professor at the Department of Health Behavior of the University of Alabama at Birmingham. “My hope is that this opens the door to further scientific inquiry, and ultimately, the advancement of a treatment paradigm that has the potential to alleviate suffering across the globe”.

Story from Leafie UK


This is why psychedelics improve your relationship

Written by Erik McLaren – December 08, 2017

According to several studies Magic mushrooms, LSD, MDMA and other psychedelics improve relationships by inspiring empathy, communication, and self-awareness.

For the first time, psychedelics are truly being studied as medicine and not a menace. The promise of psychedelics as a treatment for PTSD seems to have no ceiling, but other findings have shown that psychedelics improve relationships. Finding a partner is one of life’s most worthwhile challenges. Magic mushrooms and MDMA and LSD might be catalysts to a deeper connection according to scientific studies.

By helping people understand the impact of their actions

In 2016, the University of British Columbia followed more than 300 men with substance abuse issues after their release from prison. Some of these men decided to take psychedelic drugs after their release, and some did not. Twenty-seven percent of The group that took psychedelics were arrested on domestic violence charges within six years. That number jumps to 47 percent for men who didn’t take any psychedelics.

This was not a clinical trial, but an observational study. The study didn’t instruct these men on dosage, or even what psychedelic drug they should take. Chance alone doesn’t explain the difference between these two groups.

Avoiding domestic violence isn’t a high bar for a partner, however, it is a shockingly common problem. One author of the study told Science Daily, “this study, in stark contrast to prevailing attitudes that view these drugs as harmful, speaks to the public health potential of psychedelic medicine.”

But this isn’t the only study in recent years to run contrary to current attitudes on psychedelics.

By inspiring meaningful conversations

When it comes to romance, finding a partner is often portrayed as the finish line. That can’t be further from the truth. Relationships require constant upkeep and discussion with mutual respect and understanding. MDMA may be able to help inspire those kinds of conversations.

The Multidisciplinary Association for Psychedelic Studies (MAPS) is currently running the third phase of their federally approved MDMA study to treat PTSD. In 2016, MAPS also sponsored a study that looked at couples therapy with MDMA, where one partner suffered from PTSD. That study is still ongoing, but plenty of anecdotal evidence suggests that it will yield positive results. A similar study in the UK also found MDMA can help couples communicate.  What may also be surprising to some is the fact that the United States only banned MDMA in 1985 and that before that, therapists often used MDMA in couples therapy.

Many couples are turning to magic mushrooms to help keep their relationships in perspective. One study concerning the affect of mushrooms on depression, also found that the shrooms improved participants’ relationships overall. LSD is becoming another tool in improving relationships. Due to the large volume of anecdotal evidence, further research is necessary.

Psychedelics improve relationships by increasing empathy and self-awareness.

Isaac Pivovaroff, a former seal in the Navy who fought in Afghanistan and Iraq undergoes treatment for PTSD and drug addiction at the ” Better Tomorrow” treatment center in Murrieta, California. (Photo by Charles Ommanney/Getty Images)

Like the early days of medical marijuana studies, the results from almost every study of psychedelic medicines have positive results. Whether it’s helping people cope with death, or alleviating soldiers PTSD, psychedelics have powerful effects on the brain.

Study after study shows that experiences people have psychedelics are routinely the most powerful and meaningful in the participant’s lives. The power in those experiences comes from psychedelics ability to help people through addictions, to generally increasing mindfulness. Some studies show that psychedelics can positively influence someone’s personality, for years to come.

Psychedelics have been linked to increased empathy, and create a situation where the deep and complicated interconnectivity of life seems clear and tactile. This not only makes people better partners, it can make them better people.

 Article from – Herb