Summary: GQ Australia provides a glimpse into how the growing acceptance of psychedelic therapy is influenced by positive results from clinical trials. The article illustrates the influence that psychedelics may have in psychiatry if legalized, pointing to MAPS-sponsored clinical trials of MDMA-assisted psychotherapy as a treatment for PTSD. Brad Burge, MAPS Director of Strategic Communications, explains, “Unlike all other medications for PTSD, with MDMA-assisted psychotherapy, patients only take the drug two or three times over a 10-week course of psychotherapy – and research suggests that the benefits last.”
Originally appearing here.
We’ve heard it over and over again: drugs are bad. But a group of medical researchers are challenging the stigma around mind-altering substances – and discovering they could hold the key to tackling a whole range of mental health issues.
At any given time, there’s a mere handful of people truly tapped into the zeitgeist. In music right now it’s Kendrick Lamar; in fashion Virgil Abloh; in film it’s Dwayne Johnson.
You can add author Michael Pollan to the list. His 2006 book The Omnivore’s Dilemma was part of a seismic shift in which readers and eaters began questioning where their food came from, how it was produced and who was fucked over along the way (the farmers, the animals, the planet) in order to get it to your plate.
By the time the 10th anniversary edition was released, it had sold more than two million copies. But this year, he shifted his focus from the stomach to brain with How to Change Your Mind – The New Science of Psychedelics and cemented his rep as a writer at the very edge of public consciousness.
The starting point was the concept of microdosing – a red-hot trend in Silicon Valley and beyond – where the most lateral of thinkers are taking small amounts of LSD, which generate ‘subperceptual’ effects that can improve mood, productivity and creativity.
A smart drug for smart people, if you believe the hype.
Pollan characteristically built on this by replacing the microdosing with macrodosing. By which we mean he took drugs. Many, many drugs. In quantities that make people, according to the New York Times, “feel the colours and smell the sounds”.
Whether or not he knew it at the time, he ever so slightly wedged open the doors of perception when it comes to psychedelic drugs and their potential benefits. In so doing, he has tapped into a burgeoning movement in which, primarily, ‘recreational’ drugs, such as LSD, mushrooms, marijuana, ketamine and MDMA, are showing glimpses of clinical promise where conventional medications are not.
It’s in the field of mental health that the results are most apparent. Which is just as well because for all the increasing openness we have about discussing this scourge, the numbers are not decreasing. Quite the opposite.
In April this year, mental-health technology group Medibio polled 3500 Australian workers from 41 organisations across a range of industries and found that 36 per cent had depression and 33 per cent had anxiety. In contrast, the 2007 stats list anxiety at 14 per cent and depression at six per cent.
A part of this leap is undoubtedly down to the fact that people are more comfortable discussing these issues and seeking help. That’s a very good thing. However, it’s equally clear that the current approach of counselling combined with the most common medications – selective serotonin reuptake inhibitors (SSRIs) like Lexapro – doesn’t work for everybody.
Nothing does and nothing ever will, but in labs around the world, the go-to party drugs for everyone from bush-doofers to EDM aficionados are throwing up results that are beginning to overshadow their tarnished reputations.
One of these is MDMA, which was invented in 1912 by a German pharmaceutical company to help medications that control bleeding. It first entered the dance party scene in the mid-’80s and quickly became as much a part of these events as tolerating Armand Van Helden, gurning wildly and finding conversations with complete strangers to be fascinating
Manufactured under dubious circumstances at best, there are clearly risks involved with recreational use. But transfer the setting from club to clinic and a different picture emerges. Especially as a potential treatment for people with post-traumatic stress disorder (PTSD). In a study conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS) in the United States, 56 per cent of 107 subjects no longer qualified for PTSD after treatment with MDMA-assisted psychotherapy, measured two months following treatment.
At the 12-month follow up, 68 per cent no longer had PTSD.
“Most subjects received just two to three sessions of MDMA-assisted psychotherapy. All participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years,” says MAPS director of strategic communications Brad Burge.
A separate study conducted this year by the Medical University of South Carolina on an admittedly small group of 26 first responders and military personnel concluded, “Active doses (75mg and 125mg) of MDMA with adjunctive psychotherapy in a controlled setting were effective and well-tolerated in reducing PTSD symptoms.”
There’s a bit to unpack in these qualified conclusions, most notably the terms “with adjunctive psychotherapy” and “controlled setting”. “It’s important to keep in mind that MDMA will not be a take-home drug,” says Burge. “MDMA-assisted psychotherapy is a supervised treatment – it happens in a clinic or therapist’s office, with a medical review and therapeutic supervision. This is not ‘take two and call me in the morning’. Patients would never get a prescription for MDMA to fill themselves at the local pharmacy. Unlike all other medications for PTSD, with MDMA-assisted psychotherapy, patients only take the drug two or three times over a 10-week course of psychotherapy – and research suggests that the benefits last.”
He adds that though the drug has side effects such as possible anxiety, lack of appetite, increased body temperature and nausea for the four to six hours it’s in your system, Burge says, “They are not as extreme or long-lasting as SSRIs” which millions of Australians take daily. “Also, nobody in the completed trials reported dependence or continued use of MDMA after participation in the trial.”
MDMA’s benefits are, according to Burge, not restricted to the treatment of PTSD. “It has also shown promise in early research as an adjunct for psychotherapy for anxiety associated with life-threatening illnes and social anxiety in autistic adults. It is now [also] being studied in alcoholism treatment as well as cognitive-behavioural conjoint therapy (aka couples therapy).”
At the very least, he expects it to be approved by the US Food and Drug Administration for PTSD therapy by 2021.
Closer to home, Dr Gillinder Bedi, a senior research fellow at both The University of Melbourne and Orygen, The National Centre of Excellence in Youth Mental Health, advocates a cautious approach in the MDMA-as-therapy debate.
“The slow progression of MDMA-assisted psychotherapy from the subcultural margins towards approval has been driven by the belief of those advocating for it,” she says. “Without this motivated community, MDMA would likely not have been developed as a medication. The downside of this robust advocacy base is that it can lead to rather extreme claims, such as being labelled ‘penicillin for the soul’. In addition to well-designed studies that control for experimenter bias, there is a need for researchers and clinic
ians outside the MDMA-advocacy community to be involved in the ongoing development of this research direction.”
Clearly there are more questions than answers right now, many of them practical. “For instance, should prescribing be limited to physicians with specific qualifications?” asks Bedi. “What training should be required for those conducting the psychotherapy? How should the drug be handled and stored by pharmacists? This suggests a need for stringent training and oversight of MDMA-assisted therapy.”
Then, there’s the proven human factor where not everyone will play by the narcotic rules. Case in point: Modafinil.
A report by the University of Melbourne’s Brain, Mind and Markets Laboratory found that the anti-narcolepsy drug was the go-to helper for certain finance professionals and students who want to maintain their focus during long hours in the library or plundering the markets. Some is sourced online. Some comes from Australian doctors in a trend known as off-label prescribing. And if Modafinil – known as ‘Viagra for the mind’ – is in demand, wait until your local GP has pure Molly at his or her disposal.
“Approval of MDMA will lead to off-label prescribing, with doctors prescribing the drug for conditions other than PTSD,” says Bedi. “This could include a range of conditions, such as depression and substance-use disorders.”
This is just one of myriad red flags. Burge says MDMA’s therapeutic acceptance has been hamstrung by several additional factors. “Recreational use and abuse has been one source of the stigma, but an even greater cause of the stigma has been the misinformation, bad science, and political posturing that policymakers have engaged in for decades,” she says.
In political terms, the issue of psychedelics as therapy is an easy knee-jerk for neo-cons.
‘This government is spending your tax money on street drugs’ is a convenient and divisive headline, sure to prompt enough harrumphs across the media landscape. There have also been enough tragic high-profile cases, such as that of Sydneysiders Anna Wood and Sylvia Choi – both of whom died after taking ecstasy at dance parties – to place the discussion forever on the back burner. Strike one.
In response, researchers likes Burge are quick to point out that there is a monumental difference in the purity and dosage of the MDMA being sold on the street (and cut with any number of harmful fillers) compared with that used in clinical studies. Then, there’s the financial factor. Specifically, the issue of patents, which tend to run to 20 years in the pharmaceutical industry.
The theory goes that this amount of time generally allows the manufacturer of the drug to recoup their R&D costs and accrue a reasonable profit before generic, lower-cost varieties are made available to the public. The problem, as far as big pharma is concerned, is that the patent on MDMA ran out some time before World War II. Which means that any significant potential turnover arising from exclusivity is immediately off the table. Strike two.
What’s more, unlike your standard SSRI anti-depressants, which require ongoing use (and is therefore more profitable), many of these patent-free psychedelics need only a handful of doses to provide relief. With both potential volume and profit thus diminished, Burge says you have distinct “lack of interest” on the part of for-profit pharmaceutical companies. Strike three. Attitudes are slowly changing in the pharmaceutical community and Burge is confident that “within the next 10 years, we’ll see psychedelics enter psychiatry as the first new class of psychiatric drug in the last 30 years”.
However, it’s unlikely that many Australians will be able to access legal therapeutic MDMA any time soon. Considering how long it took to convince them of the medicinal benefits of marijuana, no local politicians are waving the psychedelic flag just yet. Those who might benefit right now have to be lucky enough to qualify for one of the few small local clinical trials.
In this respect, organisations the Sydney’s Black Dog Institute are creating some world-firsts but these options are still few and far between. Writing in April’s Australian Psychologist journal, doctors Stephen Bright and Martin Williams warned that Australia was being left behind the rest of the world on the research front. Bright noted that there is “a lot of academic conservatism” in Australia towards research involving drugs which are best known as illegal stimulants, adding that there was “a vested interest in maintaining the current paradigm”.
And it’s not just MDMA in the firing line. Everyone’s favourite horse tranquiliser, ketamine, is also prompting words like “astounding” from medical researchers not given to hyperbole. In 2016, the University of New South Wales’ Professor Colleen Loo began a randomised double-blind three-year trial into the effectiveness of the drug as a depression treatment for people who have not responded to other medications.
The 16 subjects were all over 60 and Loo found that half showed no signs of depression after a single dose. “I was a bit sceptical with all the reports coming out from overseas,” Loo told Triple J, “I thought, ‘I’m just not sure if I believe this, it’s unbelievable’. And I must say, the first person we treated – I still remember the very first person – he and I looked at each other and he said, ‘I don’t believe it’, and I said, ‘Neither do I’. He’d been depressed for literally 10 years and had failed more than 10 medications. He said, ‘The fact I can receive one treatment and be well after one day is just unbelievable’.”
In an approach guaranteed to alarm psychedelic proponents and provide ammunition to critics, he bought some ketamine off the dark web and began experimenting. Successfully, it turned out. “My life outlook is much more positive now,” he said. “It’s allowed me to take back my life in a sense. From years of having to put life on hold, I found that it was a lot more worthwhile and cost-effective than spending my life on antidepressants.”
Much like MDMA, the popularity of ketamine on the black market makes it vulnerable to exploitation and misuse – which is why almost every researcher GQ interviewed spent a great deal of the conversation issuing caveats.
Yet, away from the world of dance parties and K-holes, it has the potential to save lives in the most immediate and drastic sense of the term. In the first study into esketamine (a part of the ketamine molecule) conducted by a drug company (in this case Johnson & Johnson) with Yale University, 68 people at risk of imminent suicide were treated with the drug. The authors found it not only led to a “significant” improvement in depressive symptoms within 24 hours but also levelled off at around 25 days – which is roughly the time it takes for antidepressants to kick in to full capacity in the body.
Commenting on the data, England’s often-conservative Royal College of Psychiatrists said that it brought the drug “a step closer to being prescribed on the NHS”. Because Australian doctors have access to ketamine as an anaesthetic and pain reliever, authorities fear it too may be prescribed ‘off label’ without enough research into the long-term consequences (if any) of its use in suicide prevention.
Israeli-American writer Ilana Masad was given ketamine by her psychiatrist in an attempt to counter her stubborn depression. Writing for The Fix, an online publication devoted to addiction and recovery, she revealed, “Shortly before my first ketamine treatment, I became suicidal for the first time in my life. If I hadn’t started ketamine treatments when I did, I don’t know whether I’d be here writing this article now.”
While the likes of MDMA and ketamine made their way into public consciousness from the ’80s onwards, those wanting to take a trip in the psychedelic ’60s turne
d to LSD.
‘Acid’ is also experiencing its own contemporary resurgence and according to an analysis published in the Canadian Medical Association Journal, there are studies being done on the use of lysergic acid diethylamide as a treatment for post-traumatic stress disorder and anxiety.
A more natural alternative may be found in psilocybin – the active hallucinogen in magic mushrooms. Johns Hopkins University researchers gave the drug to 51 cancer patients also suffering from mental-health issues like anxiety or depression. Six months on, it was found that about 80 per cent of participants continued to show clinically significant decreases in depressed mood and anxiety, with about 60 per cent showing symptom remission into the normal range.
Researchers stressed that the drug was given in tightly controlled conditions in the presence of two clinically trained monitors and said they do not recommend use of the compound outside of such a research or patient-care setting. But what’s most astounding about this was that the results were again achieved in a single dose.
Another natural compound, ibogaine, is also gaining clinical attention. A psychoactive found in plants from the Apocynaceae family, it’s being examined as a potential therapy for those battling drug dependence.
Make no mistake; this is dangerous gear with severe side-effects including hallucinations, seizures, fatal heart arrhythmia and brain damage in patients with prior health problems. In 2014, 33-year-old West Australian Brodie Smith died on the first morning of what was supposed to be a four-day ibogaine treatment program in Thailand. He was trying to kick his dependence on illegal drugs. And yet, there are several studies that suggest that ibogaine, under appropriate conditions, could well be a habit-breaker.
As reported in Scientific American, in May 2016 a meta-analysis examining 32 studies, mostly in mice and rats, found that ibogaine reduced self-administration of cocaine, opioids and alcohol.
An earlier study from 2015 discovered noribogaine, the substance that ibogaine breaks down to when ingested, reduced self-administration of nicotine in addicted rats by 64 per cent.
Californian company Savant HWP has now progressed to secondary trials for a synthetic ibogaine compound, called 18-MC, which mimics the anti-addiction properties without the trippy side-effects. The potential benefits for Australia are obvious as opioid prescriptions here increased from 10 million per year in 2009 to 14 million per year at the end of 2017 – that is an increase of 40 per cent over the past eight years. Worth a look, then.
With new applications and (again) appropriate safeguards for once demonised substances, be they chemical or naturally occurring, in place, Burge believes we are on the threshold of a giant leap forward in the way we treat our troubled minds and bodies.
If Australia’s growing acceptance of marijuana as a legitimate treatment in palliative care, epilepsy, chronic pain and multiple sclerosis is anything to go by, it’s clear that we are no longer as attached to the notion that because a drug can be misused it should automatically be sidelined and vilified.
“The resistance to this notion is definitely fading,” says Burge, “and it fades more with every new study that’s completed. Researchers from multiple organisations and institutions around the world are showing real therapeutic benefits from psychedelic-assisted therapy, especially MDMA and psilocybin and also ibogaine, for specific mental-health conditions. That data, and the overall very supportive attitude of policymakers and regulators around the world, are resulting in what’s been called a renaissance in psychedelic research.”
Unsurprisingly, it’s Pollan who best articulates the here and now.
“What excites me is the potential of these medicines to help people for whom we don’t have a lot to offer. Mental-health care worldwide has not been that effective. We still deal with very high rates of mental illness, and that’s all getting worse,” he says. “So the idea that we might have a tool that could help with a whole range of different problems – from addiction and depression to obsession and anxiety – that’s very exciting.”
They will not offer a silver bullet in the fight against mental-health issues – nothing ever has. But by reducing the stigma around psychedelics, there is now increasing evidence that these treatments may offer new hope to those at the very precipice of despair. Seems it might be time to open our minds.