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Is MDMA about to become medicine?

In 2021, a clinical trial uncovered the impressive efficacy of the club drug in treating post-traumatic stress disorder. Three years later, and the F.D.A. is scheduled to make an announcement on whether it’s ready to move forward with approving Ecstasy for therapeutic use.

In what’s poised to be a watershed moment in the nascent field of psychedelic medicine, MDMA-assisted therapy is facing an imminent F.D.A. decision.

A decades-long campaign to legalise the club drug as a mainstream medical treatment will reach a climax this week, with the federal agency on the brink of deciding whether Ecstasy – as it’s more commonly referred to – should be approved for therapeutic use in the US.

Since it emerged as a novel psychotherapeutic tool in the 1970s and early 80s, scientists and researchers have sought to prove the extraordinary potential of this substance to treat PTSD.

MDMA is a synthetic drug that can act as a stimulant and mild hallucinogen, but is primarily considered an ‘empathogen’ as it can amplify emotional connection and feelings of empathy.

Time and time again, it’s shown genuine promise in alleviating the state of heightened anxiety and corresponding flashbacks, nightmares, and fear responses that those suffering from one of the most intractable mental illnesses must endure for their entire lives.

With stigma still firmly attached, however, attempts to rebrand and integrate Ecstasy into current healthcare systems have been relatively futile.

Until 2021, that is, when a breakthrough clinical trial provided the team at the Multidisciplinary Association of Psychedelic Studies (MAPS) with new data to back their claims.

According to their study, which was published in Nature Medicine, of the 90 combat veterans, first responders, victims of sexual assault, mass shootings, domestic violence or childhood trauma involved, those who received MDMA during talk therapy experienced a significantly greater reduction in the severity of their symptoms compared with those taking an inactive placebo.

After 18 weeks and three sessions, 67% of participants in the MDMA group underwent a transformation so notable they no longer met the threshold for a PTSD diagnosis.

Not only this, but the drug produced no serious adverse side effects besides temporary nausea and a mild loss of appetite.

‘This is about as excited as I can get about a clinical trial,’ Albert Garcia-Romeu, a neuroscientist at Johns Hopkins University School of Medicine, told The New York Times in 2021.

‘There is nothing like these results for a neuropsychiatric disease. This is a wonderful time for discovery, because people are suddenly willing to consider these substances as therapeutics again, which hasn’t happened in 50 years.’

As MAPS outlines in the findings, combining Ecstasy with therapy allows the brain to repair itself by processing painful memories rather than masking them – as is the case with traditional pharmaceuticals.

In other words, MDMA-assisted therapy stimulates one’s own conscious ability for self-healing and helps people with PTSD transition from a hypervigilant, hyper-aroused state into a mindset where processing trauma becomes more feasible.

As a result of this, adding the drug (which affects a wide range of neurotransmitters facilitating signalling between neurons including serotonin and dopamine) to the equation aids people in overcoming a disorder faster.

Able to reopen what’s referred to as a ‘critical period,’ which is the window during childhood when the brain has the superior ability to make new memories and store them, it brings about progress that otherwise takes years to achieve.

The non-profit organisation stresses, of course, that MDMA taken in isolation, without therapy, does not automatically have benefits – it’s the enhancement of the process alongside a willingness to engage with trauma that works.

‘The findings make a clear case for medical approval,’ said Garcia-Romeu. ‘It represents a sea change that could revolutionize health care.’

Three years later, and this sea change may soon become a reality.

This is because the F.D.A., despite having raised red flags about trial methodology, bias, and potential data suppression and initially rejecting MDMA-assisted therapy for these reasons, is scheduled to make an announcement about moving forward with the treatment.

The regulators have until Sunday to decide if they will sign off on legalisation, after an unabating push from proponents – specifically veterans, who are some of the most visible advocates, arguing it fills a much-needed gap in effective treatments for PTSD – and more than 60 bipartisan lawmakers in the House and Senate to do so.

Consequently, most in the field believe that approval is not so much a matter or if, but when.

‘Even if there are risks, we’ve got to figure this out, because we cannot not let this treatment be available,’ Rachel Yehuda, a professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai, tells the BBC.

‘Without it, we’re just leaving too many people in suffering that they don’t need to be in, and that is not right.’

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