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FDA approves large-scale clinical trials of ecstasy to treat patients with PTSD

  • US scientists will treat 230 patients with the rave drug ecstasy aka MDMA 
  • MDMA is classed Class A (Schedule 1 in the US) alongside heroin and LSD 
  • It is known for giving clubbers a psychotic feeling of happiness 
  • But researchers claim it could help ease symptoms of autism or PTSD

The FDA has approved large-scale clinical trials of ecstasy to treat patients with post-traumatic stress disorder.

The phase three trial, funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), will involved 230 patients or more.

It is the sixth MAPS-funded study of the rave drug as it rapidly gains widespread support as a potential treatment for psychological disorders and autism.

A previous study cleared 66 percent of participants of PTSD, while another reduced symptoms in 56 percent of patients.

If the trial is successful, ecstasy – also known as MDMA, Molly, and (officially) methylenedioxymethamphetamine – could be publicly available for medical use in 2021.

It is hardly the first attempt to bring MDMA into the lab.

Early clinical cases and a small trial in 2013 also showed some use for MDMA as a treatment during therapy for patients with PTSD, possibly aiding patients in forming a stronger bond with a therapist.

Many researchers have argued the legalization of medical marijuana in many states across America should open the door to the possibility of testing other banned substances.

Unlike cannabis, however, MDMA’s effects are not physical.

Medical marijuana activates cannabinoids – a series of nerve endings in the body – to treat back pain, anxiety and depression.

While autism has physical causes, the use of MDMA would be purely psychological, to inspire empathy.

The drug induces a chemical high that makes abusers feel extremely happy and empathetic.

It has been banned since 1986, ranked as dangerous as LSD and heroin.

Despite the dangers, there are growing calls in the neuroscience and psychiatry communities for clinical trials to test the medical benefits of MDMA.

Earlier this year, researchers at Stanford University published a paper concluding the substance could give autistic people a powerful psychological experience that could help them connect better with their therapist.

In July the Stanford team penned an open letter in the journal Cell, urging regulators to lift the tight restrictions to let them test humans.

‘We’ve learned a lot about the nervous system from understanding how drugs work in the brain – both therapeutic and illicit drugs,’ Robert Malenka, a psychiatrist and neuroscientist at Stanford University, wrote.

‘If we start understanding MDMA’s molecular targets better, and the biotech and pharmaceutical industries pay attention, it may lead to the development of drugs that maintain the potential therapeutic effects for disorders like autism or PTSD but have less abuse liability.’

More than 200,000 people a year are diagnosed with autism in the US.

It is a chronic condition that impacts the nervous system, making communication, social interaction and empathy difficult.

MDMA is described as an ’empathogen,’ a compound that promotes feelings of empathy and close positive social feelings in users.

It is a strictly regulated Class A compound – classified as Schedule I in the United States.

However, MDMA’s regulated status shouldn’t discourage researchers from studying its effects, argue Malenka and co-author Boris Heifets, also at Stanford.

‘You’re trying to understand the different mechanisms of an experience,’ Dr Malenka argues.

‘Drugs like MDMA should be the object of rigorous scientific study, and should not necessarily be demonized.’

Malenka’s team has already begun preliminary studies to test MDMA’s effects in mice, and is writing a proposal to the National Institute on Drug Abuse for a larger project in concert with researchers who plan to tackle the human aspects of the study.

Studies using MDMA have to go through many rounds of paperwork and follow stringent safety measures to get approval, but Malenka’s message is clear: it’s worth it.

‘There are going to be certain areas of the brain in which MDMA’s actions are critical for its behavioral effects,’ says Malenka.

‘You can give it to human beings under appropriately controlled, carefully monitored clinical conditions and do fMRI and funcational connectivity studies, and you can begin to build up a knowledge base in an iterative fashion, combining the animal and human studies, where we start to gain more traction in understanding its neural mechanisms.’

While autism has physical causes, the use of MDMA would be purely psychological, to inspire empathy.

Malenka’s team has already begun preliminary studies to test MDMA’s effects in mice, and is writing a proposal to the National Institute on Drug Abuse for a larger project in concert with researchers who plan to tackle the human aspects of the study.

Studies using MDMA have to go through many rounds of paperwork and follow stringent safety measures to get approval, but Malenka’s message is clear: it’s worth it.

‘There are going to be certain areas of the brain in which MDMA’s actions are critical for its behavioral effects,’ says Malenka.

‘You can give it to human beings under appropriately controlled, carefully monitored clinical conditions and do fMRI and funcational connectivity studies, and you can begin to build up a knowledge base in an iterative fashion, combining the animal and human studies, where we start to gain more traction in understanding its neural mechanisms.’