A group of scientists is launching the world’s first clinical trial of a combination of two psychedelic drugs, LSD and MDMA, to treat mental health conditions.
The New York City-based firm Mind Medicine will kick of its trial of the two compounds in January 2021.
It’s the latest study in a bold and growing body of research looking to employ drugs’ tendencies to increase feelings of empathy, connection and positivity to help treat disorders like depression, anxiety and PTSD where other medications have failed.
Already, the Food and Drug Administration (FDA) has approved esketamine, a nasal spray derived from the same molecule as ketamine – a potent anesthetic that sometimes illicitly used as a party drug another party drug – to treat depression.
MDMA – a compound known as ‘ecstasy’ or ‘Molly’ on the street – was given the FDA’s ‘breakthrough’ designation for treating PTSD.
But the new trial will be the first to combine MDMA and the infamous psychedelic drug LSD (a pairing known as ‘candy-flipping’ by hippies and ravers) in an effort to treat crippling mental disorders.
A new clinical trial by New York City startup Mind Medicine will be the fist to test whether the combination of party drugs LSD and MDMA could safely treat mental health disorders (file)
The study has enrolled 24 patients. At various points in the study, random groups within the trial cohort will get 100 μg of LSD (also known as acid) plus a placebo, the same dose of acid and 100 mg of MDMA, 100mg of MDMA and a placebo or placebo versions of each drug.
In total, the trial is slated to take one year.
LSD has been tested for many years to treat anxiety, depression, addiction and PTSD.
It is known as a ‘serotonergic hallucinogen,’ meaning that it can help to make more of the ‘happy’ neurotransmitter, serotonin, available to the brain.
Scientists have been testing the compound since the 1970s but, in recent years, researchers have gotten more serious and designed studies by more strict and serious protocols.
Some of these have suggested that people with anxiety or depression not only found relief that pharmaceutical treatments had failed to give them, but that the shift was ‘robust’ and long-lasting.
But critics have noted that the benefits were also seen in the placebo groups from some of those trials.
And while the wild hallucinations are thought to improve connections in the brain that promote empathy and feelings of interconnectedness, the psychedelic experience is not the same for everyone.
‘Psychedelic substances like LSD may also cause unpleasant subjective effects like negative thoughts, rumination, anxiety, panic, paranoia, loss of trust towards other people and perceived loss of control, depending on the dose of LSD used, the personality traits of the person consuming it (i.e. ‘set’), the environment in which it is consumed,’ Mind Medicine warns in their clinical trial description.
‘Inducing an overall positive acute response to the psychedelic is critical because several studies showed that a more positive experience is predictive of a greater therapeutic long-term effect of the psychedelic. Therefore, there is a need for methods which are capable of reducing bad drug effects while enhancing good drug effects to optimize a psychedelic experience.’
Mind Medicine CEO says that the trial is not to help ‘people have a better rave’ and will be testing the purely clinical potential benefits of the drugs, which are thought to make more serotonin and oxytocin available to improve mood and empathy
Put another way: the LSD experience is an intense one, for better or worse.
The Mind Medicine researchers hope that MDMA, an amphetamine derivative, can act like a booster for LSD, further increasing serotonin in patients’ brains.
‘MDMA is known to trigger oxytocin’ – colloquially known as the ‘love hormone’ – ‘release which may contribute to its effects to increase trust, prosociality, and enhanced empathy. The state of well-being induced by MDMA including increased activation and emotional excitation is known to be associated with a better response to psychedelics,’ they write in the trial description.
With its breakthrough designation, MDMA is ahead of LSD in terms of the approval typeline.
But the research team is confident that, if all goes as they hope, the benefits of the pair of drugs will overcome their stigma and schedule 1 DEA classification.
‘I think we’re most focused on as a company, and what the wider psychedelic-inspired medicine community is focused on, is what can be the outcome, forget the substance,’ Mind Medicine founder and co-CEO JR Rahn told Forbes.
‘If we can solve depression, anxiety, PSTD, does it really matter what the substance is? Shouldn’t we be more focused on the outcome and the benefit to society?’
As of yet, the trial isn’t targeted at any one of those disorders, but hopes to establish the safety of the drug combination and identify which condition it shows the most promise for easing.
And, Rahn added, the potential approval of these therapies will not be equivalent to legalizing them for partying.
When dosed with these drugs, a trial participant will ‘definitely have a hallucinatory experience,’ but it will be confined to a supervised study setting.
‘What we don’t want is people think they can take this every weekend. This is medicine, it should be treated as such,’ he told Forbes.
‘We are not developing this so people have a better rave.’
Link nguồn : https://www.dailymail.co.uk/health/article-8683109/First-trial-LSD-MDMA-set-test-safety-treatment-potential.html
