MDMA-assisted therapy for PTSD one step closer to FDA approval

The psychedelic drug MDMA, also called ecstasy or Molly, showed promise in a late-stage clinical trial for people with severe post-traumatic stress disorder (PTSD), inching the drug closer to medical approval for the condition, The New York Times reported.

The study, soon to be published in the journal Nature Medicine, included 90 people with PTSD who all underwent talk therapy during the trial; these participants included combat veterans, first responders and victims of sexual assault, mass shootings, domestic violence or childhood trauma, the Times reported. 

After two introductory sessions with therapists, each participant completed three 8-hour sessions at which they received either MDMA or a placebo. The trial was double-blinded, meaning neither the therapists nor participants knew which drug had been given. In the end, data showed that patients who received MDMA experienced greater relief from their symptoms than the placebo group, and two months after the treatment ended, 67% no longer met the diagnostic criteria for PTSD, whereas only 32% of the placebo group showed this level of improvement.

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"It's not the drug — it's the therapy enhanced by the drug," Rick Doblin, senior author of the study and director of the Multidisciplinary Association for Psychedelic Studies, a nonprofit research group that financed the clinical trials, told the Times.

MDMA, short for 3,4-methylenedioxy-N-methylamphetamine, may enhance the effects of talk therapy through several mechanisms, Live Science previously reported. The drug increases levels of serotonin in the brain, a chemical known to modulate mood; MDMA also increases levels of the hormones oxytocin, thought to enhance feelings of empathy and trust, and prolactin, linked to feelings of relaxation and satisfaction.

The drug also ramps up brain activity in the prefrontal cortex, key for information processing, and tunes down the amygdala, an almond-shaped brain structure involved in motivation and emotional behavior, such as that driven by fear and panic. 

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In combination, these effects likely help people with PTSD to get out of a hypervigilant, hyper-aroused state and into a mindset where processing trauma becomes more feasible, Live Science reported.

In addition, a mouse study, published in 2019 in the journal Nature, hinted that MDMA might push the brain into a malleable, somewhat child-like state, in which traumatic memories become destabilized and thus easier to work through, the Times reported. 

Whatever its exact mechanism, MDMA appeared to have a positive effect in the new clinical trial. What's more, though some trial participants who took MDMA experienced mild side effects, like nausea, the drug did not cause any severe side effects. 

Now, to be fully approved by the Food and Drug Administration (FDA), the MDMA-assisted psychotherapy must garner positive results in a second late-stage clinical trial, to replicate the results of the first trial, the Times reported. The trial is already in progress and includes 100 participants, meaning FDA approval for the treatment could come as soon as 2023.

Read more about the recent clinical trial in The New York Times. 

Originally published on Live Science.