The first-ever application for midomafetamine, commonly known as MDMA, to be approved as a new therapeutic drug was submitted to the U.S. Food and Drug Administration (FDA) on Tuesday.
If approved, it would be the first psychedelic-assisted therapy, but this raises concerns for some experts.
Also known as ecstasy, MDMA is a synthetic drug that causes both hallucinogenic and stimulant effects.
MDMA is currently listed by the FDA as a Schedule I drug, meaning it is not accepted for medical use and has a high potential for abuse. The FDA’s approval of MDMA therapy would trigger its rescheduling to one that would acknowledge its medical use.
California-based MAPS Public Benefit Corporation filed MDMA as an assistance therapy for the treatment of post-traumatic stress disorder (PTSD). The drug is to be used in conjunction with other psychiatric services.
“Current treatments for PTSD are either medications or very prolonged psychotherapies. The psychotherapies have more sizeable effects, but the dropout rates are enormous because it involves repeated confrontation with the traumatic material, which is very difficult. Medications have pretty low efficacy. They fail to help many people, and when they do, the improvement is pretty modest,” Matthew Johnson, experimental psychologist and professor of psychedelics and consciousness research at Johns Hopkins University, told The Epoch Times.
MDMA Trials in PTSD
The new drug application (NDA) included results from two randomized, double-blind, placebo-controlled studies, both of which were published in the renowned journal Nature.Both studies tested 90 to 100 patients, half of whom were randomized to get MDMA while the other half were to get a placebo.
Participants were given three doses of either substance, along with psychotherapy. Both trials lasted 18 weeks.
Mr. Johnson, who was not involved in the study, calls it a “paradigm-changing level of efficacy.”
PTSD is a mental health disorder that occurs in people who have experienced or witnessed a traumatic event, series of events, or set of circumstances. The most common treatments are counseling and psychotherapy, aimed at helping individuals move past their trauma to heal.
MDMA therapy and psychedelic therapy “seems to work because patients can have a different access to their traumatic memories and can process those memories differently, take different perspectives, and see their life through a different lens,” Mr. Johnson said.
MDMA is both a stimulant and a psychedelic. The drug increases the levels of three neurotransmitters in the brain—namely serotonin, dopamine, and norepinephrine—to cause euphoric and empathogenic effects. Hence, users experience feelings of emotional communion and openness, which are thought to help patients engage in counseling.
The Safety of MDMA
MDMA can pose both physical and cognitive risks to those who take it.When taken outside clinical settings, the drug may be adulterated with methamphetamine, and there is no way to determine its potency.
MDMA can also increase one’s heart rate and blood pressure, which can stress the cardiovascular system.
While rare, overdoses on MDMA can kill. This may be caused by serotonin syndrome from increased serotonin in the brain, which can cause rapid heart rates, electrolyte imbalance, tremors, overheating, and seizures. People can also die from overheating, as MDMA impairs the body’s ability to regulate temperature, which can be worsened with alcohol consumption and being in hot and overcrowded environments.
MDMA can also cause hyponatremia, occurring when sodium levels in the body become dangerously low, since the drug reduces secretion of water while increasing thirst, leading people to overhydrate.
“It seems clear that at least at high enough dose and frequency, MDMA is neurotoxic in terms of long-standing changes in serotonin function,” Mr. Johnson said.
Since the drugs the participants consumed were not tested, it is unknown if the adverse reactions were linked to MDMA or other adulterants, Mr. Johnson said.
According to Mr. Johnson, it is also known from animal studies that the neurotoxic effects of MDMA are exacerbated by both heat and crowding independently, so how these results translate to clinical trials is uncertain.
“The question is whether we are likely to see this under the conditions of clinical treatment, which include controlled doses, limited use, and clinical monitoring in a comfortable (not hot and not crowded) environment. So far, I don’t think the evidence had shown such effects to show up, but it should be something that we keep in the radar and probe for,” Mr. Johnson added.
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