MDMA Could Soon Receive FDA Approval — Scientists Having Been Working Towards This for Decades

A popular party drug could soon become a leading treatment for post traumatic stress disorder (PTSD).

A few weeks ago, researchers from the University of California at San Diego published positive results from a late-stage trial for the efficacy of MDMA, also known as ecstacy, in treating serious PTSD. The positive results came in late stage clinical trials, setting the stage for the Food and Drug Administration (FDA) to issue approval for the drug.

They found that MDMA reduced symptoms of PTSD 60% more than talk therapy without MDMA over a two year study period.

“It confirms MDMA works,” Matthias Liechti, M.D, a Swiss pharmacologist, told Nature. 

MDMA is much older than the underground rave subculture it’s mostly known for. Short for 3,4-Methyl​enedioxy​methamphetamine, it was synthesized by the German pharmaceutical company Merck as a possible medication to stop abnormal bleeding in 1912. However, they gave up on it in 1957 after decades of animal trials, concluding that it wasn’t worth the hassle. 

In 1976, the drug regained interest for therapeutic use, this time as a drug to use during therapy sessions to help patients open up and become more receptive to psychotherapy. It was also around this period that it started to be used as a party drug, and this led to the Drug Enforcement Agency ban its use in 1985. 

Since then, trials for efficacy in psychiatry have been agonizingly slow. The Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored the first trial for its use in treating PTSD in Spain in 2000, but that study was shut down in 2002 due to political pressure, according to MAPS. Meanwhile, in the United States, MDMA wasn’t approved as an investigational new drug until 2004. 

Two decades later, experts are finally saying that approval from the FDA is on the immediate horizon.

“I think this time next year, psychiatrists will be prescribing MDMA in the US,” Brian Barnett, MD, a clinical psychiatrist who oversees psychedelics research at the Cleveland Clinic, told The Messenger.

How MDMA can treat PTSD

One of the ways it works, according to David Dadiomov, PharmD, an assistant professor of clinical pharmacy at the University of Southern California, is that it can suppress the fear response in the brain. 

Many patients dealing with trauma have trouble revisiting traumatic events because of fear responses, so dampening this response may help patients remember what happened without a fog of fear and anxiety surrounding it. 

It is also thought to improve neuroplasticity, or the ability of the brain to change and adapt, according to Dr. Barnett. This is helpful for PTSD patients who have not been responsive to other kinds of treatment—by shaking things up, so to speak, MDMA can help them break out of existing thought patterns. 

To be clear, a round of MDMA-assisted therapy can last months, with comparatively few sessions actually involving the drug. Multiple preparatory sessions are required to establish trust between a patient and a therapist, and so the therapist can better understand what the patient needs. 

After the session that actually uses the drug, the protocol involves what Dr. Barnett calls “integration sessions” where the therapist and patient talk through what happened in the MDMA-assisted session. 

In short, it’s not a quick fix; it’s a long, methodical process that takes hours of therapy before MDMA even enters the room.

Other PTSD treatments

Other treatments for PTSD therapy include cognitive behavioral therapy, prolonged exposure therapy, and cognitive processing therapy. There are also drugs that can be used, such as Prozac. 

However, not all patients will respond well to these therapies, and MDMA can be another option for patients who have exhausted all other options. 

The caveats of MDMA-assisted therapy

While Dr. Barnett said that there are some patients who may pursue this option as a first step, it is likely that most insurance companies will require that the patient has failed to respond to more conventional means, like cognitive behavioral therapy.

Additionally, right now, the drug has only been tried in certain groups of people. 

Those with bipolar disorder and schizophrenia, or people with family histories of those disorders, have not been included in the studies, due to a concern that the drug could worsen existing mania or psychosis. At a population level, according to Dr. Barnett, there is no evidence that MDMA increases rates of psychosis, however, we don’t know the risks for individuals because we simply haven’t done those studies. 

According to Dr. Dadiomov, people with substance use disorders have not been included in these studies either for similar reasons. On a population level, there is not convincing evidence that it increases the risk of substance abuse, but on an individual level, that risk is yet to be assessed.

MDMA-assisted therapy also hasn’t been studied in individuals with PTSD and severe suicidality, or in people with heart irregularities like high blood pressure because MDMA can increase one’s heart rate.

What comes next?

Assuming that the FDA goes ahead and approves its use, MDMA will not suddenly become widely available. The agency will be specific with what they are approving it for, including use settings and dosages. 

However, once the drug is FDA approved, it will be available for doctors to be able to prescribe off-label. This doesn’t mean that anyone can ask their doctor for MDMA, but it does mean that people with bipolar disorder or other disorders may be pointed towards MDMA-assisted therapy after a conversation with their providers over the risks and benefits. 

Dr. Barnett said that doctors will probably also be conservative in doling out the treatment, at least at first.

The Cleveland Clinic doctor also stressed the question of accessibility; this therapy regimen will not be cheap. One study calculated that three 90-minute therapy sessions, three eight-hour MDMA (or placebo) sessions, and nine 90-minute post-MDMA (or placebo) psychotherapy sessions cost more than $11,000 per patient. There is also the possibility of insurance requiring patients to have failed other, possibly expensive, treatment avenues before trying this one.

“This is going to be a treatment with very limited access at the beginning,” he said. 

“There are lots of important questions about health equity and minorities being able to access this and people who are living in poverty. I think that's one of the most important kinds of issues going on with the future of psychedelic medicine at this point.”

But both experts were very excited about the possibility of offering a new option to patients who haven’t found something that works for them. 

“This has the potential to really help a lot of people that are afflicted with PTSD,” said Dr. Dadiomov. “It's very encouraging.”