Clinical Trials Approved for MDMA treatment of PTSD

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Recently, the FDA approved phase 3 clinical trials using MDMA for the treatment of Post-Traumatic Stress Disorder (PTSD).

The first three phases of the clinical trials using MDMA for PTSD treatment began in 2004, and phase 3 is this final phase in the rigorous approval process. This means that MDMA is one step closer to becoming a legal therapeutic for PTSD! You can read more about the clinical trial process here.

What is PTSD?

Post Traumatic Stress Disorder (or PTSD) is a disorder that develops after a traumatic life-event. Events like war, abuse, car accidents, natural disasters, or a shooting are some of the many traumatic events that could cause some people to develop PTSD.

Typically, the symptoms of PTSD include hyperarousal, negative changes in beliefs or feelings, re-experiencing the traumatic event, and avoidance.

What is MDMA?

The chemical name 3,4-Methylenedioxy-methamphetamine, also known as MDMA, is a synthetic drug that alters a person’s mood, and their awareness.

You might be thinking that MDMA is just “Molly” or “Ecstasy.” However, they aren’t quite the same. Typically the illegal street drugs have MDMA in them, but they usually contain many other unknown and harmful substances.

How would MDMA be used?

The FDA has approved the phase three clinical trial for MDMA-assisted psychotherapy specifically. In this treatment, patients are given MDMA three times in total during therapy sessions, supplemented with weekly therapy without the drug.

Researchers have seen that MDMA has effects on the brain that make therapy more effective in treating PTSD. Essentially, the drug is allowing patients to comfortably process their pain.

The Multidisciplinary Association for Psychedelic Studies or MAPS is supporting these clinical trials. You can read more about their efforts here.

How soon could MDMA be available for PTSD treatment?

If phase 3 clinical trials go as planned, MDMA could be available for the treatment of PTSD with psychotherapy as soon as 2021.

You can read more about the previous phases here.

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