USA: MDMA Inches Toward FDA Approval for the Treatment of PTSD

Emerald Magazine reports…

The drug 3,4-Methylenedioxymethamphetamine, also known as MDMA or ”Molly,” is a schedule I drug with no current medical use, according to the U.S. Drug Enforcement Administration (DEA). However, a recent study conducted by Jennifer M. Mitchell, Michael Bogenschutz and 36 other pioneers in therapeutic studies, stands to challenge that classification. More specifically, the researchers are showing that MDMA-assisted therapy is nearly twice as effective as therapy with a placebo in the treatment of Post-Traumatic Stress Disorder (PTSD).

The Phase 3 Trial

The study, titled MDMA-Assisted Therapy for Severe PTSD: a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study, showed that combining MDMA use with therapeutic treatment was extremely effective at relieving PTSD.

At the start of the study, researchers randomly assigned 46 of the 91 participants to receive MDMA-assisted therapy. They assigned the other 45 to receive placebo treatments.

Eighteen weeks after the start of the study, 67% of those that received MDMA-assisted treatment showed lessened symptoms to the point where they were no longer diagnosable with PTSD. Only 32% of participants assigned to placebo experience such results.

By the third session, one-third of participants assigned to MDMA-assisted treatment met the criteria for PTSD remission. However, only 5% of placebo participants had reached that milestone, according to the study.

What’s Next?

The publication of this study is good news for the use of MDMA-assisted therapy in PTSD treatment.

After phase 3 testing of a drug or treatment, all that remains is applying to and receiving approval from the U.S. Food and Drug Administration (FDA). Easier said than done, to be sure. But with promising results such as these, it’s entirely possible that the FDA could approve this revolutionary treatment within the next year or so.

If the FDA approves MDMA, officials would have to reclassify it, according to the DEA. They will most likely reschedule it as schedule II, or a controlled drug for medical use. This means that MDMA will still be illegal outside of its medical applications. So no great upheaval of drug enforcement will result.

However, the impact of FDA approval cannot be understated. It could subsequently open many doors for further study on the effects and medical application of MDMA and other psychedelic drugs.

Read the full report at

MDMA Inches Toward FDA Approval for the Treatment of PTSD


The Study


Primary Sponsor

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