FDA Labels MDMA (Ecstasy) a ‘Breakthrough Therapy’ for PTSD

pile of ecstasy pillsThe U.S. Food and Drug Administration (FDA), which regulates prescription drugs and drug trials, has designated methylenedioxymethamphetamine (MDMA)—also known as ecstasy—a “breakthrough therapy” for posttraumatic stress (PTSD).

The new designation clears the way for researchers to begin Phase 3 trials of the drug. These trials, which could begin as early as 2018, will assess the drug’s clinical efficacy.

Is MDMA a Viable Treatment for PTSD?

Interest in MDMA as a potential treatment for PTSD has steadily increased. Current treatments for PTSD include psychotherapy, anti-anxiety medications, and antidepressants. However, these treatments often fail to address flashbacks and intrusive thoughts, leaving few options for people with severe PTSD.

The Multidisciplinary Association for Psychedelic Studies (MAPS), a professional advocacy organization, has conducted small trials of MDMA and other psychedelic drugs since 1986. A 2011 MAPS study looked specifically at treatment-resistant PTSD. More than 80% of participants who took MDMA saw clinically significant improvements, compared to just 25% who received a placebo.

MDMA’s designation as an illegal drug, however, stigmatizes its use. It has also made clinical trials more difficult. The FDA designation could change this.

The reclassification does not mean the drug will become widely available as a treatment, or even that the FDA believes it is an effective drug. MAPS will sponsor two Phase 3 clinical trials with 200-300 participants. If the results of those trials are promising, the long process of authorizing MDMA’s use as a prescription drug could begin.

Like all drugs, MDMA carries some side effects. It can elevate blood pressure, heart rate, and body temperature.

Street Drugs: An Alternative Treatment for Mental Health Conditions?

In a 2016 BMJ editorial, psychiatrist James Rucker urged the reclassification of psychedelic drugs such as ecstasy. While ecstasy is now the subject of further testing, some researchers are interested in the treatment viability of other illicit drugs. A small 2014 trial found Ketamine, an anesthetic that is also used as a street drug, could offer both immediate and long-term relief of PTSD symptoms. Another 2014 study found Ketamine might also be effective in treating depression.


  1. FDA grants breakthrough therapy designation for MDMA-assisted psychotherapy for PTSD, agrees on special protocol assessment for Phase 3 trials. (2017, August 26). Retrieved from http://www.maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials
  2. Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., & Doblin, R. (2011). The safety and efficacy of ±3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: The first randomized controlled pilot study. Journal of Psychopharmacology, 25(4), 439-452. doi:10.1177/0269881110378371

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  • Julia

    September 5th, 2017 at 2:52 PM

    Although it might be difficult to accept for some people, I think that there could actually be some validity to these studies which are proving over and over again that something valuable can be obtained in these substances which have in the past been seen as totally wrong.
    So maybe we have to all be willing to expand our minds a bit, open them up to the fact that we often have to go outside oft he box to look for things that can help us and not be so rigid in our thinking all the time.

  • sadie r

    September 9th, 2017 at 8:15 AM

    It can be very challenging to change someone’s mind about substances like this, given that all most of us have ever heard is how bad they are for us.
    How can they be both bad and good at the same time?

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