FDA Approves Final Stage of MDMA Drug Trials

Banned in 1985, the "empathogen" could be legally available as a psychotherapeutic catalyst as soon as 2021.



More than three decades after the Drug Enforcement Administration banned MDMA, federal regulators have approved research that could make the compound legally available as a psychotherapeutic catalyst by 2021. The New York Times reports that researchers studying MDMA as a treatment for posttraumatic stress disorder (PTSD) yesterday received permission from the Food and Drug Administration for Phase 3 clinical trials, the final step before approval of a new medicine.

The Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring the research, funded six Phase 2 studies involving a total of 130 subjects. Hundreds of subjects will participate in the next phase.

In one Phase 2 study, scores on the Clinician-Administered PTSD Scale fell by almost two-thirds, on average, among 19 subjects who underwent MDMA-assisted psychotherapy. A follow-up study found that the improvements generally persisted an average of almost four years later.

"It changed my life," an Iraq and Afghanistan veteran who participated in one of the Phase 2 trials told the Times. "It allowed me to see my trauma without fear or hesitation and finally process things and move forward." Another subject, a firefighter traumatized by "years of responding to gory accidents," said MDMA-assisted psychotherapy "gave me my life back."

The psychotherapeutic potential of MDMA, which enhances empathy, reduces fear, and encourages openness, was apparent back in the late 1970s and early '80s, when the drug gained a following among psychiatrists. But once it was dubbed Ecstasy and became popular as a party drug, its fate was sealed. Like marijuana, LSD, and psilocybin, it has only recently re-emerged as a subject of legitimate medical research.

Reason TV covers the MAPS-sponsored MDMA research:

NEXT: Challenge Grant Time in the Reason Webathon! Because We Still Treat Presidential Politics as if (Bad) Ideas Matter

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. Should be legal OTC

  2. Maybe if the same sort of trials to approve a drug were required to schedule it… Nah, that’s crazy talk.

    If people enjoy something, that’s all the proof you need to ban it.

    1. ‘Something, something, the haunting fear that someone, somewhere may be having a good time.’

    2. Calm Down Just Relaks – If This Sound Good For You – Popcorn First !!!
      Interested? Check – visit don’t forget to like & share
      Latest Update More HD Quality Movie Complete Available Here:
      ? ? ? ? ? ?
      Happy & Enjoy to Watch For Free

  3. “enhances empathy, reduces fear, and encourages openness”

    Sounds horrible

    1. It’s pretty awesome. The euphoria of great weed with no couchlock, the rush of invincibility you get from speed without excessive twitchiness, the light visuals of a threshold dose of shrooms. And sex on it is amazing as long as you don’t take so much that you kill your dick.

      The hangover sort of sucks, but just don’t plan on doing much the next day but bingeing Netflix and drinking water and you’ll be fine.

      1. ^^^^ I gotta party with this dude!

      2. ^^This has been my exact experience.

      3. The hangover from it sounds terrible. That’s the great thing about weed – there are really no consequences (usually slightly groggy in the morning but I’m fine after coffee).

        Still, I would of course try it.

  4. Did they also get approval to test the therapeutic potential of EDM, baby pacifiers, and neon plastic beads?

    1. After the tragedy that was testing the glow sticks, they just banned it all.

    2. and the type of women who go to those dances.

  5. So does any anybody have suggested music to listen to while testing this medicine?

    1. Tame Impala
      The Flaming Lips
      Spacemen 3

      1. Definitely Tame Impala. My favorite adventure music.

  6. So does any anybody have suggested music to listen to while testing this medicine?

    1. The squirrels apparently don’t.

  7. “But once it was dubbed Ecstasy and became popular as a party drug, its fate was sealed.”

    “the Drug Enforcement Administration banned MDMA”

    Who is the DEA? Any chance we can get a name attached to that? I will dig in a little and report back.

    1. It was the hero of personal freedom, Ronald Reagan.

      1. Nah. Shit like this happens while so-and-so is the head, and ultimately the responsibility falls on them. I have worked for the state and seen how this gets enacted. Most of the time the decision is made by some nameless, faceless career bureaucrat while the chief just signs off on it and he never knows what he signed. Try to dig in and find the person who actually spearheaded the effort and you just fall into a rabbit hole where everyone passes the buck and shrugs their shoulders. It’s maddening.

        I have looked at a dozen stories from the time and they all give the names of the people who invented, used, tested the drug etc. but on the banning all you get is ‘the DEA banned’, ‘the DEA rescheduled’ as if ‘the DEA’ is a person.

        Fine. If the DEA is a person then the DEA should be punished.

        1. Shit like this happens while so-and-so is the head,

          It’s pretty definitively John Lawn. He rather single-handedly Schedule I’ed MDMA. You could reasonably wave Reagan into the rogues gallery but he didn’t exactly Schedule the drug himself and it wasn’t until 1998 that it became an uncontested Schedule I drug. Much easier to point the finger at Lawn as the guy that lined up the dominos and started the whole thing rolling.

  8. by 2021?

    The government needs only 5 years of research done so some one can get a permission slip to put something in their own body.

    Hats off to MAPS, a great organization.

    People have the right to control their own body/mind without seeking permission from government .

    1. Calm Down Just Relaks – If This Sound Good For You – Popcorn First !!!
      Interested? Check – visit don’t forget to like & share
      Latest Update More HD Quality Movie Complete Available Here:
      ? ? ? ? ? ?
      Happy & Enjoy to Watch For Free

  9. Huh. Found this interesting little quote:

    “You understand what I’m saying? We knew we couldn’t make it illegal to be either against the war or black, but by getting the public to associate the hippies with marijuana and blacks with heroin. And then criminalizing both heavily, we could disrupt those communities. We could arrest their leaders, raid their homes, break up their meetings, and vilify them night after night on the evening news. Did we know we were lying about the drugs? Of course we did.”

    -John Ehrlichman, Nixon’s domestic policy chief

    I think the WOD has evolved from a political weapon to a pretense for armed robbery. Asset forfeiture seems to be the government’s only concern these days. Why do we put up with this shit?

    1. It’s all about power, pure and simple. It justifies a massive police state and mass incarceration. The state doesn’t need the resources it confiscates, it confiscates to punish and control. The drug war will end, it will serve out its useful purpose, and then the massive enforcement apparatus that has been assembled in its name will move on to…something else.

  10. Therapies that mitigate human suffering and enhance the pleasure of existence should never fucking be camped outside the thorny buttresses of societal walls guarded by anti-relief villains feverish with dictatorial eye gleams.

    Elite bliss unchained and unrestrained by goddamn dungeons lies within horizons so fucking nearby.

    The morbidly hairy asses of ultra-controllers and religious miscreants shit continuously on the pioneers of technopharma and hypernutrition.

    Unlace the fucking purest realities to a cosmos bristling with vast opportunities to elevate mankind and the dog of the future eats the basement door of today.

Please to post comments

Comments are closed.