MDMA Moves One Step Closer to Phase 3 Clinical Trial

Successful clinical trials would lead to MDMA's removal from schedule I.


The Food and Drug Administration is likely to approve a phase three clinical trial of MDMA-assisted psychotherapy, according to the Multidisciplinary Association for Psychedelic Studies (MAPS), which met with the agency on May 11. A successful phase three trial–i.e., a randomly controlled, double-blinded study that demonstrates both efficacy and safety in a large patient population–would all but guarantee the drug's eventual removal from schedule I of the Controlled Substances Act.

"At the meeting, all of the FDA's concerns were addressed and no outstanding questions remain," MAPS reported after its sit-down with the FDA earlier this month. "There are no roadblocks to moving forward with Phase 3 as the FDA gave favorable feedback to MAPS and [MAPS Public Benefit Corporation's] responses to FDA questions."

The FDA will share official minutes with MAPS in mid-June, after which the group will re-submit its protocol and Statistical Analysis Plan. It expects both will be approved without objection.

The phase three trial for MDMA-assisted psychotherapy as a treatment for PTSD is expected to cost approximately $25 million, of which MAPS has already raised $10 million (none of it from government agencies or pharmaceutical companies.)

There's a lot at stake here. In addition to the outrageous criminal penalties associated with schedule I substances, MDMA has incredible potential as a treatment for a range of central nervous system disorders:

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  1. I wonder what will happen if it does get removed. I imagine the first time someone on MDMA coughs too loud the drug warriors will run out clamor for more regulation.

    1. That didn’t happen with loperamide, whose progress in steps from schedule 1 to OTC was documented by Sasha Shulgin.

  2. “Successful clinical trials would lead to MDMA’s removal from schedule I”

    And on to schedule 3, like testosterone, which is not even a drug but a hormone? Fuck the federal government and their drug war, straight to hell.

    1. Language please. You are implying that you would actually TOUCH the federal government and/or the War On Drugs ™ with your generative organ..

      I know I wouldn’t.

  3. $25M for a phase 3 (presumably multi-center) trial is an interestingly low figure, considering those usu. bandied about for getting a drug licensed by FDA, & that phase 3 trials are the most expensive step in the process. It strongly suggests that for-profit drug development jacks up costs enormously over not-for-profit work.

  4. I’ve experienced discouragement (including self-mischief and suicide endeavors) for a long time, yet it’s being controlled by drug, and I likewise have nervousness which is being controlled by an alternate prescription. do my homework for money

  5. The strange thing about the DEA and its drug classification is determining who they come to the classifications. Diamorphine, better known as heroin, is a pain pill, used in many countries, which would be a class two drug, in our country. The system seems to approach it in an arbitrary and capricious manner. Even worse, no research is allowed on class one drugs! The illegal production of heroin and Fentanyl are the biggest problem. People are dying because the system is not working! When it is possible to get illegal drugs into prisons, we fight it by putting more people in there! People are going to have to think outside of the box! In any classification MDMA is a form of amphetamine (class one) that needs researched! It , along with diamorphine and cannabis. should have never been determined to be of “no medical benefit”. And when it comes to potency, Fentanyl is many times the effectiveness of morphine. Yet, there is no argument that it is a class tow drug! It is too bad that this system seems to run more on gossip, and old wives’ tales, than on the science of medicine! Treating addicts with free morphine would be a lot cheaper than paying thousands of drug cops to keep putting people in prison. But, lest we forget, IT IS ILLEGAL! What needs to be reviewed is why are these drugs, really, illegal, at all.

  6. It seems to be a pretty good jobs program for people with minimal education. We keep a lot of people in prisons that need guards. They also need judges and lawyers to feed human fodder into the prison systems…….(‘-P….You know, the peons who can’t afford a “real lawyer”!

  7. determining “how” they come to the classifications

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