One rejection of MDMA therapy doesn’t mean it’s entirely useless in a mental health context

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The U.S. FDA has rejected a company’s bid to use MDMA as a PTSD treatment, but this isn’t the end of therapeutic psychedelics

Post-traumatic stress disorder can be a debilitating condition. There are very few effective treatments.

The question now is whether this rejection will be a setback for psychedelic drugs in general, or if the findings of some unusual research by an unusual company are simply an outlier. But the FDA advisory group expressed some serious reservations about the methodology, which made them doubt the results. Nine out of 11 committee members voted that the Lykos trials did not prove MDMA’s therapeutic effectiveness. In addition, 10 voted that its benefits did not outweigh the risks of using it.

Finally, there is the thorny issue of blinding. In typical randomized clinical trials, half the participants receive the drug being tested, and the other half receive a placebo. But with a psychedelic drug like MDMA, it’s fairly obvious to the participant if they have received a sugar pill. This is a significant challenge for all psychedelics research.

We also have to make a distinction between recreational and therapeutic use of these drugs. MDMA has been a staple of raves and dance parties since the mid-80s. As drugs go, it’s relatively safe.

 

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