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The Carlat Psychiatry Podcast

MDMA: What Went Wrong Part 2

The Carlat Psychiatry Podcast

Pocket Psychiatry: A Carlat Podcast

Health & Fitness, Mental Health, Medicine, Alternative Health

4.8440 Ratings

🗓️ 17 June 2024

⏱️ 27 minutes

🧾️ Download transcript

Summary

An FDA panel just rejected MDMA assisted therapy. We look at the reasons why, and what this means for the future of psychedelic therapy. CME: Take the CME Post-Test for this Episode (https://www.thecarlatreport.com/blogs/2-the-carlat-psychiatry-podcast/post/4742-mdma-what-went-wrong-part-2)Published On: 06/17/2024Duration: 25 minutes, 59 secondChris Aiken, MD and Kellie Newsome, PMHNP have disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.

Transcript

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0:00.0

Did boundary violations sync MDMA assisted therapy, or was there something more?

0:06.5

In part two of our series, we look at what else went wrong.

0:13.6

Welcome to the Carlet Psychiatry Podcast, keeping psychiatry honest since 2003.

0:19.2

I'm Chris Akin, the editor-in-chief of the Carlisat Psychiatry Report.

0:22.6

And I'm Kelly Newsom, a psych-n-p, and a dedicated reader of every issue.

0:30.6

First, an apology.

0:32.6

We announced in the paper journal that we'd feature an interview with Kyle Greenway on

0:36.6

Catamine-assisted

0:37.8

therapy last week in our June 10th podcast. That has been moved to June 24 to make room for the

0:44.9

breaking news on MDMA. This month, an FDA panel voted to reject MDMA-assisted psychotherapy

0:53.4

for PTSD. That doesn't mean the case is closed.

0:57.8

The panel is an independent group of 11 scientists, clinicians and patient advocates who advised the

1:03.2

FDA. The FDA will make their final decision in August, and while there's still a chance for

1:08.6

approval, we're not optimistic. 90% of the panel members voted against it, and while there's still a chance for approval, we're not optimistic.

1:16.1

90% of the panel members voted against it, and the agency usually follows their advice.

1:22.3

Sexual boundary violations, which we covered last week, were one of the reasons for the fail. Last year, we warned about this potential in a special issue on psychedelics,

1:27.5

but we didn't anticipate it would happen under the registered eye of the clinical trial.

1:32.6

But that was not the only problem that sank MDMA.

1:36.0

Another was functional unblinding,

1:38.2

which means that even though this was set up as a double-blind trial,

1:41.5

patients and the therapist could usually tell who got the placebo.

1:52.9

Imagine that you sign up for an MDMA trial, and the investigator tells you that you're going to get either MDMA or placebo.

...

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