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MDMA-assisted therapy for PTSD: A randomized, placebo-controlled phase 3 trial

nature.com

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Re: MDMA-assisted therapy for PTSD: A randomized, placebo-controlled phase 3 trial

#2
> There were no deaths or serious TEAEs [treatment emergent adverse event]. These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated.

Re: MDMA-assisted therapy for PTSD: A randomized, placebo-controlled phase 3 trial

#5
post #2

> There were no deaths or serious TEAEs [treatment emergent adverse event]. These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated.

But also

> Seven participants had a severe treatment emergent adverse event (TEAE) (MDMA-AT, n = 5 (9.4%); placebo with therapy, n = 2 (3.9%)).

Re: MDMA-assisted therapy for PTSD: A randomized, placebo-controlled phase 3 trial

#6
post #4

dupe: https://news.ycombinator.com/item?id=37524353

Thanks! but on HN, we don't count reposts as dupes if the story hasn't had significant attention yet. This is to give good stories multiple changes at getting attention.

This is in the FAQ (https://news.ycombinator.com/newsfaq.html) and there are past explanations at https://hn.algolia.com/?dateRange=all&page=0&prefix=true&que... if interested.

Re: MDMA-assisted therapy for PTSD: A randomized, placebo-controlled phase 3 trial

#7
Overall seems positive, some interesting pieces:

> The only measured exploratory covariate with a significant interaction with treatment was lifetime history of SSRI use, which was associated with improved efficacy of MDMA-AT (P = 0.02; Supplementary Table 5). Covariates significantly impacting the main effect were sex assigned at birth and baseline Beck Depression Inventory (BDI)-II score; female sex assigned at birth and baseline BDI-II score ≥23 were both associated with improved outcomes irrespective of treatment assignment (P This is an interesting outcome, particularly the SSRI usage

> Eight participants (MDMA-AT, n = 7; placebo with therapy, n = 1) experienced cardiac TEAEs, which included palpitations (MDMA-AT, n = 5 (9.4%); placebo with therapy, n = 1 (2.0%)) and tachycardia (MDMA-AT, n = 2 (3.8%)); all were mild.

Seems a bit concerning, but I have little to measure this against.

> superiority of MDMA-AT over SSRIs cannot be assumed without a direct comparison

I feel as though this should be done. Even though the results are promising they come with a significant safety risk for the participants who are essentially at the mercy of the administrator and could be easily subject to abuse.

That being said, for people with severe PTSD this is surely a godsend. Maybe we can mitigate the safety issue other ways.

Re: MDMA-assisted therapy for PTSD: A randomized, placebo-controlled phase 3 trial

#8
I've been hearing about this for a long time - probably since the late 1990s, so I'm surprised to see that it seems only in the last couple of years that there are phase three trials. I would imagine that the safety profile of MDMA is already well understood / fairly well researched in the 1950s and 1960s

Re: MDMA-assisted therapy for PTSD: A randomized, placebo-controlled phase 3 trial

#9
post #5
post #2

> There were no deaths or serious TEAEs [treatment emergent adverse event]. These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated.

But also > Seven participants had a severe treatment emergent adverse event (TEAE) (MDMA-AT, n = 5 (9.4%); placebo with therapy, n = 2 (3.9%)).

Yep! I do wish they clarified what exactly that means; perhaps I just missed it in my quick read.

Re: MDMA-assisted therapy for PTSD: A randomized, placebo-controlled phase 3 trial

#10
Even as someone who has used this recreational, I'm very sceptical about mdma for medical treatment.

I have seen smart people needing professional help for a very long time after using this too often. And too often is already every second weekend, because the body needs so long to restore the serotonine.

But maybe they are using very little doses? I can still not believe that taking this regularily is a good idea.

Edit: Sry for not reading it carefully enough to find the dosage.

Still 120-180 mg with only one month in between is a lot.

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