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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

#41

Post by chadd »

fshbbdssbbgdd wrote: post #16

I’m skeptical that a placebo control for MDMA can be valid. The effects of MDMA are pretty noticeable. The study actually asked participants if they thought they were on MDMA, and most answered correctly. If the participants can tell, it somewhat defeats the purpose of having a placebo control group.

Talked to a therapist at the MAPS conference who said that the way you know a patient is in the trial is about halfway through their therapy session, they inevitably say, "But enough about me, how are YOU doing??"

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

#42

Post by BurningFrog »

randomNumber7 wrote: post #31
ethanbond wrote: post #13

Earlier quoted context omitted.

If only there were some mechanism by which we could separate people's personal vibes and anecdata from actual scientific understanding... perhaps a series of clinical trials? History will look unkindly upon people who kept these substances out of the hands of people who need them because "I knew a guy once who did too much street MDMA and went stupid." Honestly, adopting that position in the face of a well-designed P…

Its not like "I know a guy". Its like common knowledge for people who do this stuff that it seriously fucks you up if you do this too often. Its like 100% guaranteed. I would not take this every day for a month even if you offer me a years salary. Every medic who thinks this is a good idea should do the self test in my opinion. The same goes for giving ritalin to kids, but that is a different story...

> I would not take this every day for a month...

From the article:

The treatment period consisted of three 8-h dosing sessions, in conjunction with therapy, spaced approximately 1 month apart.

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

#43

Post by samdcbu »

singingfish wrote: post #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

MDMA was first synthesized in 1912 by Merck. Merck and US Army did several animal trials in the 1950s, but by the end of the decade MDMA was shelved and thought to have no therapeutic benefit. It wasn’t until Sasha Shulgin rediscovered it in 1976 that its therapeutic benefits were discovered, at which point therapists and psychiatrists began quietly using it for psychedelic assisted psychotherapy. In July 1984 the DEA proposed making MDMA a Schedule I controlled substances, which led to outcry from practitioners who requested the DEA hold hearings to provide testimony on MDMA’s therapeutic benefits. While these hearings were ongoing, the DEA used its emergency scheduling authority in May of 1985 to place MDMA in Schedule I.

Animal efficacy and human safety trials of MDMA began in the late 1980s, and the first FDA-approved, placebo controlled, double blind phase I study was published in 1996.

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

#44

Post by Alupis »

andrekandre wrote: post #39
Alupis wrote: post #33

Earlier quoted context omitted.

> That being said, for people with severe PTSD this is surely a godsend. This seems a bit of a premature statement. The long term usage affects of MDMA use can be very costly, and I suspect long term use of something that provides artificial "feel good" emotion will have a tremendous downside for people who are already struggling with normality. > sex assigned at birth... female sex assigned at birth As an aside - in…

>> sex assigned at birth... female sex assigned at birth > As an aside - in a scientific article, this is insane language to use and really calls into question the assumptions and conclusions. i'm not really familiar with scientific writing, but why would that be insane language to use? what would be better?

It's not a scientific statement, it's a political statement. It doesn't matter if you agree with that political statement or not - it simply has no business being in a scientific report.

Injecting political ideology into what is supposed to be factual findings is wrong.

In scientific writing, such as studies like this - just the facts please. Anything else opens questions about motivations, conclusions, etc.

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

#45

Post by hentrep »

notamy wrote: post #9
prashp wrote: post #5

Earlier quoted context omitted.

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.

They detail this in the supplementary materials: https://static-content.springer.com/esm/art%3A10.1038%2Fs415...

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

#46

Post by tysam_and »

DrKavorkian wrote: post #35

Nature is the mecca of all science. MDMA will be approved by FDA, that's inevitable. Likely would require special licensing. Clinics will pop up all over the country and it won't be long before “off label” prescriptions will appear. The incidence of PTSD will suddenly rise and before we have a chance to quell the opioid epidemic another epidemic will replace it on the front pages of the news. Meanwhile the smart ones…

If you're talking about pairing an SSRI with MDMA, then perhaps you would perhaps be well-served by adding some reticence to the confident assertions made.

That pairing would be like a Clorox + Bleach pairing of the psychotropic world.

There is significant interest in the drug, and the culture largely is focused on appropriate administration measures. This is not a half-baked solution, MAPS has worked on this for decades.

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

#47

Post by sowbug »

DrKavorkian wrote: post #35

Nature is the mecca of all science. MDMA will be approved by FDA, that's inevitable. Likely would require special licensing. Clinics will pop up all over the country and it won't be long before “off label” prescriptions will appear. The incidence of PTSD will suddenly rise and before we have a chance to quell the opioid epidemic another epidemic will replace it on the front pages of the news. Meanwhile the smart ones…

MDMA isn't physically addictive. Could be psychologically addictive the way the lottery or Netflix is, but I doubt it's going to be giving oxycodone much competition.

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

#48

Post by derefr »

DrKavorkian wrote: post #35

Nature is the mecca of all science. MDMA will be approved by FDA, that's inevitable. Likely would require special licensing. Clinics will pop up all over the country and it won't be long before “off label” prescriptions will appear. The incidence of PTSD will suddenly rise and before we have a chance to quell the opioid epidemic another epidemic will replace it on the front pages of the news. Meanwhile the smart ones…

• MDMA is almost anti-addictive — the more often you take it, the less fun it is. MDMA acts on the brain almost as if it by "using up" some scarce resource inside the brain, that only gradually builds back up when not taking MDMA. If you try to take MDMA again the very next day after taking it, you just get a headache. There's a reason you don't hear about "MDMA junkies" the way you hear about heroin junkies.

• SSRIs and MDMA are counteractive; being on SSRIs suppresses the effect of MDMA. (And also, due to this, you can end up with serotonin syndrome on the come-down from MDMA.)

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

#49

Post by tysam_and »

fshbbdssbbgdd wrote: post #16

I’m skeptical that a placebo control for MDMA can be valid. The effects of MDMA are pretty noticeable. The study actually asked participants if they thought they were on MDMA, and most answered correctly. If the participants can tell, it somewhat defeats the purpose of having a placebo control group.

I would be surprised if that wasn't a glaring point for them, but you do control as best as you are able to.

This should be the second of two Phase III studies, which are pretty rigorous. Some drugs are just very hard to make a valid control for.

Some studies also use a drug placebo and a control group with a combination of interventions, or little to none at all, as best as I understand.

One can use statistics afterwards to help bolster claims of efficacy if a sham/placebo group is difficult to source.

This is my best understanding of the matter.

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

#50

Post by [deleted] »

sowbug wrote: post #47
DrKavorkian wrote: post #35

Nature is the mecca of all science. MDMA will be approved by FDA, that's inevitable. Likely would require special licensing. Clinics will pop up all over the country and it won't be long before “off label” prescriptions will appear. The incidence of PTSD will suddenly rise and before we have a chance to quell the opioid epidemic another epidemic will replace it on the front pages of the news. Meanwhile the smart ones…

MDMA isn't physically addictive. Could be psychologically addictive the way the lottery or Netflix is, but I doubt it's going to be giving oxycodone much competition.

[deleted]
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