FDA’s review of MDMA for PTSD highlights study bias and safety concerns

Xatolos@reddthat.com to News@lemmy.world – 153 points –
FDA’s review of MDMA for PTSD highlights study bias and safety concerns
arstechnica.com
43

You are viewing a single comment

I love mushrooms and I have PTSD. It's helpful. But, MDMA deconditions the fear response in most people far more effectively.

I've seen this first hand again and again and again. I grew up in the rave scene. Still in the burner scene. Still in the psychedelic scene.

MDMA promotes a sense of safety that's integral to treating PTSD. Your link is to a class summary? It doesn't support the numbers you just cited, as far as I could see. Unless you're referring to that one linked animal model study.

https://www.ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp

Here's a review of both. While psilocybin is of interest in treating PTSD, studies so far have been minimal.

As I said, MDMA is the gold standard for treating PTSD. That's why MAPS has invested so heavily into it.

Psilocybin is excellent for treating other things. End of life anxiety and depression, for example. John's Hopkins has invested a lot in research here.

I know the landscape. So, do the therapists and researchers who are studying and investing their time into it. MAPS put their money on MDMA for PTSD because they've seen it work better than other psychedelics. Rick Doblin is the protégé of Stanislov Grof, who was a leading LSD researcher before it was criminalized. These aren't shots in the dark or even educated guesses. But a painstaking effort to prove to the Feds that these drugs (both of them) need to be usable legally in psychiatry.

Okay, you can be personally excited about therapeutic MDMA possibilities without making up a "gold standard'.

The study I've linked to above is specifically for psilocybin treating PTSD with an 80% efficacy rate after one entirely safe dose for 6 to 12 months.

The link you've supplied, as far as I can tell, does not report conclusive results for MDMA treating PTSD.

MDMA is not a gold standard, it's one non-standardized psychedelic therapeutic possibility that is physiologically more dangerous with fewer studies, more risks and more time commitment, therapeutic prerequisites and necessary conditions than psilocybin, without the resulting necessary controlled and conclusive clinical trials providing evidence of effective treatment.

I stand by my original point of seeing little reason to focus on more dangerous, less effective therapies when we already have a completely safe, simpler and so far more effective therapy according to conclusive controlled studies and patient testimony.

I went back and carefully read what you linked I suggest you do too.

The number you are citing matches end of life anxiety studies. This is not PTSD and especially not chronic PTSD or complex PTSD such as my own, which I'm telling you from decades of anecdotal experience being in the psychedelic scene as well as research into the pharmacology of these medications, that MDMA is the gold standard for PTSD treatment.

That doesn't mean better treatments won't be developed or better drugs won't be developed in the future. Or that psilocybin and LSD don't have some efficacy in treating PTSD. But MDMA works better for the majority of people because it helps to relax the fear response in a way that classical psychedelics do not.

If I was to invest personal time and money into a classical psychedelic for PTSD treatment it would be mescaline. Which coincidentally is in the same class of chemical as MDMA.

And if I was to use psilocybin to treat PTSD I would do it at the tail end of an MDMA roll. Or as an adjunct to therapy. Depending on the PTSD, I would expect this to take multiple sessions and not be one and good for six months like in anxiety depression treatments.

PTSD, especially CPTSD from child abuse etc, is very difficult to treat. The success rates in anxiety and depression studies aren't necessarily applicable.

I'm glad you read that article closely, although they specifically mentioned that the scientists chose terminally ill cancer patients because the symptoms are identical to the symptoms of post-traumatic stress disorder, and some of the patients in that study had comorbid PTSD.

There are studies going on right now with victims of domestic violence and veterans with PTSD.

https://scholar.google.com/scholar_url?url=https://psyarxiv.com/t6k9b/download%3Fformat%3Dpdf&hl=en&sa=X&ei=0VZbZqyMM5--6rQP8ZCGMA&scisig=AFWwaebv_6yDRogfHBRZDmA5TMvP&oi=scholarr

https://scholar.google.com/scholar_url?url=https://bmjopen.bmj.com/content/bmjopen/13/5/e068884.full.pdf&hl=en&sa=X&ei=0VZbZqyMM5--6rQP8ZCGMA&scisig=AFWwaeYIYvNPeVNtPh_PlbCu_YN_&oi=scholarr

I like all the drugs you're suggesting, and I think people should be able to choose, although I maintain that the logical therapeutic focus should be on the one completely safe, easily administered and controlled drug proven to be effective in treating depression, anxiety, and especially the traumatic symptoms of post-traumatic stress disorder.

People should do whatever drugs they want, but that doesn't make whatever drug they want the best choice for therapy right now.

We have a safe drug for that already. Psilocybin. It has passed every test so far, and it's completely non-toxic.

I'm for research into both. I outlined why MAPS is focusing on it for PTSD. Because they've been using it for this in closed circles for decades and it works well in more cases.

I've died and been reborn on tryptamines a few times. I get how healing they are.

But navigating attachment disorders and trauma triggers in this life is much different, regardless of the symptomatology being similar on the depression/anxiety scale.

I'll read the papers you sent though. I do believe psilocybin can help with cptsd with the right set and setting and integration. I just don't believe the current therapy models and studies support the conclusions you're making about current efficacy.

Personally, I would take the risk with molly if it was available in psychotherapy. I'll save the mushrooms for personal exploration, enjoying nature, and other traditional medicine spaces. Where they work quite well and again we're just showing the feds Nixon was an asshole, ultimately. Because this is stuff psychotherapists have known for a generation.

Again, I'm all for anecdotal advocacy and the use of any drugs people prefer

I still don't see the point of focusing on more dangerous, less effective drugs as therapy when we have a perfectly safe, effective therapy available.

Maybe I'm missing something from what you're saying, because I didn't see any outline for why maps is focusing on Molly specifically for PTSD.

The proposed benefits you're talking about using Molly are already known benefits of taking psilocybin, athough psilocybin has a lower physiological risk and simpler therapy scheduling.

No problem with researching both, this is more a case of diagnosing a problem, having the solution, but making people wait by purposefully diverting our attention elsewhere while there is a more effective, risk-free solution available.

It seems at best a waste of time and at worst cruel to tell people we might decide to help them soon If they wait for unknown years while we look into different solutions instead of helping them directly at no risk with the safe, effective solution we have.

First of all, there's no we here. MAPS is a non-profit entity that survives mostly off private donations. So, it's their decision and the decision of people who support them to invest primarily in MDMA research because they believe it fits best with the Western treatment and insurance model for PTSD.

Your links are to a PTSD research proposal with zero results and positive results from small group (medicine circles) therapy. I do believe the medicine circle model is effective for treating PTSD, and mentioned it specifically in my last response.

That said, it's also a liability nightmare for insurance companies and much different than how talk therapy is usually conducted under the Western modality. Medicine spaces work through shared vulnerability. Allowing someone with trauma to integrate into the community. Raves and Burns and other psychedelic spaces create a similar setting for classical psychedelics to do this. And there's 'men's work' and many other methods that do something similar without drugs by creating ritual spaces for shared vulnerability.

MDMA helps a person lower their fear response. To be vulnerable without feeling vulnerable. This helps a person open up and feel safe in a more traditional talk therapy environment, which is how MAPS is using it.

I hope that helps clarify some things. And btw, Psilocybin comes with cardiovascular warnings too. Though, the danger of this is mostly in microdosing due to chronic use. But there is a danger there with it. And the cardiovascular distress from MDMA is comparable to many drugs the FDA has approved in the past.

I think the FDA board making a fuss about this is drug war bias and protection of antidepressant cash flows, tbh. And not about the cardiovascular issues at all. Though, the critique of the failed double blinding is valid, I know these aren't the only two phase 3 clinical trials that have been submitted either.

Of course you believe there's a "we", you are continually asserting your place within this research landscape to legitimize your anecdotes.

And again, psilocybin conclusively provides the same possible benefits you're proposing MDMA may provide without the physiological risk or burdensome therapeutic balancing and time management.

As for the "cardiovascular risks" of psilocybin, caffeine also comes with cardiovascular warnings and is twice as "toxic" as psilocybin, similar to the also more toxic MDMA.

It's fine if you personally like MDMA more and cool if you believe it helps you more than other therapies, but it doesn't make mdma more simple, safe or effective than psilocybin.

Maybe more research will come out later that legitimizes MDMA, or makes it as simple or as safe a therapy as psilocybin already is.

But not even a therapeutic process, let alone research on mdma is anywhere near conclusively positive yet, so I don't see the point of experimenting with more complicated unsafe medication when psilocybin is available, simple and safe.

Nothing you've linked has really backed up your assertions about psilocybin being great for PTSD so I'm going to stop replying.

Medicine circles personal exploration end of life anxiety etc.

I've explained why MDMA is better at relaxing the amygdala. The pharmacology supports this as does the current research. The papers you have linked don't really. One study in a small group setting, which I absolutely do believe would be beneficial for reasons I've mentioned earlier. And I also explained why the Western therapy modality conflicts with that model. And how that would make access difficult because of insurance issues. I. E. good luck getting insurance on guided group psilocybin journeys anytime soon. The U.S. health industry already struggles with access to group therapy and they're not giving everyone hallucinogens.

It's pretty clear you have blinders on when it comes to mdma, so I understand why you don't want to believe in the clinical results of a safer, more effective therapy for PTSD symptoms since that clashes with how you feel about MDMA.

It seems likely Molly will eventually become a less dangerous alternative to even more dangerous medications in dealing with certain symptoms, but I don't see the point in asking people to wait while we develop a less safe, more complicated therapy when we already have a cost-effective, completely safe and simple therapy available that conclusively treats those symptoms and provides the same benefits more dangerous therapies might provide in the future.

The therapy is already developed and has been being worked on since the '80s.

It's just waiting for approval. I don't understand why you're being so dense or pushing this point like it's one or the other.

They're both great in their own ways and the research for MDMA and PTSD is way ahead of psilocybin. I showed you in the article I linked above that you just completely dismissed while you continue to post irrelevant articles back.

I get that you think mushrooms are the cure all for everything but man you really don't understand the lay of the landscape here. Where it's at, where it's been, and what works within the context of Western medicine the best. For PTSD treatment.

Anyway I'm really done there's just too much projection in that last post for me to ignore.

The articles I provided to you are evidence of further ongoing trials specifically for PTSD using psilocybin, since you misread the original provided article. Follow-up and related studies are not irrelevant in therapeutic research, which you may recognize in all of your personally esteemed Molly studies.

The earlier article shows that psilocybin alleviates the PTSD symptoms you hope Molly will and provides the same benefits molly may provide eventually after clinical trials are completed.

Then you insult and make obviously incorrect assumptions about me instead of asking questions to remedy your ignorance.

You know what sam Jackson says about assumptions in the movie basic.

You're wearing blinders.

You personally like a less safe and less effective therapy. That is totally fine.

It's also very clear that it makes more sense to focus on a conclusively safe and effective therapy rather than an unsafe and less effective therapy.

I think people should do tons of drugs. That doesn't make all drugs safer or more effective in all situations.

I don't see the point of focusing on more dangerous, possibly effective future therapies when a safe, effective therapy is currently available for the same symptoms.

Pretty telling that "projection" is what's setting you off.