6 ms·

FDA agrees to expanded access program for MDMA-assisted psychotherapy for PTSD

142 points by OrgNet 7y ago

pg_is_a_butt 7y ago
Next step: Start an EDM festival named PTSD.
skunkworker 7y ago
Title is a little unclear, this is for an "Expanded Access Program", for individuals who are unable to participate in a clinical stage 3 trial. [1] "Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. " [1] https://www.fda.gov/news-events/public-health-focus/expanded-access https://www.fda.gov/news-events/public-health-focus/expanded...
jokowueu 7y ago
Click bait title
- TurkishPoptart 7y ago
  Agreed, how about we change it to: "FDA Agrees to Expanded Access Program for MDMA-Assisted Psychotherapy for PTSD"
  - dang 7y ago
    Ok, we'll use that. Thanks!
pmoriarty 7y ago
Here is what MAPS (the organization running the Phase 3 trials of MDMA-assisted psychotherapy and the same organization that applied for expanded access) has to say about this: [1] Donate to MAPS, people, if you believe in this! [1] - https://maps.org/news/media/8008-press-release-fda-agrees-to-expanded-access-program-for-mdma-assisted-psychotherapy-for-ptsd https://maps.org/news/media/8008-press-release-fda-agrees-to...
linuxftw 7y ago
There's an entire industry of psyche meds already. And they all have 'trials' proving their efficacy. Do those pills not work? Is it all a sham?
- xerox13ster 7y ago
  There's plenty of psychotropic medications, but none specifically for PTSD or CPTSD (most likely to be treatment resistant), of which I'm aware. I asked my psychiatrist and many of my friends have asked theirs and it's all similar answers. The only real medication for flashbacks is prazosin, a med that was originally a blood pressure medication that they found to be effective in blocking nightmares of a traumatic origin.
- jr46tjdr 7y ago
  Surprisingly, treating these kinds of conditions is difficult and many pills are not yet archetypes of a cure.
- cc81 7y ago
  MDMA has a very measurable effect but what is interesting if it can be combined with therapy. I saw a short youtube-video about one of those trials and the that patient they interviewed seemed positive (yes, I know n=1) because MDMA at that dosage was like she was just her best self and had the best day which made talking about her difficult experience with the therapist so much easier. Time will tell if it works long term and that those types of therapy sessions are positive but considering the type of drug (you only take it during therapy) and the dosages it seems pretty harmless.
- rincebrain 7y ago
  Many psychiatric medications exist, but since most of the things we group together as depression or generalized anxiety or others are some subset of a large number of possible causes, efficacy of these pills for any given person is rolling the dice, and takes O(months) to test a given med (for depression and bipolar meds, at least - O(weeks) per dose change). Plenty of people can testify to the efficacy of some of these meds for them personally, but even within families, having an immediate family member who responded well to a given drug is no guarantee it'll work well on you (though it's still better odds than without that data). Also, drugs+therapy leads to a better outcome, generally, than just drugs. So having more tools available, particularly a tool that improves the efficacy of therapy, is definitely a win.
campercoder 7y ago
I took Es in Prague around 2000. I was afraid I had done some brain damage with that stuff. Turns out, it was the very loud music that did the permanent damage. Now have ringing in the ears. So, hopefully they don't have the patients also listen to loud dance music.

142 points by OrgNet 7y ago

Next step: Start an EDM festival named PTSD.

Title is a little unclear, this is for an "Expanded Access Program", for individuals who are unable to participate in a clinical stage 3 trial. [1] "Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. " [1] https://www.fda.gov/news-events/public-health-focus/expanded-access https://www.fda.gov/news-events/public-health-focus/expanded...

jokowueu 7y ago

Click bait title

TurkishPoptart 7y ago
Agreed, how about we change it to: "FDA Agrees to Expanded Access Program for MDMA-Assisted Psychotherapy for PTSD"
- dang 7y ago
  Ok, we'll use that. Thanks!

pmoriarty 7y ago

Here is what MAPS (the organization running the Phase 3 trials of MDMA-assisted psychotherapy and the same organization that applied for expanded access) has to say about this: [1] Donate to MAPS, people, if you believe in this! [1] - https://maps.org/news/media/8008-press-release-fda-agrees-to-expanded-access-program-for-mdma-assisted-psychotherapy-for-ptsd https://maps.org/news/media/8008-press-release-fda-agrees-to...

linuxftw 7y ago

There's an entire industry of psyche meds already. And they all have 'trials' proving their efficacy. Do those pills not work? Is it all a sham?

xerox13ster 7y ago
There's plenty of psychotropic medications, but none specifically for PTSD or CPTSD (most likely to be treatment resistant), of which I'm aware. I asked my psychiatrist and many of my friends have asked theirs and it's all similar answers. The only real medication for flashbacks is prazosin, a med that was originally a blood pressure medication that they found to be effective in blocking nightmares of a traumatic origin.
jr46tjdr 7y ago
Surprisingly, treating these kinds of conditions is difficult and many pills are not yet archetypes of a cure.
cc81 7y ago
MDMA has a very measurable effect but what is interesting if it can be combined with therapy. I saw a short youtube-video about one of those trials and the that patient they interviewed seemed positive (yes, I know n=1) because MDMA at that dosage was like she was just her best self and had the best day which made talking about her difficult experience with the therapist so much easier. Time will tell if it works long term and that those types of therapy sessions are positive but considering the type of drug (you only take it during therapy) and the dosages it seems pretty harmless.
rincebrain 7y ago
Many psychiatric medications exist, but since most of the things we group together as depression or generalized anxiety or others are some subset of a large number of possible causes, efficacy of these pills for any given person is rolling the dice, and takes O(months) to test a given med (for depression and bipolar meds, at least - O(weeks) per dose change). Plenty of people can testify to the efficacy of some of these meds for them personally, but even within families, having an immediate family member who responded well to a given drug is no guarantee it'll work well on you (though it's still better odds than without that data). Also, drugs+therapy leads to a better outcome, generally, than just drugs. So having more tools available, particularly a tool that improves the efficacy of therapy, is definitely a win.

campercoder 7y ago

I took Es in Prague around 2000. I was afraid I had done some brain damage with that stuff. Turns out, it was the very loud music that did the permanent damage. Now have ringing in the ears. So, hopefully they don't have the patients also listen to loud dance music.