MDMA and FDA approval, what are the chances?

[Gibson]

«MAPS' highest priority project is sponsoring Food and Drug Administration (FDA) drug development research into 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of posttraumatic stress disorder (PTSD). FDA has designated MDMA-assisted therapy for PTSD a Breakthrough Therapy, and has come to agreement with MAPS on Phase 3 protocol designs after a rigorous Special Protocol Assessment (SPA) process. MAPS' goal is to develop MDMA-assisted therapy for PTSD into an FDA-approved prescription treatment. The Phase 3 trials are expected to be complete in 2022, meaning that FDA could approve the treatment as soon as 2023.» (source)

Your thoughts? Optimistic about the novel therapy, or think it'll fall flat, or something else?

At the time of writing, there are currently twenty clinical trials on PTSD, chronic PTSD and treatment resistant PTSD on clinicaltrials.gov, where they use MDMA-Assisted Psychotherapy.

 

[Eagle3]

Not only do I hope it gets approved, I'mma be waiting in line for treatment! Been seriously considering either Ketamine or MDMA for my issues, since I can't take conventional psych meds for depression, pain, and PTSD. I'm hoping against hope that it gets approved and I'll be able to afford it!

 

[Tinyflame]

I wouldn't do it, for me. Have way too many trust issues for it, I think. But I appreciate others could feel differently. But I would want to feel it's 100% my choice to disclose (or not).

 

[Freida]

The VA has been studying it directly the last couple years and plans are to make it available this summer because the results they are seeing are amazing. Told my t to sign me up!

 

[Friday]

As it was in active therapeutic use for decades pre-classification, IE we have metric shit tons of longtudinal data (which is virtually unheard of in the US, we have to use socialized med countries studies for longitudinal info 99% of the time); AND results in clinical trials for PTSD have been off the charts amazing? Just a question of time until it’s approved, IMO.

 

[coraxxx]

I hope it gets approved. I’m not from the US but it might have an impact in Europe. MDMA was the only thing that gave me a sense of what belonging means. I don’t take it often and not in massive doses. But from the first time I had it I didn’t forget the experience and I could extend that knowledge to the rest of my life. I have other treatments running and they sorta work, but from what I know of this drug personally I understand the big potential against the sense of disconnection and the general dysphoria.

 

[EveHarrington]

What symptoms does it help with specifically? This would be the determining factor for treatment, not just the fact that it helps treat PTSD.

 

[coraxxx]

PTSD involves a deficit in the extinction of fear conditioning. As ar esult, a combined treatment of MDMA and psychotherapy may be especially useful for treating PTSD because MDMA can attenuate the fear response and decrease defensiveness without blocking access to memories or preventing a deep and genuine experience of emotion.

While the specific mechanisms involved are not completely understood, MDMA is known to significantly decrease activity in the left amygdala .Studies in healthy volunteers suggest that MDMA alters recognition of and responses to expressions of facial emotion in ways that foster greater rapport, such as making facial expressions of positive emotion easier to recognize and negative emotions harder to detect.

This action is compatible with reported effects of MDMA such as reduction in fear or defensiveness and it contrasts with the stimulation of the amygdala observed in animal models of conditioned fear, a state similar to PTSD. Current studies of MDMA-assistedpsychotherapy suggest that this reduction in stress-induced activation of the amygdala may be enhanced by interaction with the therapists during and after the MDMA experience.

(source: MAPS Manual for MDMA-Assisted Therapy), sec. 1.1

 

[Freida]

From what I've read it puts the brain into a more receptive state so you can access the memories without fear. Once you can see the memories as memories and not real time trauma, it starts to disengage the entire ptsd process. It's like a jump start in your brain to separate emotions and memories.

 

[EveHarrington]

From what I've read it puts the brain into a more receptive state so you can access the memories without fear. Once you can see the memories as memories and not real time trauma, it starts to disengage the entire ptsd process. It's like a jump start in your brain to separate emotions and memories.

Oh, ha, sign me up! (I’ll do more research!)

 

[Friday]

What symptoms does it help with specifically? This would be the determining factor for treatment, not just the fact that it helps treat PTSD

It’s Chemical-Trust.

At recreational levels it’s also

- a combination of childlike sense of AWE and wonder, married to the unadulterated pure joy jumping off a swing, or ice cream, or rolling down hills, or a basket of puppies.

- sad/angry/similar things are still able to be felt but just at the cusp where the bad thing goes away & is replaced with a sense of _______ (comfort, belonging, satisfaction, catharsis, acceptance, resolution, transforming one thing to another, etc.) Picture a kid who sees someone else really sad, and comes up to them also sad for them and then after patting them gently breaks out into huge GRIN, or gives them a giant hug, and then they both laugh and are off playing. It’s the fluidity of very real emotions that are just about to become something else.

- Sensory explosion of all things good and wonderful. As someone with sensory schtuff, you probably know what I mean about the difference between putting on a shirt & NO get it off off off, versus an okay shirt but with the wrong “mood” attached, a shirt that provokes no reaction, and the sheer bliss of AH! Perfect! ...except? That sense of “perfect” feeling attaches to everything. From concrete and sandpaper to fluffy silky whatever. Colors are richer deeper brighter, lights are bedazzling, sounds are impossibly beautiful, movement is joy, people are amazing

- A profound sense of being alive.

At therapeutic levels??? All of ^^^that^^^ still exists. In a waaaaaaaaay more muted fashion. It just tints everything, or clarifies it, like the crisp fresh depth of a new black and white photo replacing the one that’s been fading in the sun for 30 years... instead of ...ultra high definition the whole world in color movie. Or taking a shower rather than plunging down a water slide into a pool.

But it still lasts for around 10 hours... and is NOT something anyone wants to be on 24/7/365. It’s not a maintenance drug (like antidepressants), nor an acute issue drug (like benzos). It’s just to facilitate therapy. Some rather monster marathon therapy sessions, for true.