US: FDA trials for MDMA assisted psychotherapy entering phase three

[aihfl]

CHARLESTON, S.C. It's the little things that Jon Lubecky appreciates now, like playing a board game with his family. But it wasn't always that way for the former Army sniper, who came home in 2006 after nearly a year in Iraq with a traumatic brain injury from a mortar attack and a nasty case of post-traumatic stress disorder (PTSD). Traditional treatments, including the use of antidepressants like Zoloft, were useless. "I went home, loaded a Beretta nine millimeter, put it to my temple, and I pulled the trigger," Lubecky said. "The greatest peace I have ever felt was that microsecond the hammer fell... I knew it was over." The gun malfunctioned, but he would try again and again. But that has now stopped, thanks to a unique therapy. Over three sessions, Lubecky spent six to eight hours under the influence of MDMA, the active ingredient in ecstasy. Finally, Lubecky was able to talk about his trauma and thus make progress dealing with it.

Rick Doblin runs the Multidisciplinary Association for Psychedelic Studies, or MAPS, a non-profit advocating for MDMA-assisted psychotherapy. "It starts by reducing activity in the amygdala, which is the fear-processing part of the brain, so that people's fearful emotions linked to trauma can be more easily recalled and processed," Doblin said. Once the drug produces feelings of safety, veterans can then access memories which had been crippling before. While one in three veterans found pills like Zoloft and Paxil effective in treating their PTSD, a study including 24 veterans showed PTSD was eliminated in 68 percent of vets treated with MDMA-assisted therapy and significantly reduced in the other 32 percent.

Lubecky's last suicide attempt was on Nov. 3, 2013. Sixteen months later, his MDMA-assisted therapy regiment was completed. So don't talk to Lubecky if you think that MDMA's classification as a controlled substance renders it inappropriate for treating PTSD. "If I told you, 'I have a treatment that eliminates tumors in 68 percent of cancer patients,' they'd pass a bill tomorrow legalizing it," Lubecky said.

MDMA-assisted therapy is now about to begin its third phase of FDA testing. That will take three more years and up to 300 more subjects. But if all goes well, MDMA will be available by prescription as early as 2021.

https://www.cbsnews.com/news/mdma-t...y-could-be-key-in-helping-veterans-with-ptsd/

 

[S.J.B.]

I'm glad to see this is moving along the pipeline. It seems to genuinely work quite well, which I guess is something that the psychotherapists who pioneered MDMA could have told you decades ago. Of course, controlled trials are necessary to make these claims stick, as they should be.

 

[ro4eva]

Sadly, I suspect it'll be halted due to concerns over neurotoxicity and the associated long-term effects. I hope I'm wrong though. I am confident that moderate MDMA doses in conjunction with carefully-supervised clinical settings may aid certain sufferers of treatment-resistant PTSD get their lives back on track.

 

[Legerity]

Interesting in seeing how this turns out. I suspect the potential benefits of this treatment outweigh the potential risks.

 

[pofacedhoe]

Sadly, I suspect it'll be halted due to concerns over neurotoxicity and the associated long-term effects. I hope I'm wrong though. I am confident that moderate MDMA doses in conjunction with carefully-supervised clinical settings may aid certain sufferers of treatment-resistant PTSD get their lives back on track.

neurotoxicity vs suicide

when there is risk to your patient it has to be less than the damage that no treatment would create.

basic ethics

annecdotally mdma is great for helping you get over deep emotional trauma's embedded in your subconcious

 

[ro4eva]

neurotoxicity vs suicide

when there is risk to your patient it has to be less than the damage that no treatment would create.

basic ethics

With respect, your framing seems somewhat fallacious though.

annecdotally mdma is great for helping you get over deep emotional trauma's embedded in your subconcious

Indeed - I can personally attest to that.

 

[dankhead88]

As far as neurotoxicity goes, would methylone or any other MD analogues serve a good purpose or substitution?

 

[S.J.B.]

I doubt that neurotoxicity will be an issue given the frequency and dosage in these PTSD trials.

 

[Dr. J]

Medications currently used for psychiatric treatment - which are often used much longer and for off label indications and at higher doses than intended/researched - certainly seem to present a more clear and present safety profile ?danger/threat? than a 3-5 spaced individual doses. And, if the Phase 2 results are to be believed/confirmed, there seems to be a demonstrably higher rate of treatment success than current medications.

Worth noting is that both GHB and methamphetamine/Desoxyn are legally available as Schedule II medications. Granted, GHB has incredibly tight restrictions/regulations to obtain and Desoxyn has only approximately 13,000 to 16,000 unique prescriptions written annually in the U.S. If these drugs - with their well known dangers - still have legitimate medical use, I think MDMA would be scheduled the same way with similar tight restrictions (e.g. one national pharmacy/registry to obtain. It would actually be easier to control manufacturing and distribution because of the lower number of ?pills/doses? and smaller qualifying patient population size.

Of course, the above could just as easily be used to argue for removing cannibis as a Schedule I drug, so anything?s possible.

Nonetheless, news of Phase 3 trials are promising and any embrace/acknowledgement of our government that previously under-reseached/non traditional/illicit substances (MDMA, LSD, Psilocybin, etc.) have real medical benefits is a huge step forward.

As an aside, without looking it up myself, does anyone know why MDMA was chosen or would be more efficacious than MDA?

 

[ro4eva]

Worth noting is that both GHB and methamphetamine/Desoxyn are legally available as Schedule II medications. Granted, GHB has incredibly tight restrictions/regulations to obtain and Desoxyn has only approximately 13,000 to 16,000 unique prescriptions written annually in the U.S. If these drugs - with their well known dangers - still have legitimate medical use, I think MDMA would be scheduled the same way with similar tight restrictions (e.g. one national pharmacy/registry to obtain. It would actually be easier to control manufacturing and distribution because of the lower number of ?pills/doses? and smaller qualifying patient population size.

Indeed, you are correct. And I believe that Benzoylmethylecgonine/Cocaine is also Schedule II - although I'm not sure what form(s).

Of course, the above could just as easily be used to argue for removing cannibis as a Schedule I drug, so anything?s possible.

I know this is somewhat off topic, but tomorrow (October 17th), Cannabis is officially legalized at the federal level for recreational use in Canada. Finally!

I suspect America may be compelled to follow soon thereafter, but who knows? For my American brothers and sisters who consume Cannabis, I sincerely hope that day comes soon.

As an aside, without looking it up myself, does anyone know why MDMA was chosen or would be more efficacious than MDA?

Perhaps the extra methyl group increases blood-brain-barrier permeability? That's obviously pure, unadulterated speculation (wink).