VA’s MDMA Clinical Trials for PTSD

| May 15, 2024


Psychedelic therapy data ‘speaks for itself,’ VA official says

By Zamone Perez

The Department of Veterans Affairs’ top health official on Friday said the agency is prepared to spend “at least in the millions” of dollars on clinical trials of psychedelic therapies, pending a U.S. Food and Drug Administration decision on midomafetamine, or MDMA, assisted treatments expected later this year.

VA Under Secretary Shereef Elnahal’s comments were delivered to conference attendees during a conversation with Jason Pyle, executive director of Healing Breakthrough, an organization working to treat veteran PTSD through MDMA-assisted therapy.

Elnahal discussed how the VA will play a pivotal role in answering more specific questions surrounding psychedelic therapies, such as the extent of treatment necessary to have an impact on veterans.

Further researching just how intensive these therapies have to be will better prepare the VA to respond to the surge in demand they expect following potential approval by the FDA, Elnahal said.
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“This initial request for proposals is supposed to be the spark that fuels even more research,” Elnahal said. “Chances are that — because of the similar mechanisms of action, similar effect areas in the brain — we can see unique benefits of some of these other compounds. We’re proving the case that the federal government is no longer afraid to engage in this.”

A second phase III trial by Lykos Therapeutics, formerly the Multidisciplinary Association of Psychedelic Studies Public Benefit Corporation, found more than 86% of participants who received the MDMA-assisted therapy for PTSD experienced “clinically meaningful” improvement 18 weeks after starting the trial.

More than 71% of participants who participated in MDMA-assisted therapy no longer met the diagnostic criteria for PTSD at the end study, compared to just over 46% of participants who had the placebo plus therapy. The VA is currently conducting 13 multisite clinical trials, Elnahal told the audience.

Military Times

I’m an any-port-in-a-storm type, so if it helps some folks all well and good. While these numbers seem promising, finding current cognitive behavioral therapy and medication results data for comparison is challenging. National Institute of Health reports up to 70% of PTSD patients achieve clinically meaningful symptom improvement post treatment. Whatever that means and however it’s measured.

Category: Veteran Health Care

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KoB

“Better living thru chemistry?”

Hey, if it works it works.

Anonymous

Fifty years of people abusing MDMA got in the way of this– thank you, hippies!

RCAF-CHAIRBORNE

Fifty years of drug prohibition got in the way of this…..thanks DEA

Anonymous

True, which spitefully happened after all those damn hippies got into it.

RCAF-CHAIRBORNE

Fair enough

Green Thumb

Keep in mind, as with Big Pharma, these folks have a vested interest in seeing this “through”.

The name alone spooks me. And I am sure they are running a developmental training protocol (study) in tandem on how to deliver the intervention and accurately interpret results.

No to mention PTSD exposure (or otherwise) is not a one-size-fits-all problem.

Point being, another group looking for the “pill” – just not small and white – for the cure.

5JC

Some people just won’t smoke weed or take their oxy. For them we now have a third option to be blasted and useless all day.

26Limabeans

“looking for the “pill” – just not small and white”
Sildenafil is white but not small.
Some people report seeing blue flashes but don’t care.
Big Pharma is making big bucks on big dicks.
If they can do the same with shrooms they will most certainly
let (get) the VA in on it.

Anonymous

“Oh, Doctor, please, some more of these,”
Outside the door, she took four more…

Last edited 6 months ago by Anonymous
President Elect Toxic Deplorable Racist SAH Neande

So long as it’s a custom fit therapy for the patient, not a one-size-fits-all

BennSue

There’s a difference between masking the pain and dealing with it. If people do not deal with the events that led to a PTSD diagnosis, they’ll never properly recover. If medicine can help, I’m for it, but it’s not a real solution.

timactual

“recover”?

I think “cope” would be a more accurate word.

And pharmaceuticals and alcohol do have their downside.

fm2176

They’ve been trying alternative treatments for quite some time. I was at Walter Reed waiting for an Airborne physical back in ’06 when a cute young lady in a lab coat approached me to ask if I had time to complete a questionnaire. Naturally, I did, and a few days later I was contacted to see if I was willing to meet with a psychologist to be screened for an experimental PTSD study treatment. It helped that I had the interview right after getting off of CQ and being up for over 30 hours. The psychologist told me I fit the criteria, and I went in for a few sessions of acupuncture. It seemed to help, but just before I completed the study, I got frustrated driving around Walter Reed looking for the ever-elusive parking space and decided I was done.

I still got my certificate of completion and placed it on my desk in the recruiting station in lieu of the atta-boys that my peers had. I need to find that. It may be the only thing I display from my time in service. 🤨

Green Thumb

“I got frustrated driving around Walter Reed looking for the ever-elusive parking space”.

I remember those days well.

That is a cause of PTSD!

11B-Mailclerk

A certificate for enduring pricks.

Perfect.

RCAF-CHAIRBORNE

So……..you’re NOT allowed to hump the therapist?

Anonymous

Correct. Though it would make many people (likely to include the therapist) happier, it wouldn’t do much for resolving PTSD.

Last edited 6 months ago by Anonymous
RCAF-CHAIRBORNE

I have seen people do some pretty…umm…embarrassing things on MDMA. Not sure if pharmaceutical grade MDMA would be any different, but it should be interesting.

5JC

Rules, schmules, three of my NCOs were banging the therapist during their Peety S. Dee counseling sessions in Iraq until she got knocked up. Shen then had to go home and explain it to her soon to be ex-husband.

Let me tell you what though. I don’t know if it cured their condition or not but they sure seemed relaxed and motivated for duty after every time she visited.

11B-Mailclerk

Sometime I think Army-provided brothels would solve a bunch of problems.

timactual

“Bordels Mobiles de Campagne or Bordel Militaire de Campagne (both abbreviated to BMC) were mobile brothels used during World War I, World War II and the First Indochina War to supply prostitution services to Frenchsoldiers fighting in areas where brothels were unusual”
https://en.wikipedia.org/wiki/Bordel_militaire_de_campagne

Vive la France!

Mason

They did until 2003!?!

RCAF-CHAIRBORNE

Djibouti was the last location if I’m not mistaken.
I don’t know about you, but Sub Saharan Africa is the LAST place I would want to visit a lady of the evening….and I like my ladies like my coffee. Dark, sweet, room temperature

Roh-Dog

A citizen should never be disabused the right to keep and bear [drugs. Lots of drugs].

What? I thought this was’Merica!

11B-Mailclerk

….one pill makes you larger ….. and one pill makes you small……

Sam

The VA should ask the real experts. Mention “Stargate.”

Jimbo

They must have done drug trials on FJB. Would explain a couple things about his speech.

timactual

“Psychedelic therapy data ‘speaks for itself,’”

It’s called auditory hallucinations.

Or so I am told.

Tallywhagger

I’m willing to give it a try.

HMC(FMF)Ret_87-10

One group is calling BS on the trials conducted by Lykos (likely a group of shroom heads).

From the first article:

“In comments filed after ICER’s first draft of the report was published, Lykos said the health technology assessment (HTA) body had NOT INCLUDED (emphasis added) “meaningful input” from groups representing patients, caregivers, and providers who have perspectives to share on the needs of those living with PTSD.”

…..aka we didn’t let anybody else know what we were doing or ask for input so that we can get those guvment bucks and cash in on suffering vets.

https://pharmaphorum.com/news/icer-raps-conduct-lykos-psychedelic-trial-ptsd

https://www.msn.com/en-us/health/other/studies-on-ecstasy-for-ptsd-called-into-question/ar-BB1mqjwD

11B-Mailclerk

Is the mission treating PTSD or relieving/curing PTSD?

Because folks making a living on the former might not be in roo much of a hurry to accomplish the latter.

timactual

If psychedelic drugs work on PTSD the incidence among Vietnam vets must be very low.