Thursday, April 21

This Can't Be Good... MDMA to treat PSTD?

Just... no!  The amount of harm done will outweigh the amount of help provided to those hard-to-treat trauma survivors, is my layperson's opinion, as someone who has never done the drug, been around it much, and does not even know the depth of long-term, hard-to-treat PTSD sufferers.

First, do no harm.

It's just... common sense, right?  You don't pump people up with "ecstasy" to treat a vague diagnosis just because... you can.  

I pray the FDA has learned something from the overprescribed opioid  crisis that our country is just coming out of, and rejects legalizing the product for this purpose, after one clinical trial showed success.  Better to find better ways to treat those hard to reach, than to pump MDMA into the bodies of those who don't need the drug in their system with consequences to affect society as a whole.

My 2 cents.  Somebody is going to make money off this, and it is going to hurt society to have vulnerables diagnosed with PTSD prescribed this pill...

The psychedelic drug MDMA, sometimes called "ecstasy" or "molly," may help people suffering from post-traumatic stress disorder (PTSD) when paired with talk therapy, according to new results from a phase 3 clinical trial.

The preliminary data was presented at the American Chemical Society's (ACS) Spring 2022 meeting in late March. The study helps pave the way for more research on MDMA, formally known as 3,4-methylenedioxymethamphetamine. Plus, the researchers say U.S. Food and Drug Administration (FDA) approval for MDMA-assisted therapy for PTSD may be on the horizon as early as 2023. Such a change could help millions.

"It definitely appears to be equally effective in people who are usually considered treatment resistant, so we're very excited to think that MDMA-assisted therapy is going to be an effective therapeutic in that hard-to-reach population," Jennifer Mitchell, PhD, the clinical trial's principal investigator and a professor of neurology at the University of California, San Francisco...

For the trial—the first of its kind for MDMA-assisted therapy for the treatment of PTSD—Mitchell and colleagues enrolled (only!)  90 participants with a severe form of the disorder. 

Participants received the "optimal oral dosage of MDMA"—a full dose, followed by a half dose an hour later—which had been previously determined in phase 2 trials, or a placebo. After the half dose, participants attended an eight-hour psychotherapy session. They repeated the process twice, each a month a part. And they attended weekly therapy sessions in between. 

Two months after their final session, two-thirds of the participants who received MDMA and therapy no longer met the criteria for a PTSD diagnosis, while only one-third of the participants who received a placebo with therapy no longer met the criteria. The researchers said participants did not exhibit any signs of addiction, and MDMA side effects, such as nausea and jaw clenching, were minimal... 

Additionally, the American Psychological Association (APA) recommends cognitive behavioral therapy (talk therapy) for PTSD survivors. However, talk therapy on its own can be unhelpful, Geoff Bathje, PhD, a professor at Adler University and a psychologist at Sana Healing Collective, told Health.

"Talk therapy can be really triggering and activating when talking about your traumas," Bathje said. "MDMA really helps people stay regulated, stay present in their body, and stay connected to their therapist. So you can really see MDMA as a therapy facilitator."

It works this way because, according to Mitchell, MDMA is an empathogen. "It causes the release of oxytocin in the brain, which creates feelings of trust and closeness that can really help in a therapeutic setting," she said in the press release. 

Bathje, who was not involved in the clinical trial, said the number of people living with PTSD may be "grossly understated," citing the fact that patients are often misdiagnosed with depression, or a panic disorder, or a different mental health issue, when PTSD would be a more accurate diagnosis. He added that trauma of any kind—such as war, sexual assault, abuse, illness, or a car accident—can lead to PTSD, but explained that not everyone who experiences a trauma will have it. ...

He added that many people go to therapy because they're "stuck" in a pattern of behavior, emotion, thought process, or even a relationship that isn't working for them. 

"I think psychedelics are really good at temporarily disrupting those things that we're stuck in," he explained, "and allowing us to consider some new possibilities, and to try out some new possibilities of thinking and feeling and behaving...." * 

Just... wow!  Sounds to me like, "if you legalize it, the docs will be incentivized to find a market for it..." and diagnose more people as PTSD sufferers. 

Let's look at those numbers:  only! 90 participants in the study.  With ecstasy, 60 reported no more PTSD, while 30 on the placebo reported no PTSD in the same tire period, without the drug.

Would the FDA really be so stupid to legalize a "party" drug like that -- to put it on the market for docs to prescribe, and other people not on the prescription to potentially abuse -- based on the 30 people who  might not otherwise have been helped if left untreated?

If they do approve it for these medicinal purposed, like with opioids, I predict strong societal effects and abuses, especially amongst the rich kids who are able to get their hands on it through unwatched medicine cabinets and underground markets.

Don't LEGALIZE IT, not this one...

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* How about exercise? A change in diet habits?  A change in scenery? A vacation?  A new social activity?  Reading a good book?  Those can all be life-changing too... break you out of your doldrums and the routines holding a person back.

Maybe a good break-up even, a divorce as a last resort?  I can't imagine pumping someone with MDMA is the only way to break them out of their mental health troubles, or that overall the small number of people who potentially would be helped are worth the social problems that legally putting such drugs on the market is going to cost our country...

Do they have any smart people at the FDA who are going consider the future social costs? Just ... wow.  Blows my mind to think they might green-light this...