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[Andrew Korenchkin]

Source: https://www.cbsnews.com/amp/news/fda-designates-mdma-as-breakthrough-therapy-for-ptsd/

After years of lobbying and experimental research, the FDA has granted "breakthrough therapy" status for the drug MDMA as a potential treatment for post-traumatic stress disorder. The designation does not mean the drug is FDA-approved, but it does ease the way for clinical trials to test its safety and effectiveness in patients with PTSD.


The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), which has been advocating and fundraising for MDMA research for three decades, announced the FDA's designation late last week. (The FDA told CBS News it does not publicly disclose information about which drugs qualify for breakthrough status, citing confidentiality, but said researchers or drug companies are free to do so.)

More commonly known as its street names ecstasy or Molly, MDMA (methylenedioxymethamphetamine) is a psychoactive drug that produces feelings of energy and euphoria, often followed by an emotional crash. In recent years, some in the scientific community have suggested it could have medical benefits, as well.

In previous phases of clinical trials, the drug was shown to offer significant relief to sufferers of PTSD, a mental health disorder characterized by nightmares or flashbacks and heightened anxiety or depression after experiencing or witnessing a terrifying event. It affects an estimated 8 percent of Americans, with certain populations, including those who served in the military, more vulnerable.

According to the FDA's website, a designation of "breakthrough therapy" simply means the agency will expedite the review of the drug and potential approval. The status is granted when "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement" over other available therapies.

In a press release, MAPS said the designation means "the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD."

MAPS, founded in 1986, has also been a long-time advocate for the medical use of drugs like psychedelics and marijuana. Its mission statement reads: "We envision a world where psychedelics and marijuana are safely and legally available for beneficial uses, and where research is governed by rigorous scientific evaluation of their risks and benefits."

In phase 2 clinical trials sponsored by MAPS, 61 percent of the 107 participants with chronic, treatment-resistant PTSD no longer had the disorder after two months of MDMA-assisted psychotherapy treatment. At a 12-month follow up, 68 percent no longer had PTSD.

The organization expects to begin phase 3 trials with a larger group of participants next year.

"For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way," Rick Doblin, founder and executive director of MAPS, said in a statement.

Amy Emerson, executive director of the MAPS Public Benefit Corporation (MPBC), adds, "our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly."

However, not everyone in the scientific community is enthusiastic about the prospect of a psychedelic drug being used as a medical treatment.

While advocates point out that a key difference between pure MDMA used in a medical setting and street versions of ecstasy or Molly is that street versions are often mixed with other harmful drugs, MDMA itself is not without side effects.

In its purest form, MDMA can lead to nausea, chills, sweating, muscle cramping, and blurred vision. Overdose can also occur with symptoms including high blood pressure, faintness, panic attacks and in severe cases, loss of consciousness and seizures.

"I think it's a dangerous substance," Andrew Parrott, a psychology professor at Swansea University in Wales who spent years researching the drug's harmful effects, told the Washington Post.

He told the newspaper that he worries approval for treatment of PTSD could lead the public to believe MDMA is safe for recreational use.

MAPS notes that serious adverse events have been uncommon and non-life threatening in their studies.

 

[Culex]

As a veteran who does suffer PTSD, i'm all for it. Saying that this could open the door for people abusing it as recreational is stupid.

People don't abuse anti depressants because it's used for mood disorders.

 

[ramuh]

Woah. This is awesome. Got too many buddies suffering from PTSD.

 

[Andrew Korenchkin]

As a veteran who does suffer PTSD, i'm all for it. Saying that this could open the door for people abusing it as recreational is stupid.

People don't abuse anti depressants because it's used for mood disorders.

Don't forget Amphemtamine for ADHD as well.

 

[Andrew Korenchkin]

Woah. This is awesome. Got too many buddies suffering from PTSD.

Supposedly Psychedelics help as well.

 

[Skellig Gra]

Makes a lot of sense. Hopefully this can help people.

 

[okno]

This is AMAZING news!!

 

[Ceallach]

Oh shit, maybe mommy can get medical to slide her some mollys.

 

[Breads]

People have been saying this for decades. Nice that it is finally recognized.

 

[bulletbill10]

Don't forget Amphemtamine for ADHD as well.

Selling of prescription amphetamines is actually a sizable problems, especially around college campuses. We actually had someone break into our house and steal someone in my family's ADHD medication.

i don't think this means they shouldn't be used, but saying they aren't abused isn't entirely true.

 

[FUME5]

Good, now continue on with those LSD trials.

 

[Escape Goat]

Emotional crash sounds not good

 

[Andrew Korenchkin]

Selling of prescription amphetamines is actually a sizable problems, especially around college campuses. We actually had someone break into our house and steal someone in my family's ADHD medication.

i don't think this means they shouldn't be used, but saying they aren't abused isn't entirely true.

I don't disagree. But you can't forget how lifesaving they are, so let's focus on the positive.

But I have a feeling that it's going to be the same old song for MDMA, at least somewhat. It's easier to fake ADHD than PTSD.

 

[Ponn]

I'm all for them finding solutions to help those with PTSD and thinking out of the box. I just hope something like this isn't rushed out the door and gets thorough and proper testing. The "emotional crash" part of the drug can be problematic with PTSD patients and dangerous if not monitored. Mental health medications can be much more of a trial and error testing of what works and what doesn't so anything with serious side effects needs to be taken seriously.

 

[Trouble]

I'm all for it if it helps some people.

Emotional crash sounds not good

We had a friend of mine in college basically on suicide watch for a week after he did a shit ton of MDMA one weekend and had really bad after effects. He was pretty clearly broken for a while, it was weird and downright scary.

 

[Andrew Korenchkin]

I'm all for it if it helps some people.



We had a friend of mine in college basically on suicide watch for a week after he did a shit ton of MDMA one weekend and had really bad after effects. He was pretty clearly broken for a while, it was weird and downright scary.

Yeah, we need to be aware of the difference between recreation and therapeutic.

 

[theofficefan99]

As long as people don't abuse it and it ends up backfiring, I'm all for it.

Seriously though I've been on ADHD medication for about 9 or so months now and my life has improved by maybe 5000%. Does it suck that I have to rely on a drug to live? Yeah I guess. But I gotta do what I gotta do.

 

[kyser73]

Interesting that the article closes with that quote from Parrot - he was anti-MDMA for therapy before he started researching it!

Anyway this is amazing news for PTSD sufferers and the potential benefits FAR outweigh the risks - at its height in the 1990s ~2m people were estimated to be taking E over the weekend in the U.K. and MDMA itself has never been listed as a CoD, rather its secondary effects, such as overheating, often exacerbated by user ignorance, over hot club environments and so on.

I'm all for it if it helps some people.



We had a friend of mine in college basically on suicide watch for a week after he did a shit ton of MDMA one weekend and had really bad after effects. He was pretty clearly broken for a while, it was weird and downright scary.

So commonplace in fact that it's called Moody Monday/Tuesday. After caning E from Weds-Sunday at Glastonbury I felt like shit for about a week, but as I knew it was going to happen I made sure I was eating treptophan heavy foods, made sure I avoided watching the news etc.

 

[Bad_Boy]

Totally okay with this.

 

[cpp_is_king]

I always thought it was interesting that so many drugs have depression and suicidal thoughts or emotional crashes as side effects, but there's no drug that's the opposite - just straight uo makes you happy. If it's so easy to find drugs that increase negative emotions, why is it so hard to find drugs that amplify positive emotions?

 

[kyser73]

I always thought it was interesting that so many drugs have depression and suicidal thoughts or emotional crashes as side effects, but there's no drug that's the opposite - just straight uo makes you happy. If it's so easy to find drugs that increase negative emotions, why is it so hard to find drugs that amplify positive emotions?

MDMA and it's variants are SSRIs, (Selective Sertonin Reuptake Inhibitors, like Prozac) and your body only has a certain amount available at any one time. A 125mg MDMA dose is 2-6 hours of absolute animal bliss, especially when consumed with friends. But whatever goes up comes down.

 

[riotous]

Pretty sure this would involve being administered the drug while in a therapy session, not simply being prescribed molly.

 

[Andrew Korenchkin]

MDMA and it's variants are SSRIs, (Selective Sertonin Reuptake Inhibitors, like Prozac) and your body only has a certain amount available at any one time. A 125mg MDMA dose is 2-6 hours of absolute animal bliss, especially when consumed with friends. But whatever goes up comes down.

MDMA is a Amphemtamine substitute, and acts on much more than Serotonin.

 

[Volimar]

I'm all for it if it helps people suffering but you just know that if it ever does get FDA approval it'll be the new over prescribed thing.

 

[kyser73]

MDMA is a Amphemtamine substitute, and acts on much more than Serotonin.

Yes it also acts on dopamine & other related neurorecptors & transmitters, but it's primary effect is to stop the reuptake of serotonin, which is also the main reason for the depressive effects from over dosing and/or long term use.

 

[XMonkey]

I'm sure the doses in these clinical settings are lower than most people take recreationally. I find the bad comedowns are usually a result of just taking too much. It makes a lot of sense that low doses of MDMA combined with other therapy methods would be effective, glad this is moving forward.

 

[Andrew Korenchkin]

Yes it also acts on dopamine & other related neurorecptors & transmitters, but it's primary effect is to stop the reuptake of serotonin, which is also the main reason for the depressive effects from over dosing and/or long term use.

Oh.

 

[kyser73]

I'm sure the doses in these clinical settings are lower than most people take recreationally. I find the bad comedowns are usually a result of just taking too much. It makes a lot of sense that low doses of MDMA combined with other therapy methods would be effective, glad this is moving forward.

Yeah, a quick search seems to suggest 60mg with another 60mg 2-4 hours later, depending on the additional psychotherapy counselling, so about half a recreational dose.

It is worth noting that as with any drug-inclusive therapy, it should be accompanied by talking therapies as well.

 

[Dynomutt]

As long as it's used right. Whether MMJ, MDMA, LSD, Shrooms. All ok as long as they're used right.

 

[cdyhybrid]

I'm sure the doses in these clinical settings are lower than most people take recreationally. I find the bad comedowns are usually a result of just taking too much. It makes a lot of sense that low doses of MDMA combined with other therapy methods would be effective, glad this is moving forward.

Yep.

They're not going to be having cuddle puddles in the therapist's office :lol

 

[Tagyhag]

3 decades of lobbying?

It's amazing how our country hasn't just collapsed under the weight of how shit our entire government is.

 

[hey_monkey]

People have been saying this for decades. Nice that it is finally recognized.

Yeah, I remember reading about this when I was a damn teenager. I hate that it took so long.

 

[CarpeDeezNutz]

I'm of the small minority that liked the come down from rolling.

 

[Snowybreak]

As long as it's used right. Whether MMJ, MDMA, LSD, Shrooms. All ok as long as their used right.

Microdosing psilocybin has actually helped me subdue depressive episodes. Ground up a couple grams into a jar of super tasty organic honey and then put it in a dropper bottle. Three drops and you got a mild warmth and sense of positive well-being without the trippiness and hallucinations. Of course, those who might have a negative reaction from psychedelics should probably stay clear.

Also the comedown is not even half as bad as a normal shroom comedown. The positive feelings tend to stay around even after the warmth has left.

 

[Chmpocalypse]

This is fantastic news!

 

[kyser73]

I'm of the small minority that liked the come down from rolling.

Me too - morning after is fluffy as, especially with a lil bit of blow & greenery.

 

[Madame M]

Let's roll

 

[Hoo-doo]

Me too - morning after is fluffy as, especially with a lil bit of blow & greenery.

So the comedown is softened by using more drugs? Well I never!

 

[Foffy]

Emotional crash sounds not good

If that crash is what people call "ego death" I would say it's probably the greatest good a human can experience.

We are often shackled by our accumulated self, and next to meditation, psychotropics force one to face this illusion in experience, usually with the feeling of "I" dying.

People who live fully are only able to do so if they die before they die, primarily for this reason.

 

[ChainedMaster]

As a veteran who does suffer PTSD, i'm all for it. Saying that this could open the door for people abusing it as recreational is stupid.

People don't abuse anti depressants because it's used for mood disorders.

Anti-depressants have questionable efficacy. Also, they're not drugs of abuse like MDMA is. I'm all for medicinal MDMA, but this isn't a very good comparison.

 

[kyser73]

So the comedown is softened by using more drugs? Well I never!

Heh, it's fluffy whatever, the additionals just keep the party going at a lower ebb

If that crash is what people call "ego death" I would say it's probably the greatest good a human can experience.

We are often shackled by our accumulated self, and next to meditation, psychotropics force one to face this illusion in experience, usually with the feeling of "I" dying.

People who live fully are only able to do so if they die before they die, primarily for this reason.

'Ego death' happens as you go up on mushies/acid.

 

[Zeus Molecules]

Emotional crash sounds not good

You burn through Dopamine on MDMA something fierce. It actually leads to some depression while your body builds it back up. MDMB could be a better alternative cause it releases less Dopamine but without the Dopamine release you won't roll and I think that is the point of the therapy suggestion.

 

[Frostinferno]

You burn through Dopamine on MDMA something fierce. It actually leads to some depression while your body builds it back up. MDMB could be a better alternative cause it releases less Dopamine but without the Dopamine release you won't roll and I think that is the point of the therapy suggestion.

Serotonin. It relies way less on dopamine. And the comedown is a non-issue unless you're going well over 100mg.

 

[Andrew Korenchkin]

Serotonin. It relies way less on dopamine. And the comedown is a non-issue unless you're going well over 100mg.

On that note, would MDMA be a good anti depressant too?