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MDMA approved by FDA for Phase 3 trials for PTSD treatment

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cdyhybrid

Member
https://www.theguardian.com/science/2016/dec/01/fda-mdma-ptsd-final-trials

The US Food and Drug Administration (FDA) has given the green light to phase three trials of MDMA to treat post-traumatic stress disorder, the final phase of validation required to turn the party drug into a legal medicine.

The treatment involves giving patients the drug just three times – once a month – during long talking therapy sessions, interspersed with weekly sessions without the drug. Early trials of the drug, currently listed as a schedule 1 substance by the Drug Enforcement Administration along with heroin and cocaine, have shown encouraging results for patients with treatment-resistant PTSD.

“Moving from phase two to phase three shows we have strong scientific reason to believe that MDMA is an effective treatment for PTSD in therapy. The fact the FDA is ready to move forward with phase three signals that they agree,” said Brad Burge, from the Multidisciplinary Association for Psychedelic Studies (Maps), a not-for-profit based in Santa Cruz, California, that has spearheaded efforts to turn MDMA into a medicine.

James “CJ” Hardin suffered with the disorder for years following his three tours in Iraq and Afghanistan. He had nightmares and insomnia and loud sounds or flashes of light could send him into a state of anxiety. He was given psychotherapy and prescribed antidepressants and anti-anxiety tablets, but nothing worked.

That is, until he he enrolled in one of Maps’ trials of MDMA-assisted psychotherapy. Hardin experienced a dramatic turnaround in his mental health within three months, and no longer has PTSD.

“It has allowed me to be a productive member of society and given me new hope,” he said.

The meat of the article:

One South Carolina study involved 20 patients, mostly victims of sexual abuse, who had suffered from PTSD for more than 19 years. It was a placebo-controlled study, so all patients were given the same therapy, but only some were given the MDMA; 83% of those given the MDMA no longer met the criteria for PTSD following treatment, compared with 25% of those who were not given the drug. The results have held for several years.

Maps has funded a total of six phase two studies of the drug, in which 136 patients have undergone MDMA-assisted therapy. Phase three trials require bigger groups of patients, at least 230 people, across different countries.

Maps submitted data from its phase two trials along with plans for phase three to the FDA a month ago. On 29 November, the FDA gave the final phase of trials the go-ahead, subject to further clarification on a few technical details, including how to ensure double blinding with a drug whose effects are so dramatic. The recruitment of patients is scheduled to start in June 2017.

If the ensuing studies provide positive results, MDMA could be approved for prescription use by 2021. Around 50% of drugs fail at this stage, however.
 

Geist-

Member
This sounds really good. PTSD is such a crippling problem for so many people, and MDMA sounds like it has real results.
 
83% of those given the MDMA no longer met the criteria for PTSD following treatment, compared with 25% of those who were not given the drug. The results have held for several years.

Jesus. Is it safe to say that if not for the stigma of the drugs primarily recreational use we'd have gotten to this point a long time ago and a lot of people could've been helped by now? Cuz that's fucking amazing.
 

Suikoguy

I whinny my fervor lowly, for his length is not as great as those of the Hylian war stallions
Jesus. Is it safe to say that if not for the stigma of the drugs primarily recreational use we'd have gotten to this point a long time ago and a lot of people could've been helped by now? Cuz that's fucking amazing.

We so badly need fact based drug policy.
 

GhostBed

Member
Wow. That's fucking incredible. And fucking sad that Marijuana is still a schedule 1 drug. (Two different organizations but still.)
 

Trojita

Rapid Response Threadmaker
I wonder what exactly causes the reversal. That's a huge percentage difference too.
 

A Fish Aficionado

I am going to make it through this year if it kills me
Jesus. Is it safe to say that if not for the stigma of the drugs primarily recreational use we'd have gotten to this point a long time ago and a lot of people could've been helped by now? Cuz that's fucking amazing.
Yup. Let's not forget Sandoz labs was manufacturing most of the LSD for psychiatry research. Psychedelic drugs are certainly very good research drugs.

The politics of they day fucked the whole trajectory of psychiatry. We probably would have better novel drugs for depression and anxiety, and so many other drugs instead of stop gaps such as SSRIs.
 

Kallor

Member
Some of these drugs are just amazingly helpful to people who can't seem to get help from anything else. Psilocybin is another one I guarantee goes on to help millions of people in the legal market one of these days.
 

krrrt

Member
Finally the world is catching on to the fact that being fun to use recreationally does not imply that some drugs have a lot of therapeutic value.
 

Stasis

Member
Somehow Trump or his elected cabinet will fuck all of this though, right? Along with the legalization of marijuana.

I hate to be that guy but I can't help thinking anything peogressive will be targeted.

Maybe Canada can carry the torch until you get them the fuck out.
 
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