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Invisibletdubz
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Registered: 02/26/12
Posts: 5,586
The Government Gets One Step Closer to Approving MDMA to Treat PTSD
    #23883674 - 12/01/16 05:16 AM (7 years, 1 month ago)

https://motherboard.vice.com/read/the-government-gets-one-step-closer-to-approving-mdma-to-treat-ptsd

Few weeks go by when we don’t hear of the various possibilities of using psychedelics as treatment—whether it's ayahuasca or LSD. Now the government has brought us one step closer to legalizing psychedelics as medicine.

On Tuesday, the Multidisciplinary Association for Psychedelic Studies (MAPS) received approval from the FDA to go forward on a study looking into MDMA, the main chemical in ecstasy, for the treatment of PTSD. Having already completed the first two necessary phases of FDA-approved research, the up and coming third and final phase of the study will be the last major step before MDMA can become available to qualifying patients. MAPS’ goal is to have MDMA approved by the FDA as a legal treatment for PTSD by 2021.

Brad Burge, MAPS director of communications and marketing, explained to Motherboard how MDMA works to reduce PTSD symptoms: It enhances activity in the prefrontal cortex, enhancing memory and awareness, it reduces activity in the amygdala, the part of the brain that regulates fear and hyperarousal, and it causes the release of hormones, including oxytocin and prolactin, increasing trust and empathy between the participant and the therapists. By reducing fear through the amygdala, a mass of grey matter in the brain that impacts emotions, MDMA allows participants to revisit and reprocess trauma, adds Natalie Ginsberg, policy and advocacy manager at MAPS.

The third phase of MAPS' MDMA for PTSD research will begin next year, probably by June 2017, and will last three to four years, Burge said. They'll enroll at least 230 participants, or as many as 400, depending on whether they do one or two Phase 3 trials, he said. The greatest challenge, he added, will be funding, since MAPS will need to raise about $20 million to complete these trials over the next four years. "Phase 3 is much larger than Phase 2 trials, and is intended to obtain data on treatment effectiveness, as well as safety in a larger population than was seen in Phase 2 trials."

The Phase 2 trials, lasting from 2000 through 2016, involved 107 participants. In past research, participants with PTSD included veterans, survivors of sexual assault, police and firefighters. MAPS' Phase 2 trial, 130 patients were treated over the course of six studies. On average, patients had suffered from PTSD for about 17 years. At the end of the study, two thirds of patients no longer qualified for having PTSD, while after three doses of MDMA in assisted psychotherapy, their symptoms diminished by an average of 56 percent.

According to PTSD researcher Dr. Charles Marmar, head of psychiatry at New York University's Langone School of Medicine, who is not involved in MAPS' study, even the best therapies currently available don't help 30 to 40 percent of patients. "So we need more options," he told the New York Times. And Rachel Hope, a patient who underwent a 2012 MDMA study to treat trauma from childhood sex abuse, told CNN it allowed her to "rewire" her brain.

That said, the experience of therapy can be hard. "It's painful, Mithoefer told Motherboard in the past. "A few people on the first day have said they don't know why it's called ecstasy."


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InvisibleRepertoire89
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Registered: 11/15/12
Posts: 21,773
Re: The Government Gets One Step Closer to Approving MDMA to Treat PTSD [Re: tdubz]
    #23887684 - 12/02/16 01:48 PM (7 years, 1 month ago)

Great news, i know what they mean about the psychological difficulty with mdma, its usually an immense ordeal for me but very therapeutic

MDMA is strong medicine


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Invisiblebadchad
Mad Scientist

Registered: 03/02/05
Posts: 13,372
Re: The Government Gets One Step Closer to Approving MDMA to Treat PTSD [Re: Repertoire89]
    #23887710 - 12/02/16 01:58 PM (7 years, 1 month ago)

Closer, albeit a very small step.  Phase 3 is where its at.


--------------------
...the whole experience is (and is as) a profound piece of knowledge.  It is an indellible experience; it is forever known.  I have known myself in a way I doubt I would have ever occurred except as it did.

Smith, P.  Bull. Menninger Clinic (1959) 23:20-27; p. 27.

...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

Osmond, H.  Annals, NY Acad Science (1957) 66:418-434; p.436


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InvisibleShroomerInTheRye
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Registered: 01/12/12
Posts: 13,036
Loc: Themyscira Flag
Re: The Government Gets One Step Closer to Approving MDMA to Treat PTSD [Re: badchad]
    #23888516 - 12/02/16 06:41 PM (7 years, 1 month ago)

Shout out to MAPS for making that happen.  I really hope that they can get the $20M they need. 

Maybe I'm missing something about pharmaceutical companies.  I get that they don't really want to deal with psychedelics because the patents have expired and blah blah blah.  Can't they still make a product and make money with that product using these compounds?


--------------------
:nyan: <-- Clicky Clicky


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OfflineCLIT
Stranger
Registered: 01/23/12
Posts: 2,758
Last seen: 1 year, 11 days
Re: The Government Gets One Step Closer to Approving MDMA to Treat PTSD [Re: ShroomerInTheRye]
    #23889612 - 12/03/16 02:54 AM (7 years, 1 month ago)

Patents to MDMA? I would think only certain companies are allowed to make a "generic" version vs. "non-generic", otherwise it floods the market. I think it has to do with insurance as well, which ones covers what types of meds, will apply (generic vs. non generic, etc.). There are regulations as to who makes what otherwise everyone would sell the best selling generic ever and it will only over saturate the market.

Question is, when can we get to phase 3 being approved?


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Invisiblebadchad
Mad Scientist

Registered: 03/02/05
Posts: 13,372
Re: The Government Gets One Step Closer to Approving MDMA to Treat PTSD [Re: ShroomerInTheRye]
    #23889889 - 12/03/16 08:08 AM (7 years, 1 month ago)

Quote:

ShroomerInTheRye said:


Maybe I'm missing something about pharmaceutical companies.  I get that they don't really want to deal with psychedelics because the patents have expired and blah blah blah.  Can't they still make a product and make money with that product using these compounds?




They can get "exclusivity" which is arguably, more valuable than a patent. For a period of time, they will be the only ones that can sell MDMA for PTSD. After that time period, generics can enter the market.

Due to the lengthy development times, patents are usually expired by the time a drug gets to market.


--------------------
...the whole experience is (and is as) a profound piece of knowledge.  It is an indellible experience; it is forever known.  I have known myself in a way I doubt I would have ever occurred except as it did.

Smith, P.  Bull. Menninger Clinic (1959) 23:20-27; p. 27.

...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.

Osmond, H.  Annals, NY Acad Science (1957) 66:418-434; p.436


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