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skatealex2
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Registered: 07/04/08
Posts: 18,699
Last seen: 5 months, 13 days
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FDA Approves MDMA Study for PTSD- War Veterans
#11999675 - 02/10/10 12:33 AM (14 years, 1 month ago) |
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"The FDA Approves Another MAPS Study! February 9, 2010
Dear MAPS Members and Supporters,
The good news just keeps on pouring in! On February 1, the FDA sent us a “may proceed” letter for our study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) in veterans of war. The design of this study is our most sophisticated and complicated to date. This may become the design for the large-scale, multi-site MDMA/PTSD Phase 3 studies that FDA requires to prove safety and efficacy prior to approval for use as a prescription medication.
This study will evaluate whether veterans with war-related PTSD respond similarly to subjects in our initial MDMA/PTSD study. Those subjects were primarily women with PTSD as a result of sexual abuse, rape, or violent crime (although two subjects were male veterans with war-related PTSD). We will enroll sixteen veterans, roughly equal numbers of men and women. We will test three different doses of MDMA to evaluate which doses can be used to effectively produce a double-blind study in which the subjects and therapists make a substantial number of incorrect guesses about which dose was randomly administered. In our pilot study, the therapists always guessed correctly, and the subjects almost always guessed correctly, as to whether an inactive placebo or a full-dose of MDMA was administered. This new protocol also allows enrollment of subjects with Hepatitis C and controlled hypertension – subjects with either condition were excluded in the pilot study. You can read more about the study on our MDMA page, where all the pertinent documents are available for view.
In a reflection of how skilled the MAPS clinical research team has become at designing scientific protocols, the FDA approved the new protocol without asking for any changes. This is a remarkable accomplishment and a first for MAPS.
We are now seeking approval for our MDMA/PTSD study in veterans from the Institutional Review Board (IRB), which we anticipate will take about 1 month. If all goes well, the study can begin enrolling subjects this spring.
This newest study is projected to cost MAPS approximately $500,000. We are working diligently to secure funding from large foundations, which due to the controversial nature of MDMA have not yet funded any of our research. For the time being, we are counting on your support to fund our groundbreaking studies. Please donate today to ensure that this study can be completed. To sweeten the offer we have a great gift of the month from Ram Dass and Ralph Metzner below.
Sincerely,
Randolph Hencken, M.A. Director of Communication and Marketing, MAPS Conference Organizer "
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sui
I love you.
Registered: 08/20/04
Posts: 32,460
Loc: Cali, Contra Costa Co.
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: skatealex2]
#11999682 - 02/10/10 12:34 AM (14 years, 1 month ago) |
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-------------------- "There is never a wrong note, bend it." Jimi Hendrix
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LuNaTiX
Quarterback
Registered: 07/28/03
Posts: 5,142
Last seen: 5 months, 4 days
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: skatealex2]
#11999698 - 02/10/10 12:38 AM (14 years, 1 month ago) |
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Niceee
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DeadHearts
Registered: 07/17/09
Posts: 21,827
Loc: MICHIGAN
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: LuNaTiX]
#11999718 - 02/10/10 12:41 AM (14 years, 1 month ago) |
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NetDiver
Wandering Mindfuck
Registered: 08/24/09
Posts: 6,024
Loc: Everywhere and Nowhere
Last seen: 1 year, 8 months
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: DeadHearts]
#11999773 - 02/10/10 12:54 AM (14 years, 1 month ago) |
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SillyBilly
Professional
Registered: 03/05/09
Posts: 3,634
Loc: Californi-eh
Last seen: 8 years, 2 months
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: NetDiver]
#11999781 - 02/10/10 12:56 AM (14 years, 1 month ago) |
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I've never done mdma. I'm such a drug virgin.
-------------------- By the livin' Gawd that made you, You're a better man than I am, Gunga Din
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skatealex2
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Registered: 07/04/08
Posts: 18,699
Last seen: 5 months, 13 days
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: SillyBilly]
#11999791 - 02/10/10 12:58 AM (14 years, 1 month ago) |
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Quote:
SillyBilly said: I've never done mdma. I'm such a drug virgin.
never done mdma ether. I'm not so big on uppers... but i might end up trying it at some point .. Love lsd though
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SillyBilly
Professional
Registered: 03/05/09
Posts: 3,634
Loc: Californi-eh
Last seen: 8 years, 2 months
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: skatealex2]
#11999809 - 02/10/10 01:03 AM (14 years, 1 month ago) |
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I've never been able to get real acid. I think the one time I sort of tripped off of some it was some rc or just real weak. I've told multiple people to keep an eye out for me. These articles where they decide to use recreational drugs for medicinal uses is real good news.
-------------------- By the livin' Gawd that made you, You're a better man than I am, Gunga Din
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thatkid
New age hippie
Registered: 11/21/09
Posts: 16
Last seen: 9 years, 7 months
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: skatealex2]
#11999811 - 02/10/10 01:03 AM (14 years, 1 month ago) |
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it's about time we started experimenting with drugs for medicinal values, especially one with such positive effects as mdma. i love rolling
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skatealex2
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Registered: 07/04/08
Posts: 18,699
Last seen: 5 months, 13 days
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Re: FDA Approves MDMA Study for PTSD- War Veterans [Re: thatkid]
#12001537 - 02/10/10 11:10 AM (14 years, 1 month ago) |
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Quote:
thatkid said: it's about time we started experimenting with drugs for medicinal values, especially one with such positive effects as mdma. i love rolling
word. lsd, mushrooms, mdma and marijuana should all be studied extensively
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