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Offline13.step
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Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA
    #11226509 - 10/11/09 02:54 PM (8 years, 2 months ago)

9. Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA

On September 16, the FDA permitted us to proceed with our clinical investigation, "A Phase I Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA when Administered to Healthy Volunteers," also referred to as our MDMA/PTSD therapist training protocol.

Through extensive discussions and cooperation with the FDA, the protocol meets two goals at once. On the one hand, it is designed as a Phase 1 randomized, placebo-controlled, double-blind study of the psychological effects of MDMA on healthy volunteers. On the other hand, enrollment is limited to subjects who are participating in our MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) therapist training program. The final draft of the protocol meets both the FDA’s goals and MAPS’ goals. Now that we have the FDA’s "may proceed" letter, we will be seeking approval from an Institutional Review Board (IRB).

We will be measuring the psychological effects of MDMA on "healthy normals" as contrasted with our international series of Phase 2 pilot studies evaluating MDMA-assisted psychotherapy in people who have treatment-resistant posttraumatic stress disorder (PTSD). We will employ some psychological measures that have not yet been used in an MDMA research project as well as some that we have used before. The psychological measures include measuring mood with the Profile of Mood States, personality with the Neuroticism-Extroversion-Openness (NEO) Inventory, interpersonal closeness with a nonverbal (visual analog) self-report measure, psychological symptoms with the Brief Symptom Inventory (BSI), and suicidality with the Columbia Suicide Severity Rating Scale (C-SSRS). As a crossover study, subjects will get placebo on one occasion and MDMA on the other.

The FDA’s "may proceed’’ letter marks a major turning point for MAPS. We now have the ability to offer one full-dose MDMA-assisted psychotherapy session to therapists who are preparing to conduct Phase 2 and Phase 3 MDMA/PTSD studies for MAPS. During these studies we will be gathering information about the psychological dynamics of MDMA-assisted psychotherapy. We believe that this new protocol substantially increases the chances that we will successfully conduct the next step in our mission: a Phase 3 multi-site pilot study with 20-30 co-therapist teams.

http://www.maps.org/news/#9


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OfflineCollegeGuy
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Registered: 11/30/07
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: 13.step]
    #11226762 - 10/11/09 03:57 PM (8 years, 2 months ago)

wouldn't it pretty obvious if you got the placebo? lol just kidding I know thats no how it works.

This is cool though maybe we can get some real information.


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OfflineNature Boy
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: 13.step]
    #11226781 - 10/11/09 04:02 PM (8 years, 2 months ago)

That's outstanding news.  By all accounts, MDMA does wonders for post-traumatic stress syndrome and other ailments.

N.B.


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OfflineIslandminded
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: CollegeGuy]
    #11226804 - 10/11/09 04:08 PM (8 years, 2 months ago)

Quote:

CollegeGuy said:
wouldn't it pretty obvious if you got the placebo?




They probably use an active placebo, Ritalin or something similar.


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Invisiblepwnasaurus
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: Islandminded]
    #11227119 - 10/11/09 04:58 PM (8 years, 2 months ago)

I want in on this study!  100% pure medical grade MDMA - hell yes!


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Offlinesilosighbin
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: pwnasaurus]
    #11227735 - 10/11/09 06:34 PM (8 years, 2 months ago)

Quote:

pwnasaurus said:
I want in on this study!  100% pure medical grade MDMA - hell yes!




fuck yeah


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Offlineneopet nub
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: Islandminded]
    #11228091 - 10/11/09 07:32 PM (8 years, 2 months ago)

Quote:

Islandminded said:
Quote:

CollegeGuy said:
wouldn't it pretty obvious if you got the placebo?




They probably use an active placebo, Ritalin or something similar.




They might use adrenaline. They want a placebo with no bad side effects


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Offlineblunt master
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: neopet nub]
    #11228222 - 10/11/09 07:54 PM (8 years, 2 months ago)

:thumbup:


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Offlinebriant230
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: blunt master]
    #11228255 - 10/11/09 07:59 PM (8 years, 2 months ago)

umm doesn't an active placebo make it not a placebo at all?


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Invisiblepwnasaurus
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: briant230]
    #11228436 - 10/11/09 08:24 PM (8 years, 2 months ago)

Placebo: an innocuous or inert medication; given as a pacifier or to the control group in experiments on the efficacy of a drug

By that definition I would yes, not a placebo at that point.


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OfflineCollegeGuy
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: Islandminded]
    #11228562 - 10/11/09 08:42 PM (8 years, 2 months ago)

Quote:

Islandminded said:
Quote:

CollegeGuy said:
wouldn't it pretty obvious if you got the placebo?




They probably use an active placebo, Ritalin or something similar.





I was only the pointing out a funny...

is it possible to acquire adrenaline?


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All posts from this account do not contain any factual or real events only ones that could happen.


Edited by CollegeGuy (10/11/09 08:44 PM)


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Offlinebluecurry
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: pwnasaurus]
    #11229259 - 10/11/09 10:20 PM (8 years, 2 months ago)

Quote:

pwnasaurus said:
Placebo: an innocuous or inert medication; given as a pacifier or to the control group in experiments on the efficacy of a drug

By that definition I would yes, not a placebo at that point.




http://bipolar.about.com/od/medications/f/faq_placebo.htm

Quote:

More recently, drug companies have begun to produce "active placebos." These pills, unlike the sugar or starch pills of old, contain ingredients that mimic the common side effects of the drug under study.




times, they be changing. However it is good that, when people think placebo, they think inert substance. I would imagine that believing a placebo is inert, would potentiate the psychological impact of an active placebo.


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InvisibleCognitive_Shift
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: bluecurry]
    #11229298 - 10/11/09 10:28 PM (8 years, 2 months ago)

:thumbup:

MDMA makes me see everything in the most positive light.  I can see where this could be helping people.


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InvisibleDutchie3k
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Registered: 12/16/08
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: Cognitive_Shift]
    #11229544 - 10/11/09 11:09 PM (8 years, 2 months ago)

In fact many, MANY leading psychologists, therapists, psychiatrists, counselors etc. realized the absolutely immense potential of MDMA and related substances (See: PIHKAL) in the 1960's and 70's, before the VAST majority of these compounds became illegal.  There was a great deal of "underground" testing by mental health professionals, doctors, pharmacologists into the efficacy of the drugs, and overall they were found to be a miracle cure in terms of overcoming a mental disorder.  Many psychologists/psychiatrists conducted therapy sessions with willing patients using MDMA, TMA etc. and experienced overwhelming success.
  However, the government was quick to A)ban any and all human trials (thus illegitimizing any research conducted) and subsequently B) ban the substances.  It only took 30 years for somebody to change their hillbilly mind :laugh:


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Offlineicanttype
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Registered: 11/18/07
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Re: Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA [Re: silosighbin]
    #11234549 - 10/12/09 07:23 PM (8 years, 1 month ago)

Quote:

silosighbin said:
Quote:

pwnasaurus said:
I want in on this study!  100% pure medical grade MDMA - hell yes!




fuck yeah



:thumbup:


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GGTBod - "Sounds great, get trippin get naked and get animalistic make her laugh and piss all over you, i see no problems here :blush:"


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