The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA (the main compound found in ecstasy) for the treatment of posttraumatic stress disorder (PTSD).
The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.
MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct.
MDMA (ecstasy) has gained popularity in recent years, though many avoid it due to its chemical nature and its illegal status. Along comes Katy!
Limitless Life has developed and released an entirely legal, safe and all-natural alternative to MDMA. Katy is “the world’s most powerful, all natural, plant-based experience enhancing supplement.” It’s dopamine-, serotonin- and GABA-stimulating, but requires no prescription and comes without risk.
Developed by biohacker, entrepreneur Mark Effinger and human potential expert Dolan Ramsay, Katy promises a “euphoric, blissed out, sensory hightened, love filled experience”; it’s also 98% organic!
Katy is made up of Kava Kava, omniracetam, EGCG, 5-HTP, guarana extract, grape seed extract, theobromine and curcumin. These are the same ingredients used for brain-enhancing nutrients, neuro stimulants and adaptogens (used to improve overall wellness).
Over at EDM.com, they recently gave Katy a try for themselves. All five who used it reported feeling “energized and heightened, though we struggled to find the exact stimulants to compare it to – red bull, coffee, a 5-Hour Energy.” What they could all agree on; “this was no placebo effect, and we all felt “buzzed.” Some of us started to feel a rise in body temperature, feeling a bit warm and clammy. What started as an energy boost started to feel more electric, like a light euphoria was setting in. We felt the need to drink water.”
In general, “it was a very positive experience to feel energized and heightened physically and mentally while not having to worry about breaking the law or chemically testing to make sure what we were ingesting was actually safe. There were no moments that were too intense nor any drop-offs or complete crashes. We gave the peace of mind that comes with Katy a 10 out of 10. 4 out of 5 of us said we’d do it again.”
The Food and Drug Administration has given approval to Phase 3 clinical trials of MDMA (ecstasy) for the treatment of post traumatic stress disorder (PTSD). This is the final step before the potential approval of ecstasy as a prescription drug.
The move comes after several successful Phase 2 studies of ecstasy, which included 130 PTSD patients. These were conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS). The new research will include at least 230 participants and will also be conducted by MAPS.
The Drug Enforcement Adminsitration (DEA) has approved a study of MDMA (pure ecstasy) for the treatment of anxiety associated with terminal illnesses.
“On March 13, 2015, the U.S. Drug Enforcement Administration approved the Schedule I license for Phil Wolfson, M.D., the Principal Investigator for our upcoming study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness”, the Multidisciplinary Association for Psychedelic Studies (MAPS) said in a recent newsletter. “This was the final regulatory approval needed for the study, which was approved by an Institutional Review Board (IRB) on September 16, 2014, the Research Advisory Panel of California (RAPC) on December 15, 2014, and by the U.S. Food and Drug Administration on November 13, 2014.”