FDA Grants Request for End of Phase 2 Meeting This November

Zendo Project psychedelic harm reduction service assists 180 attendees at Symbiosis Festival

October 5, 2016

Dear friends and supporters,

This week, we reached an important milestone in our work to make MDMA-assisted psychotherapy an approved treatment for posttraumatic stress disorder (PTSD). On October 3, the U.S. Food and Drug Administration (FDA) granted our request for an End of Phase 2 meeting to agree on the design of our upcoming Phase 3 trials, the final stage of research required to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD. The meeting is scheduled for November 29, and Phase 3 trials expected to begin early next year.

MAPS' Phase 3 clinical trials will require many new researchers trained in the principles and practice of MDMA-assisted psychotherapy for PTSD. Last month, 31 therapists in training to be Phase 3 researchers participated in the MAPS Therapist Training Program (pictured above). Additional participants were also treated in our ongoing therapist training study in preparation for Phase 3.

In the October 2016 edition of the MAPS Email Newsletter, you'll also learn:

The first pair of participants receive their second experimental treatment in our new study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD

in our new study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD The 11th participant is treated in our ongoing trial of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness

in our ongoing trial of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness The 12th participant is enrolled in our ongoing study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum

in our ongoing study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum Participant screening begins at the Phoenix, Ariz., site of our upcoming trial of smoked marijuana for symptoms of PTSD in U.S. veterans

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Do you want to present your research at Psychedelic Science 2017? Abstracts are due November 1. Also, get 15% off registration for Psychedelic Science 2017 until November 15.

There have never been so many opportunities for scientific research into the therapeutic benefits of psychedelics and marijuana-and that means your support is more important than ever. Find out how you can help.

$200,000 estimated study cost $165,000 raised $35,000 still needed Donate Now help fund more research Conjoint Therapy for PTSD: First Pair of Participants Receive Second Treatment On August 23, 2016, the first pair of participants received their second experimental treatment in our new study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD in Charleston, South Carolina. Final outcome measures for this pair (dyad) will be collected during the one-month follow-up taking place on October 9, 2016. The study will enroll 10 dyads, with one participant diagnosed with PTSD and one concerned significant other who does not have PTSD but does experience psychosocial distress. The primary goal of this study is to develop a combined method of MDMA with CBCT for PTSD. MDMA will be administered to both participants to help facilitate communication and connection between participants and therapists. We are currently screening additional local participants for this study. Learn more...

$200,000 estimated study cost $165,000 raised $35,000 still needed Donate Now help fund more research Boulder: 19th Participant Completes Long-Term Follow-Up Interview On October 3, 2016, the 19th participant completed their long-term (12-month) follow-up interview in our Phase 2 study of MDMA-assisted psychotherapy for 23 subjects with chronic, treatment-resistant PTSD in Boulder, Colorado. Long-term follow-up data will provide additional information to guide the design of our upcoming Phase 3 trials. The final results are being prepared for publication, which is expected in 2017. Learn more...

$802,000 estimated study cost $802,000 raised Funding

Complete Donate Now help fund more research MDMA-Assisted Psychotherapy for Anxiety Associated with Life-Threatening Illness Marin: 11th Participant Treated; 12th Participant Enrolled On September 15, 2016, the 11th participant was treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif. On August 26, 2016, the 12th participant was officially enrolled. Led by Principal Investigator Phil Wolfson, M.D., with co-therapist Julane Andries, LMFT, this study is gathering preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety in 18 subjects diagnosed with a life-threatening illness. We are currently screening additional participants for this study. Learn more...