FDA Receives Protocol for Phase 3 Study of MDMA-Assisted Therapy for PTSD
First participant enrolled in first-ever trial of marijuana for chronic PTSD in veterans
With just 63 days left until Psychedelic Science 2017, we’re getting increasingly excited to welcome you and over 1,000 other supporters to Oakland, Calif., to this six-day gathering.
We’re making great strides with our clinical research program. The U.S. Food and Drug Administration (FDA) has confirmed their receipt of our protocol submission for our Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), and the first participant was officially treated in our ongoing Phase 2 trial of smoked marijuana for PTSD in 76 U.S. veterans.
In the February 2017 edition of the MAPS Email Newsletter, you’ll also learn:
- Tickets for Psychedelic Science 2017 are still available—register now!
- Three more participants complete 12-month follow-up interviews in our Colorado and Israel studies of MDMA-assisted psychotherapy for PTSD
- Our ongoing Phase 1 MDMA therapist training study enrolls two more participants
- Adult military veterans who experienced trauma while in military service are needed for a study
- The second pair of participants receives treatment in our ongoing study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD
Stay connected by following MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
Keep an eye out for special announcements about Psychedelic Science 2017—you won’t to miss this historic event.
Always upwards,
Brad Burge
MAPS Director of Communications and Marketing
P.S. Watch and share the all-new video to learn what’s in store at Psychedelic Science 2017!
Contents
Treating PTSD with MDMA-Assisted Therapy
1 FDA Receives Protocol for Phase 3 Trial of MDMA-Assisted Therapy for PTSD
2 Boulder: Final Participant Completes 12-Month Follow-Up
3 Israel: Three Participants Complete 12-Month Follow-Up
4 Therapist Training Study: 22nd and 23rd Participants Enrolled in Colorado
5 Conjoint Therapy for PTSD: Second Pair of Participants Receive Treatment
6 MDMA Therapy Training Program: Preparing for Phase 3
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
7 Marin: 15th and 16th Participants Treated; 17th Participant Enrolled
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
8 Psychedelic Science and Neurodiversity by Alicia Danforth, Ph.D.
Medical Marijuana
10 Are You a U.S. Military Veteran with PTSD?
Ayahuasca Research
Psychedelic Harm Reduction
12 Zendo Project: Volunteer at Lightning in a Bottle 2017
Support MAPS
13 January Giving Report: New Year, Big Goals
Media
14 The Today Show, PBS NewsHour, WebMD, and more…
MAPS Store
15 MAPS Insulated Klean Kanteen Bottle
16 The Ketamine Papers: Science, Therapy, and Transformation
Events
17 Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
18 “A Good Trip” Tour with Comedian Shane Mauss: February 13 – May 7, 2017, United States
19 Women and Cannabis Salon: March 4-5, 2017, San Francisco Bay Area, CA
20 Students for a Sensible Drug Policy (SSDP) Annual Conference: March 24-26, 2017, Portland, OR
21 International Drug Policy Reform Conference: October 11-14, 2017, Atlanta, GA
Register now for Psychedelic Science 2017.
Treating PTSD with MDMA-Assisted Therapy
FDA Receives Protocol for Phase 3 Trial of MDMA-Assisted Therapy for PTSD
Boulder: Final Participant Completes 12-Month Follow-Up
On February 1, 2017, the final participant completed their 12-month follow-up interview in our Phase 2 study of MDMA-assisted psychotherapy in 23 subjects with chronic PTSD in Boulder, Colorado led by Principal Investigator Marcela Ot’alora, M.A., L.P.C. All treatment sessions and long-term follow-up interviews for this study have now been completed. These 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…
Israel: Three Participants Complete 12-Month Follow-Up
On February 2 and February 7, 2017, the eighth and ninth of 10 participants completed their 12-month follow-up interviews in our Israeli Phase 2 study of MDMA-assisted psychotherapy for PTSD. The seventh participant completed their 12-month follow-up interview on December 8, 2016. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study has treated 10 subjects with chronic, treatment-resistant PTSD from any cause. Learn more…
Therapist Training Study: 22nd and 23rd Participants Enrolled in Colorado
On January 11 and January 25, 2017, the 22nd and 23rd participants were enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. The new participants were enrolled at the Boulder, Colorado, study site led by Principal Investigator Marcela Ot’alora, M.A., L.P.C. Michael Mithoefer, M.D., and Ann Mithoefer, B.S.N., are serving as Principal Investigators at the site in Charleston, South Carolina. Enrollment in this study is limited by invitation only to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD. This study has currently enrolled 23 out of 100 participants across the study sites in Colorado and South Carolina. Learn more…
| $429,000 estimated study cost | $160,000 raised | $269,000 still needed |
Donate Now |
Conjoint Therapy for PTSD: Second Pair of Participants Receive Treatment
On January 30, 2017, the second pair of participants received their first experimental treatment in our new study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD in Charleston, South Carolina. This pair (dyad) was officially enrolled on January 28, 2017. 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. Learn more…
| $235,000 estimated study cost | $165,000 raised | $70,000 still needed |
Donate Now |
MDMA Therapy Training Program: Preparing for Phase 3
From January 15-21, 2017, 44 trainees gathered in Stony Point, New York, to participate in Part B of the MDMA Therapy Training Program. The five-part training program is currently preparing therapy teams for upcoming MAPS-sponsored Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. Part B of the program is a week-long training led by MAPS-sponsored researchers Michae
l Mithoefer, M.D., Annie Mithoefer, B.S.N., and Marcela Ot’alora, M.A., L.P.C. The program is a prerequisite for anyone working on a therapy team in a MAPS-sponsored Phase 3 trial. All Phase 3 researchers will also complete Parts C-E of the training program, which include an external workshop, a second week-long training, a final evaluation, and clinical supervision. At this point, the training program is not accepting applications, however you can sign up to receive updates when future training opportunities become available. Sign up and learn more…
MAPS Bulletin Winter 2016: Vol. 26 No. 3 Annual Report
Art by Michael Divine
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: 15th and 16th Participants Treated; 17th Participant Enrolled
On January 19 and January 23, 2017, the 15th and 16th of 18 participants were treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif. The 17th participant was officially enrolled on January 30. Led by Principal Investigator Phil Wolfson, M.D., with Co-Therapist Julane Andries, L.M.F.T., this study is gathering preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety associated with diagnosis of a life-threatening illness in 18 participants. Learn more…
| $627,000estimated study cost | $218,000raised | $409,000still needed |
Donate Now |
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
Psychedelic Science and Neurodiversity
The Winter 2016 edition of the MAPS Bulletin features an article written by MDMA researcher Alicia Danforth, Ph.D., detailing her experience working with neurodivergent individuals in the MAPS-sponsored clinical trial of MDMA-assisted therapy for social anxiety in autistic adults. “We are looking forward to sharing our findings at the Psychedelic Science 2017 conference,” says Danforth. Learn more…
Medical Marijuana
Marijuana for PTSD: First Participant Enrolled in First-Ever Trial of Marijuana for Chronic PTSD in Veterans
On February 6, 2017, the first participant in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans received cannabis at the Scottsdale Research Institute (SRI) in Phoenix, Ariz. This is the first time this investigational drug has been dispensed to a participant in the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS)-sponsored clinical trial to evaluate the safety and efficacy of four different potencies of marijuana to manage symptoms of PTSD in 76 U.S. veterans.
By exploring the effectiveness of a variety of marijuana potencies, the study seeks to generate research data comparable to what veterans in medical marijuana states currently use. Results will provide vital information on marijuana dosing, composition, side effects, and areas of benefit to clinicians and legislators considering marijuana as a potential treatment for PTSD.
Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania’s Perelman School of Medicine, oversees the two separate study sites as Coordinating Principal Investigator (PI). Bonn-Miller states, “As this is the first placebo-controlled trial of cannabis for PTSD, we are breaking important ground needed to identify improved treatment options for veterans with PTSD.”
Half of the subjects will be enrolled at SRI in Phoenix, Ariz., led by Co-Investigator/Site PI Sue Sisley, M.D., and the other half at Johns Hopkins University in Baltimore, Maryl., led by Co-Investigator/Site PI Ryan Vandrey, Ph.D. Participant screening commenced on January 2, 2017, at SRI, and the first participant was officially enrolled on February 3. Johns Hopkins University commenced screening on January 19. Learn more…
Are You a U.S. Military Veteran with PTSD?
Adult military veterans who experienced trauma while in military service are needed for a research study. Study volunteers will complete 17 outpatient study visits over 12 weeks and a 6-month follow-up visit. The study will evaluate the effects of an investigational drug. Eligibility is determined by medical evaluation and modest compensation for participation is provided. All study visits occur at Scottsdale Research Institute and Johns Hopkins University. For more information, email arizona@marijuanasites.org (SRI) or call 410-550-0050 (JHU).
Ayahuasca Research
Survey: Ayahuasca for PTSD
As of January 31, 2017, we have received 268 completed responses for our new anonymous questionnaire about the potential risks and benefits associated with using ayahuasca as a therapy for posttraumatic stress disorder (PTSD). The data collection is being sponsored by MAPS, with Jessica Nielson, Ph.D., as the Principal Investigator for this study. Take the survey…
Learn more about current and upcoming research at maps.org.
Watch the Zendo Project train volunteers in psychedelic harm reduction at Burning Man 2016
Psychedelic Harm Reduction
Zendo Project: Volunteer at Lightning in a Bottle 2017
The Zendo Project will be offering psychedelic harm reduction services at Lightning in a Bottle 2017 in Bradley, California from May 24-29. We are currently accepting volunteer applications for Lightning in a Bottle and additional events. If you would like to provide psychedelic harm reduction services as a Zendo Project volunteer in 2017, please create/update a Zendo Profile and submit an application for the events that interest you. Apply to volunteer…
Learn about psychedelic harm reduction by signing up for the Zendo Project Email Newsletter, and following the Zendo Project on Facebook, Twitter, and Instagram
Support MAPS
January Giving Report: New Year, Big Goals
In January 2017, MAPS received over $40,000 in new donations and pledges from 290 supporters. The new year marks our final negotiations with the FDA as we move onto our final Phase 3 trials of MDMA-assisted psychotherapy for PTSD. We are still on track to make MDMA a medicine by 2021, but in the coming years our funding needs will grow substantially. Our Phase 3 studies will cost at least $25 million. With $10 million in hand, we still need your help to close this funding gap.
We extend a special thanks to those who generously supported MAPS this past month:
General Support
- Anonymous ($10,000)
- Ian Brown ($5,000)
- John Heilemann ($2,500)
- Dal LaMagna ($1,000)
GMP MDMA for MDMA/PTSD Phase 3
- Anonymous ($1,000)
- Anonymous ($1,000)
- Mark Smith ($1,000)
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
- John B. Stuppin ($3,000)
MAPS relies on the generosity of individual donors to achieve our mission. Psychedelic science is again being conducted under federal guidelines, but no funding for psychedelic psychotherapy research is yet available from governments or major foundations.
Help us reach our goal to make MDMA a medicine by 2021 by establishing a monthly gift of $10 or more. maps.org/donate
Learn how to include MAPS in your will or estate plans.
Learn more about hosting a Global Psychedelic Dinner to fundraise for MAPS.
Media
The Today Show, PBS NewsHour, WebMD, and more…
FEATURED
PRESS RELEASE
First Participant Enrolled in First-Ever Trial of Marijuana for Chronic PTSD in Veterans
MAPS | February 7, 2017
- FEATURED
PRESS RELEASE
Global Scientists Convene in California to Explore Breakthroughs in Psychedelic Science and Medicine
MAPS | February 6, 2017
The Today Show
Treating PTSD with Ecstasy? Clinical Trial Shows Groundbreaking Results
Janet Shamlian | January 15, 2017
PBS NewsHour
Why Psychedelic Drugs Are Having a Medical Renaissance
Miles O’Brien | January 25, 2017
CBS San Francisco Bay Area
Bay Area Patients Find Psychiatric Relief From Psychedelic Therapy
Molly McCrea and Cate Cauguiran | February 2, 2017
Military.com
Trial for PTSD Treatment with Ecstasy Ingredient to Open Soon
Amy Bushatz | January 26, 2017
WebMD
Hallucinogens: Future of Mental Health Treatment?
Matt Smith | January 13, 2017
The Daily Caller
Landmark Trial Looks To Treat PTSD In Veterans With Marijuana
Steve Birr | February 8, 2017
WIRED
Ever Had a Really Long Acid Trip? Now Science Knows Why
Matt Simon | January 26, 2017
San Francisco Chronicle
Psychedelic Drugs Altering Mainstream Medicine
April M. Short | January 13, 2017
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
MAPS Store
The Ketamine Papers: Science, Therapy, and Transformation
Edited by Phil Wolfson, M.D., and Glenn Hartelius, Ph.D.
Paperback | 448 pages | Published by MAPS (2016)
 |
“Here is an extraordinary collection of essays demonstrating that ketamine is more than just another molecule. If you are interested in the promise of ketamine as a tool of value in psychiatry, and/or you are interested in ketamine as a tool in exploring the nature of mind and the nature of what we call reality, then this book is for you!”
—David E. Presti, Ph.D., author of Foundational Concepts in Neuroscience: A Brain-Mind Odyssey
$24.95 | Get your copy today
MAPS Insulated Klean Kanteen Bottle
 |
Keep your drinks as hot as your passion for psychedelic research! Show your support for MAPS with this 20 oz. Kanteen that easily travels by your side.
Made from high-quality 18/8 food-grade stainless steel, this 20 oz. Kanteen shows your support for MAPS and easily travels by your side.
$30 | Buy now
Events
Browse our Event Calendar for more upcoming events.
Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
Join us from April 19-24, 2017, in Oakland, California, for Psychedelic Science 2017, a six-day international gathering featuring three days of Conference programming, three full days of Workshops, a Sunset Cruise on the San Francisco Bay, the world’s first Psychedelic Comedy Banquet, a free and expansive Marketplace of goods and ideas, participant-led Community Forums, and much more. Scientists, doctors, therapists, students, educators, policymakers, artists, and others from around the world will share recently completed and ongoing research into the risks and benefits of psychedelics and medical marijuana for science, medicine, spirituality, creativity, and more. Psychedelic Science 2017 is the third international Psychedelic Science conference, building on the success of Psychedelic Science in the 21st Century (2010) and Psychedelic Science 2013. Past Psychedelic Science conferences sold out early, so reserve your tickets soon. Register now for a 10% discount…
Psychedelic Science 2017 is presented by MAPS and The Beckley Foundation
A Good Trip Tour with Comedian Shane Mauss: February 13 – May 7, 2017, United States
Comedian Shane Mauss hosts a hilarious journey through the stigma, history, laws, and science of psychedelics in his new nationwide tour. Shane will share personal experiences and talk about the effects of psychedelics such as mushrooms, LSD, and DMT. Shane is an advocate for psychedelic studies a
nd rights, and psychedelics are also the source of some of the most hilarious, thought-provoking, and well-received material of his career. MAPS is proud to be an honorary sponsor of “A Good Trip.” Register…
Women and Cannabis Salon: March 4-5, 2017, San Francisco Bay Area, CA
Honor the connection between women and cannabis with the Women’s Visionary Council at the Women and Cannabis Salon in San Francisco and Oakland from March 4-5, 2017. Register…
Join the Women’s Visionary Council at Psychedelic Science 2017 in April for Psychedelic Culture and Community, a workshop featuring The Brotherhood of Eternal Love, The Tennessee Farm, The Hog Farm, and The Merry Pranksters. Buy tickets…
Students for Sensible Drug Policy (SSDP) Annual Conference: March 24-26, 2017, Portland, OR
Hosted by Students for Sensible Drug Policy (SSDP), SSDP2017 will bring more than 400 student members, alumni, and supporters to Portland, Oregon, from March 24-26, 2017, for their annual gathering. The conference will feature educational programming, an awards ceremony, a student congress, networking opportunities, and more. Register…
International Drug Policy Reform Conference: October 11-14, 2017, Atlanta, GA
The International Drug Policy Reform Conference is a biennial conference hosted by the Drug Policy Alliance (DPA), a leading drug policy reform organization. Taking place in Atlanta, Georgia, this event unites researchers, politicians, activists, and others for educational discussions about the global effects of the war on drugs. MAPS is a proud to be an official Co-Host of this event. Learn more…
Global Psychedelic Dinners
By hosting your own Global Psychedelic Dinner, you’ll join people around the world in gathering your community, having an open conversation about psychedelics, and raising funds to support MAPS. Host a dinner…