DEA Approves Clinical Trial of Medical Marijuana for PTSD
Worldwide benefit events raise over $141,000 for GMP MDMA purchase
May 11, 2016
Dear friends and supporters,
Thank you for subscribing to the Multidisciplinary Association for Psychedelic Studies (MAPS) Email Newsletter. By staying informed and spreading the word, you’re supporting our work to educate the public honestly about the risks and benefits of psychedelics and marijuana for healing, spirituality, creativity, and personal growth.
Right now, we are preparing to submit the data from our Phase 2 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) to the U.S. Food and Drug Administration (FDA). Our submission will include data from 136 participants in our Phase 2 trials. This summer, we’ll meet with FDA officials in Washington, D.C., to agree on the design our Phase 3 trials—with 200 or more additional participants—which we anticipate starting in early 2017.
On April 19, the U.S. Drug Enforcement Administration (DEA) gave its final approval for our long-awaited trial of smoked marijuana for PTSD in 76 U.S. veterans. This is a major accomplishment, marking the first time that a clinical trial intended to develop the marijuana plant in smoked form into an FDA-approved prescription medicine has received full regulatory approval. We expect to begin the study this year, once we receive the marijuana from the National Institute on Drug Abuse (NIDA).
Since the Global Psychedelic Dinners launched in March, our worldwide supporters have hosted over 80 dinners in 16 countries, with more continuing through May. Over 900 people joined us in person at our 30th Anniversary Banquet and Celebration on April 17. Together, these worldwide benefit events have raised $141,634 (and counting) of the $400,000 needed for MAPS’ purchase of one kilogram of pharmaceutical grade (GMP) MDMA for our Phase 3 trials of MDMA-assisted psychotherapy for PTSD and other MDMA research worldwide. Watch the video!
In the May 2016 edition of the MAPS Email Newsletter, you’ll also find:
- The eighth participant is treated in our study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif.
- Marin study participants John, Andy, and Wendy share their experience in a new video
- The 11th participant receives MDMA-assisted psychotherapy in our therapist training study
- The Wall Street Journal, Fortune, The Washington Post, and more report on MAPS’ psychedelic and medical marijuana research
- Early Bird tickets for Psychedelic Science 2017—coming this April 19-24, 2017, to Oakland, Calif.—are on sale soon
Spread the word and stay in touch by following MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
Right now, opportunities are everywhere for the continued expansion of psychedelic and medical marijuana research. With our voices together, and all of us giving what we can, we are creating safe, legal ways for people to benefit from the careful uses of psychedelics and marijuana.
MAPS Director of Communications and Marketing
Medical Marijuana Research
1Marijuana for PTSD: DEA Approves First-Ever Trial of Medical Marijuana for PTSD in Veterans
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
2Marin: Eighth Participant Treated; Two More Enrolled
Treating PTSD with MDMA-Assisted Therapy
3Therapist Training: 11th Participant Treated
More MDMA Research
4Updated MDMA Investigator’s Brochure Now Available Online
5The Lancet Psychiatry Publishes Review Article on Novel Psychedelic Therapy Treatments
6Global Psychedelic Dinners and 30th Anniversary Banquet Raise $141,634+ for MDMA Research
7April Giving Report: Celebrating 30 Years of Psychedelic Research and Education
8The Wall Street Journal, Washington Post, Fortune, and more…
10The Pot Book: A Complete Guide to Cannabis edited by Julie Holland, M.D.
11Interdisciplinary Conference on Psychedelics Research: June 3-5, 2016, Amsterdam
12 Women’s Visionary Congress: June 17-19, 2016, Petaluma, Calif.
13Sumiruna Awakenings Conference: June 23-26, 2016, Bucharest, Romania
14World Ayahuasca Conference: October 17-22, 2016, Rio Branco, Brazil
15 Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
Watch the entire MAPS 30th Anniversary Banquet and Celebration online now.
Medical Marijuana Research
Marijuana for PTSD: DEA Approves First-Ever Trial of Medical Marijuana for PTSD in Veterans
On April 19, 2016, the U.S. Drug Enforcement Administration (DEA) formally approved the first-ever randomized controlled trial of whole plant medical marijuana (cannabis) as a treatment for PTSD in U.S. veterans. The DEA’s approval marks the first time a clinical trial intended to develop smoked botanical marijuana into a legal prescription drug has received full approval from U.S. regulatory agencies, including the DEA, FDA, and Institutional Review Boards (IRBs) at the University of Pennsylvania, Johns Hopkins University, and the Copernicus IRB. The randomized, blinded, placebo-controlled study will test the safety and efficacy of botanical marijuana in 76 U.S. military veterans with treatment-resistant PTSD. The study is funded by a $2.156 million grant from the Colorado Department of Public Health and Environment (CDPHE) to MAPS, which is sponsoring the study. MAPS’ study protocol will be replicated using vaporization by the Canadian medical marijuana producer Tilray, and by the University of Sydney using Tilray extracts in orally administered capsules. View the press release | Learn more…
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: Eighth Participant Treated; Two More Enrolled
On April 18, 2016, the eighth participant was treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif. 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. The eighth participant was enrolled on April 4 (after the previous participant dropped out), and the ninth and 10th participants were enrolled on April 14. “These visions would bubble up and come to me piece by piece,” recalls study participant John Saul of Sausalito, Calif. “My heart really cracked open. It helped me overcome my fear-based defenses.” On May 3, MAPS was a proud participant in Silicon Valley Gives, an online fundraising effort led by the Silicon Valley Community Foundation with proceeds supporting this trial. Watch the video | Learn more…
Help complete non-profit research in Marin, Calif., of MDMA-assisted psychotherapy to treat anxiety associated wit
h life-threatening illness.
Treating PTSD with MDMA-Assisted Therapy
Therapist Training: 11th Participant Treated
On March 19, 2016, the 11th participant was treated in our ongoing Phase 1 study of MDMA-assisted psychotherapy for therapists in training to conduct clinical trials of MDMA-assisted psychotherapy for PTSD, with enrollment by invitation only. Led by Principal Investigator Michael Mithoefer, M.D., this study is a placebo-controlled, double-blind study to assess the psychological effects of MDMA when administered to healthy volunteers in a therapeutic setting. On May 4, in preparation for Phase 3 of our MDMA-assisted psychotherapy for PTSD development program, we submitted to the FDA a series of amendments to the study protocol. The amendments include increasing total enrollment to 100 participants and adding a new location in Boulder, Colorado, under the direction of Marcela Ot’alora, in order to increase enrollment to cover training needs over the next five years. Learn more…
More MDMA Research
Updated MDMA Investigator’s Brochure Now Available Online
Our MDMA Investigator’s Brochure (8th edition: March 30, 2016) evaluates the peer-reviewed scientific literature about MDMA and describes the physical, chemical, and pharmacological characteristics of MDMA, its effects in nonclinical and clinical studies, and the safety profile of MDMA-assisted psychotherapy. This brochure focuses on research and information relevant to researchers and regulators engaged in clinical trials with MDMA. Download | Learn more…
The Lancet Psychiatry Publishes Review Article on Novel Psychedelic Therapy Treatments
On April 5, 2016, the prestigious peer-reviewed journal The Lancet Psychiatry published a new article by psychedelic therapy researchers Michael Mithoefer, M.D., Charles Grob, M.D., and Timothy Brewerton, M.D., discussing the promise of MDMA and psilocybin for enhancing the effectiveness of therapy for a range of psychiatric conditions. “This model of drug-assisted psychotherapy is a possible alternative to existing pharmacological and psychological treatments in psychiatry,” the authors write in the abstract. “Further research is needed to fully assess the potential of these compounds in the management of these common disorders that are difficult to treat with existing methods.” View online… (login required)
Learn more about current and upcoming research at maps.org.
Global Psychedelic Dinners and 30th Anniversary Banquet Raise $141,634+ for MDMA Research
Since the Global Psychedelic Dinners launched in March, our worldwide supporters have hosted over 80 dinners in 16 countries, with more continuing through May. Over 900 people joined us in person at our 30th Anniversary Banquet and Celebration on April 17. Together, these worldwide benefit events have raised $141,634 of the $400,000 needed for MAPS’ purchase of one kilogram of pharmaceutical grade (GMP) MDMA for our Phase 3 trials of MDMA-assisted psychotherapy for PTSD and other MDMA research worldwide.
Some Global Psychedelic Dinners are taking place in May, so you may still be able to find a dinner in your area. Plus, if you still want to host a Global Psychedelic Dinner, you still can! Visit psychedelicdinners.org to learn how.
We could not be more grateful, or more encouraged, by the outpouring of support our work has received from the global community. Thank you for helping make MDMA-assisted psychotherapy a legal treatment.
Thank you to George Goldsmith and Ekaterina Malievskaia for their inspiring $25,000 matching gifts, and to Steve Chapman ($18,000), Susan and René Ruiz ($10,000), and Carey and Claudia Turnbull ($5,000) for their matching gifts, and to our sponsors.
April Giving Report: Celebrating 30 Years of Psychedelic Research and Education
In April 2016, MAPS received over $82,000 in donations from over 600 supporters. Our work saw generous support this month as we celebrated our 30th anniversary. Over 900 attendees joined came us on April 17 for our 30th Anniversary Banquet and Celebration in Oakland, Calif., and over 80 Global Psychedelic Dinners have taken place around the world. Since February, we have raised nearly $141,000 through our 30th Anniversary and Global Psychedelic Dinners for our purchase of one kilogram of GMP MDMA for our Phase 3 studies of MDMA-assisted psychotherapy for PTSD and other MDMA research worldwide.
We are exceptionally grateful to all who have generously supported MAPS over the past three decades. We give special thanks to these donors from the past month:
- HeadCount ($7,587.88)
- Church of the Merciful Gardener ($5,000)
- ONACS of Open Path ($5,000)
- Hania Withem ($5,000)
- Cody Bass ($4,453)
- Candra Docherty through Arising Fund ($1,500)
- Allan Badiner ($1,000)
- Jeff Mease ($1,000)
Marijuana for PTSD
- Adam Denmark Cohen ($2,500)
MDMA-Assisted Therapy for PTSD (Israel)
- Ann Garson ($4,000)
Ibogaine Treatment for Addiction (Mexico)
- Benjamin Marinoff ($1,000)
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 therapy research is yet available from governments or major foundations. Learn how to include MAPS in your will or estate plans.
The Spring 2016 Special Edition of the MAPS Bulletin is now available online, featuring over a dozen original articles on the growing role of psychedelics and marijuana in business, philanthropy, c
ommerce, and innovation. Cover art by Cameron Gray.
The Wall Street Journal, Washington Post, Fortune, and more…
DEA Approves First-Ever Trial of Medical Marijuana for PTSD in Veterans
The Mercury News
Meet MAPS, the Psychedelic Research Foundation That’s Winning Silicon Valley Gives
The Psychedelic Times
Wall Street Journal
The Washington Post
DEA Greenlights Marijuana Study to Measure Pot’s Effect on PTSD
The DEA Just Approved a Way to Smoke Marijuana Legally for the First Time
The Phoenix New Times
Massive National Drug Deal Set to Take Place (for a Good Cause)
Psychedelic Activists Aren’t the LSD-Dropping Hippie Flakes You Think They Are
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
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Learn about psychedelic harm reduction by signing up for the Zendo Project Email Newsletter, and following the Zendo Project on Facebook and Twitter.
Interdisciplinary Conference on Psychedelics Research: June 3-5, 2016, Amsterdam
MAPS is a proud sponsor of the third international Interdisciplinary Conference on Psychedelics Research, organized by the OPEN Foundation. During this three-day event, international researchers from a wide range of academic disciplines will present their latest results and advances in scientific research on psychedelics. ICPR will include presentations by MAPS Founder and Executive Director Rick Doblin, Ph.D., and Colorado MDMA-assisted psychotherapy for PTSD Principal Investigator Marcela Ot’alora. ICPR is a multidisciplinary, strictly scientific conference featuring the most current research on psychedelic substances. Register…
Women’s Visionary Congress: June 17-19, 2016, Petaluma, Calif.
Join the Women’s Visionary Congress this June for the 10th annual Women’s Visionary Congress. The three-day event features conversations with researchers, healers, activists and artists who examine heightened states of awareness and modes of healing that link us to female wisdom keepers and traditional users of plant medicines throughout history. The Congress will take place at the Institute of Noetic Sciences (IONS) Earthrise Retreat Center in Petaluma, California, about forty minutes north of San Francisco. Register…
Sumiruna Awakenings Conference: June 23-26, 2016, Bucharest, Romania
As the first Eastern European conference about expanded states of consciousness and visionary art, the Sumiruna Conference brings together some of the world’s leading authors, visionaries, artists, researchers, and teachers to Romania, to discuss what can be gained and to share the latest research and techniques for exploring consciousness. Learn more and register…
World Ayahuasca Conference: October 17-22, 2016, Rio Branco, Brazil
MAPS is a proud co-sponsor of th
e 2016 World Ayahuasca Conference. Two years after the first World Ayahuasca Conference, held in Ibiza, Spain, the international ayahuasca community will come together in the spirit of the dialogue and exchange of knowledge and experience initiated in the first edition. In times of a rapid globalization of the use of ayahuasca, the dialogue about cultural recognition and protection of traditional practices worldwide is more important than ever. Call for Abstracts…
Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
TICKETS ON SALE SOON, 2016
Join us from April 19-24, 2017, in Oakland, California, for Psychedelic Science 2017, a five-day global gathering featuring three days of conference programming, full-day workshops, an evening cruise on the San Francisco Bay, a celebratory banquet, a free and expansive marketplace of goods and ideas, and much more. The three-day conference will include three simultaneous tracks of presentations by leading and up-and-coming international researchers in the fast-growing field of psychedelic science and medicine. Psychedelic Science is expected to sell out early, so be sure to get your tickets early. Volunteer opportunities and a call for presentations and posters will be announced soon. For past conference information, speaker videos, and more, visit 2013.psychedelicscience.org. Psychedelic Science 2017 is presented by MAPS and The Beckley Foundation. Tickets will be on sale soon.