DEA Approves MAPS-Sponsored Study of MDMA Combined with Cognitive-Behavioral Conjoint Therapy for PTSD
“The Love Drug” Premieres on National Geographic, Exploring the History of MDMA in Science and Therapy
July 13, 2016
Dear friends and supporters,
Thank you for supporting psychedelic and medical marijuana research by staying connected through the Multidisciplinary Association for Psychedelic Studies (MAPS) Email Newsletter. This month, I’m excited to share with you the latest news in psychedelic and medical marijuana research and education.
We are finalizing the data from our international series of six Phase 2 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), and getting ready for our meeting with the U.S. Food and Drug Administration (FDA) later this year when we’ll come to an agreement on the design of the crucial Phase 3 studies required to make MDMA-assisted psychotherapy an approved treatment for PTSD.
Meanwhile, last month the U.S. Drug Enforcement Administration (DEA) approved the protocol for our upcoming study of MDMA-assisted psychotherapy for PTSD in couples. In this study, MDMA will be administered to both participants to facilitate communication and connection between participants and therapists. Led by Michael Mithoefer, M.D., and Candice Monson, Ph.D., this study has now received all required regulatory approvals, and will begin screening local participants in the South Carolina area this summer.
After almost seven years working to overcome regulatory and political obstacles, we are finally getting ready to start the world’s first clinical trial of smoked whole plant marijuana as a treatment for symptoms of PTSD. This study will enroll 76 U.S. veterans with chronic, treatment-resistant PTSD, and will be the first time a clinical trial intended to develop smoked marijuana into a legal prescription drug has received full approval from U.S. regulatory agencies.
In the July 2016 edition of the MAPS Email Newsletter, we’re also excited to share:
- The National Geographic Channel premieres “The Love Drug“, an all-new episode of I Am Rebel about the past, present, and future of MDMA in science and therapy
- The 13th participant is enrolled in our ongoing training study for therapists selected to work on MAPS-sponsored trials of MDMA-assisted psychotherapy for PTSD
- The 10th participant is treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif.
- June was PTSD Awareness Month! View our press release to learn more about why we need more effective treatments for PTSD.
Get the latest news and event announcements by following MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
Opportunities are everywhere for psychedelic science and medicine. From pioneering research and professional training opportunities to news documentaries and upcoming conferences, the field is truly expanding. Learn how your gift makes a difference.
Upwards together,
Brad Burge
MAPS Director of Communications and Marketing
Contents
Treating PTSD with MDMA-Assisted Therapy
1 Conjoint Therapy: DEA Approves Study Protocol
2 Therapist Training Study: 13th Participant Enrolled
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
3 Marin: Tenth Participant Treated
Medical Marijuana Research
4 Marijuana for PTSD: Investigator Meetings and Initiation Visits Begin
Ayahuasca Research
Psychedelic Harm Reduction
6
Zendo Project: Placement Announced for Burning Man 2016
Support MAPS
7 June Giving Report: Summer Support for Psychedelic Science
Media
8 National Geographic, Vox, Refinery29, Playbill, and more…
MAPS Store
9 Psychedelic Drug Treatments: Assisting the Therapeutic Process by Dr. Ben Sessa and Eileen Worthley
10 Sacred Knowledge: Psychedelics and Religious Experiences by William A. Richards
Events
11 Psychedelic Awareness Salon: July 20, 2016, San Diego, CA
12 Float Conference: August 20-21, 2016, Portland, OR
13 Beyond Psychedelics: September 30-August 2, 2016, Prague, Czech Republic
14 Psychedelic Psychotherapy Forum: October 14-15, 2016, Victoria, BC
15 World Ayahuasca
Conference: October 17-22, 2016, Rio Branco, Brazil
16 Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
More News
17 The Ayahuasca Defense Fund Launches Crowdfunding Campaign
National Geographic presents I Am Rebel: The Love Drug, a documentary exploring the history of MDMA in therapy, science, and culture.
Treating PTSD with MDMA-Assisted Therapy
Conjoint Therapy: DEA Approves Study Protocol
On June 14, 2016, the U.S. Drug Enforcement Administration (DEA) approved the protocol for our upcoming study of MDMA combined with Cognitive-Behavioral Conjoint Therapy (CBCT) for treating PTSD. Led by Principal Investigator Michael Mithoefer, M.D., and Sub-Investigator Candice Monson, Ph.D., this will be a pilot Phase 1/Phase 2 open-label study of CBCT integrated with MDMA for the treatment of chronic posttraumatic stress disorder (PTSD). Dr. Monson is a leading expert on individual and conjoint cognitive therapies to treat PTSD.
The study will enroll 10 dyads, each pair with one participant diagnosed with PTSD and one concerned significant other who does not have PTSD but does experience psychosocial distress. This is the first MAPS-sponsored MDMA study conducted with VA-affiliated researchers and the first to employ measures developed for the DSM-5. The primary goal of this study is to explore 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. The study has received approval from all necessary government agencies, and will begin screening local participants residing around South Carolina for enrollment this summer. Learn more…
| $200,000estimated study cost | $165,000raised to date | $35,000still needed |
Donate Nowhelp fund this study |
Therapist Training Study: 13th Participant Enrolled
On July 5, 2016, the 13th participant was enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when taken in a therapeutic setting by healthy volunteers. Enrollment in this study is limited to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD, with enrollment by invitation only. The Principal Investigator of this study is Michael Mithoefer, M.D. On May 9, in preparation for expanding our MDMA-assisted psychotherapy for PTSD development program into Phase 3, we submitted an amendment to the study protocol to the FDA. The amendment included increasing total enrollment to 100 participants and adding a second site in Boulder, Colorado, under the direction of Marcela Ot’alora, M.A., L.P.C., in order to increase enrollment to cover training needs over the next five years. The FDA gave clearance for the third protocol amendment on June 21, 2016. “We felt quite strongly that we should go through the therapist’s training,” says study participant Dr. Mathew Hoskins in a recent interview with Inverse. “We’re asking our participants in our study to do really quite a lot.” Learn more…
| $429,000estimated study cost | $35,000raised to date | $394,000still needed |
Donate Nowhelp fund this study |
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: Tenth Participant Treated
On June 6, 2016, the tenth 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 treating anxiety in 18 subjects diagnosed with a life-threatening illness. Study participant Andy Gold speaks about his experience with MDMA-assisted psychotherapy, stating, “It has this incredible capacity for opening you up to yourself.” Watch the video… | Learn more…
| $627,000estimated study cost | $213,000raised to date | $414,000still needed |
Donate Nowhelp fund this study |
Filmmaker Vikram Gandhi interviews researcher Ingmar Gorman, Ph.D. (c), to discuss clinical studies of MDMA-assisted psychotherapy for PTSD.
Medical Marijuana Research
Marijuana for PTSD: Investigator Meetings and Initiation Visits Begin
Study Coordinator Christine Lizarraga, Principal Investigator Sue Sisley, M.D., and DEA Consultant Anthony Coulson
From June 6-16, 2016, a series of investigator meetings and initiation visits took place in preparation for our upcoming study of smoked marijuana for symptoms of PTSD in 76 U.S. veterans. Principal Investigators, study coordinators, and study physicians met in Palo Alto, CA, Baltimore, MD, and Phoenix, AZ, to discuss study procedures, receive training on the electronic platforms to be used in the study, and review protocols for recruitment, enrollment, and study publicity. Discussions at these meetings led to an amendment to the study protocol to clarify several study procedures and adjust study measures. Once the amendment has been approved by the Institutional Review Boards (IRBs) at the Scottsdale Research Institute (Phoenix) and Johns Hopkins University (JHU), we will be able to begin recruiting and enrolling participants. We currently expect that this study will begin in August 2016. Learn more…
Ayahuasca Research
Survey: Ayahuasca for PTSD
A new anonymous questionnaire is gathering preliminary data about the potential risks and benefits associated with taking ayahuasca as a therapy for posttraumatic stress disorder (PTSD). The data collection is being sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). Jessica Nielson, Ph.D., is the Principal Investigator for this study. Learn More… | Take the survey…
Learn more about current and upcoming research at maps.org.
Psychedelic Harm Reduction
Zendo Project: Placement Announced for Burning Man 2016
Zendo Project volunteers will provide psychedelic harm reduction services at Burning Man from August 29-September 5, 2016. This year, the Zendo will be located near the 9:00 and 3:00 keyholes (on D between 3:00 and 3:15, and on D between 9:00 and 9:15).
The Zendo Project Psychedelic Harm Reduction training will take place on Tuesday, August 30, from 11:00 AM-2:00 PM in the ReFOAMation Village speaker dome at 2:15 and E. The Zendo Project will also be hosting an Intention Setting Ceremony and an Integration Circle during the week.
If you are interested in donating blankets, pillows, or warm clothing for guests, please contact zendo@maps.org. We’re also seeking donations of funds since our estimated budget is $75,000 to demonstrate this model psychedelic harm reduction program at Burning Man. Learn More… | Donate…
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
June Giving Report: Summer Support for Psychedelic Science
In June 2016, MAPS received over $350,000 in new donations from nearly 240 supporters. We extend a special thanks to those who so generously supported MAPS this past month:
General Support
- Dr. Bronner’s ($200,000)
- Adam Wiggins ($60,000)
- Robert W. Kellogg Charitable Trust ($40,000)
- Jud Ireland ($10,000)
- Jared Luxenberg ($1,500)
- Anonymous ($1,000)
- Annonymous ($1,000)
- Rose Marsh Boyle ($1,000)
- Robert Gansser ($1,000)
- William F. Harrison ($1,000)
- Richard Louis Miller ($1,000)
- Mark Smith ($1,000)
- Andrew Tartarsky ($1,000)
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults Study
- Erowid Center ($1,650)
Marijuana for PTSD Study
- Julie Holland ($1,396)
Marijuana for Opioid Addiction Study
- David Tuttleman ($5,000)
- Steven Trenk ($5,000)
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. Learn about hosting a Global Psychedelic Dinner to gather your community and support MAPS.
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, commerce, and innovation. Cover art by Cameron Gray.
Media
National Geographic, Vox, Refinery29, Playbill, and more…
FEATURED
National Geographic
June 19, 2016
FEATURED
PRESS RELEASE
PTSD Awareness Month Highlights Need for More Effective Treatments
Brad Burge | June 29, 2016
Volteface
Trips and Traps: Psychedelics Seek Legitimacy in the World of Modern Medicine
Abi Millar | June 29, 2016
Vox
The Fascinating, Strange Medical Potential of Psychedelic Drugs, Explained in 50+ Studies
German Lopez and Javier Zarracina | June 27, 2016
Refinery29
How Psychedelic Drugs Might Help Treat Mental Illness
Sarah Jacoby | June 14, 2016
Playbill
The Mushroom Cure, True Tale of Psychedelics, Will Be Seen Off-Broadway
Olivia Clement | June 20, 2016
How We Get To Next
Go on a ‘Trip’ and Cure Your Depression
Corin Faife | June 25, 2016
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
MAPS Store
Psychedelic Drug Treatments: Assisting the Therapeutic Process by Dr. Ben Sessa and Eileen Worthley
 |
Paperback | 211 pages | Mercury, 2016
This book will introduce you to the way in which the chemical compounds known as psychedelics affect the brain, provide definitions of key terms, describe the specific disorders that may be relieved through treatment with psychedelics, and offer information about current research.
$24.95 | Now available
Sacred Knowledge: Psychedelics and Religious Experiences by William A. Richards
 |
Paperback | 280 pages | Columbia University Press, 2015
“Richards seamlessly weaves together his extensive understanding of spirituality on the one hand and academic and clinical science on the other – a rare combination. His humour, insights, and empathy shine through on every page. The topic is timely and a manifestation of the fact that the intellectual battle regarding the potential of nonordinary states of consciousness (as, in this case, facilitated by psychedelics) has been won.” —Amanda Feilding, Director, The Beckley Foundation
$28.95 | Now available
Events
Psychedelic Awareness Salon: July 20, 2016, San Diego, CA
The new San Diego chapter of Aware Project: Rethinking Psychedelics will host MAPS Founder Rick Doblin, Ph.D., for a presentation about psychedelic research on July 20, 2016. This event is a fundraiser for MAPS’ work toward lifting the stigma about psychedelics through scientific research, and will include catered dinner, a drink ticket, education, entertainment, and abundant opportunity for conversations. Purchase tickets…
Float Conference: August 20-21, 2016, Portland, OR
MAPS Founder and Executive Director Rick Doblin, Ph.D., will present at the the world’s largest float tank event. Join experts from around the world and discuss new research being conducted with float tanks, the current state of regulations, as well as marketing strategies used by the biggest and most successful floatation centers. Register…
Beyond Psychedelics: September 30-August 2, 2016, Prague, Czech Republic
MAPS Founder and Executive Director Rick Doblin, Ph.D., will present at Beyond Psychedelics, the first global psychedelic forum in Czech Republic. The event will provide outside-the-box discussions on the approaches to working with psychedelics and the positions these substances hold in our modern society. Register…
Psychedelic Psychotherapy Forum: October 14-15, 2016, Victoria, BC
MAPS Founder and Executive Director Rick Doblin, Ph.D., will give the keynote address at this year’s forum. Highlighted topics will include the current state of MDMA research for alleviating PTSD; ayahuasca therapy to treat eating disorders; psilocybin studies and their implications for cancer patients and end-of-life issues; training possibilities for psychedelic psychotherapists; and how to support clients in successfully integrating the psychedelic experience. Register…
World Ayahuasca Conference: October 17-22, 2016, Rio Branco, Brazil
MAPS is a proud co-sponsor of the 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 ab
out cultural recognition and protection of traditional practices worldwide is more important than ever. Register…
Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
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. Psychedelic Science is expected to sell out early, so be sure to get your tickets early—advance tickets will be on sale soon. Learn more….
More News
The Ayahuasca Defense Fund Launches Crowdfunding Campaign
MAPS serves as a non-profit fiscal sponsor for the Ayahuasca Defense Fund (ADF), a project supporting legal defense for the ethical and responsible use of ayahuasca and other psychoactive plants. ADF is currently working with experts from around the world to address the role of ayahuasca in policy and science. Learn more…