Newsletter: October 20, 2015

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As we—together—take the next steps towards making MDMA-assisted psychotherapy a legal treatment for PTSD, we are helping reintegrate psychedelics back into science, psychiatry, spirituality, and our culture at large.

On October 2 and 9, the last two subjects received their first experimental sessions in our study of MDMA-assisted psychotherapy for 23 subjects with chronic, treatment-resistant posttraumatic stress disorder (PTSD) in Boulder, Colorado. This will be the second largest study ever completed of MDMA-assisted psychotherapy for PTSD. The results will provide vital information for the design of our larger, multi-site Phase 3 studies, which we plan to begin in 2017.

We are also excited to announce that on September 28, MAPS Public Benefit Corporation (MPBC) initiated the purchase of one kilogram of MDMA certified under current Good Manufacturing Practices (GMP) from a UK pharmaceutical manufacturer. This supply will be used for our upcoming Phase 3 studies of MDMA-assisted psychotherapy for PTSD. See below to learn more about the history of MAPS MDMA.

The Summer 2015 MAPS Bulletin is now online and in subscribers’ mailboxes, including a complete update of our international research, news about our Zendo Project psychedelic harm reduction services, an overview of recent media coverage of our work, and my complete report on MAPS’ presence at the 2015 American Psychiatric Association annual meeting in Toronto, Canada.

In the October 2015 edition of the Multidisciplinary Association for Psychedelic Studies (MAPS) Email Newsletter, you’ll also find: 

• Starting November 4, join me for our latest five-course webinar in collaboration with Evolver Learning Lab. Early bird registration for Psychedelic Science and Spirituality: How to Apply What We’re Learning to Your Life ends October 26 ($25 off with coupon code MAPS).
• The eighth subject is treated in our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD
• The fifth subject is treated in our study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif.
• The Institutional Review Board at Johns Hopkins University approves the protocol design for our upcoming study of smoked marijuana for symptoms of PTSD in 76 U.S. veterans

Stay connected with the global psychedelic and medical marijuana research community—join MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.

We are starting to translate the healing experiences that psychedelics, used carefully, can provide into a language mainstream medicine can understand. Thank you for your continued support.

Always upward, Brad Burge MAPS Director of Communications and Marketing

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Treating PTSD with MDMA-Assisted Therapy

1. Boulder: Last Two Subjects Treated
2. Israel: Eighth Subject Treated
3. U.S Veterans: 17 of 24 Subjects Complete Long-Term Follow-Up
4. MPBC Purchases GMP MDMA Supply for Phase 3 Trials
5. MAPS
   Leads Seven-Day MDMA Therapist Training in South Carolina

MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness

6. Marin: Fifth Subject Treated

MDMA-Assisted Therapy for Social Anxiety in Autistic Adults

7. Social Anxiety in Autistic Adults: Ninth Subject Treated

Medical Marijuana for PTSD

8. Medical Marijuana for PTSD: Johns Hopkins IRB Approves Protocol Design

Support MAPS

9. September Giving Report: Trailblazing Psychedelic Medicine

Media

10. The Huffington Post, Nature, Al Jazeera America, and more…

MAPS Store

11. Acid Test: LSD, Ecstasy, and the Power to Heal by Tom Shroder NOW IN PAPERBACK
12. Zig Zag Zen: Psychedelics and Buddhism edited by Allan Badiner NEW EDITION

Events

13. Psychedelic Science and Spirituality: Starts November 4, 2015 WEBINAR
14. Science and Nonduality: October 22-25, 2015, San Jose, CA
15. Workshop: Trauma, the Body, and Psychedelic Medicine: October 24, 2015, Boulder, CO
16. International Drug Policy Reform Conference: November 18-21, 2015, Washington, D.C.
17. Psychedelic Science 2017: April 19-24, 2017, Oakland, CA

More News

18. Guadalajara Declaration Calls for Drug Policy Reform in Advance of UN Meeting
19. Johns Hopkins Online Survey: Psychedelic Use and Addiction
20. Thank You, Virginia!

 

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MDMA-assisted psychotherapy study participant Rachel Hope is featured in a new report on Al Jazeera America’s TechKnow. The episode aired on October 10, 2015. Read the article.

TREATING PTSD WITH MDMA-ASSISTED PSYCHOTHERAPY

1. Boulder: Last Two Subjects Treated

On October 2 and 9, 2015, the last two subjects were treated in our ongoing study of MDMA-assisted psychotherapy for 23 subjects with PTSD from sexual assault, violent crime, war, natural disasters, or any other cause, taking place in Boulder, Colorado. This will be the second-largest study ever conducted of MDMA-assisted psychotherapy for PTSD, having enrolled 19 women and nine men, with five subjects dropped out or excluded for not meeting study criteria, and 23 subjects to be included in a final analysis (all 29 will be included in our intent-to-treat analysis, a more conservative approach that analyzes data from all subjects enrolled in the study). Primary outcome data is anticipated to be available in December 2015. The final results will begin to be prepared for publication in early 2016, with publication expected in late 2016. Learn more…
$771,000 estimated study cost • $727,000 raised • $44,000 still needed

Learn about our Funding Priorities.

2. Israel: Eighth Subject Treated

On October 6, the eighth subject was treated in our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat up to 10 subjects with chronic, treatment-resistant PTSD from any cause. The Israeli team is seeking to enroll the final two subjects prior to November 1, when we will close enrollment in order to gather the data for submission to the U.S. Food and Drug Administration as part of our End-of-Phase 2 meeting, in preparation for Phase 3. This study is actively seeking Israeli participants. Learn more…
$509,000 estimated study cost • $92,000 raised • $417,000 still needed

3. U.S Veterans: 17 of 24 Subjects Complete Long-Term Follow-Up

As of September 23, 2015, 17 of 24 subjects have completed 12-month follow-up interviews in our nearly completed study of MDMA-assisted psychotherapy for U.S. veterans, firefighters, and police officers with chronic, treatment-resistant PTSD. L
ed by Principal Investigator Michael Mithoefer, M.D., and Co-therapist Annie Mithoefer, B.S.N., the data from this study are now being prepared for analysis and publication in a peer-reviewed scientific journal. “Over 900 people have contacted us about wanting to participate in our most recent study that had room for only 24 participants,” writes Dr. Mithoefer in his upcoming Winter 2015 MAPS Bulletin article. “Annie and I deeply appreciate the willingness of study participants to volunteer for our clinical trials, and to allow us to support them in their profound and challenging processes of healing.” Learn more…
$1,429,000 estimated study cost • $1,429,000 raised • funding complete

4. MPBC Purchases GMP MDMA Supply for Phase 3 Trials

On September 28, 2015, the MAPS Public Benefit Corporation initiated the purchase of one kilogram of 3,4-methylenedioxymethamphetamine (MDMA) certified under current Good Manufacturing Practices (GMP), from the UK pharmaceutical drug manufacturer Shasun. This supply will be used for our upcoming Phase 3 trials of MDMA-assisted psychotherapy for PTSD, which will begin in 2017. The GMP MDMA will not be any purer than our existing supply, but has been created with complete documentation and validation of all manufacturing procedures as required by the FDA and the European Medicines Agency (EMA) for use in Phase 3 trials.

The MDMA used in our current and completed U.S. Phase 1 and 2 trials was originally manufactured in 1985 by pharmacologist David Nichols, Ph.D., at Purdue University’s Department of Medicinal Chemistry, under contract to Earth Metabolic Design Lab, the non-profit that Rick Doblin started before MAPS. The original 1 kilogram supply cost $4000, or $4 per gram(the actual cost was lower since Nichols had an excellent yield and produced more than 1 kilogram). Approximately 960 grams of the original batch still remains. Our ongoing Israeli and Canadian studies, and our completed Swiss study, have used a different batch of MDMA manufactured in Switzerland by Lipomed, which no longer manufactures MDMA for clinical research. The new GMP MDMA will cost almost 100 times the cost of our original supply.

5. MAPS Leads Seven-Day MDMA Therapist Training in South Carolina

From October 4-11, 2015, MAPS hosted a seven-day training in Charleston, South Carolina, for therapeutic professionals interested in working on MAPS’ future clinical trials of MDMA-assisted psychotherapy for PTSD. The training was led by Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., along with Marcela Ot’alora, M.A., L.P.C., Principal Investigator of our ongoing study in Boulder. The weeklong training included 16 participants reviewing videos of MDMA-assisted psychotherapy sessions and discussing therapeutic techniques. Participants also completed a five-hour online training via our new online Training Portal prior to attending in person. The goals for this training were to educate therapists and potential researchers about MDMA-assisted psychotherapy methods, and to test our new educational model by conducting a pilot run of our expanded therapist training program (seven days instead of five).

From October 4-11, 2015, MAPS hosted a seven-day training in Charleston, South Carolina, for therapeutic professionals interested in working on MAPS’ future clinical trials of MDMA-assisted psychotherapy for PTSD.

MDMA-ASSISTED PSYCHOTHERAPY FOR ANXIETY ASSOCIATED WITH LIFE-THREATENING ILLNESS

6. Marin: Fifth Subject Treated

On September 21, 2015 the fifth subject received their first experimental session in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. Led by Principal Investigator Phil Wolfson, M.D., with co-therapist Julane Andries, LMFT, in Marin, Calif., this study will treat 18 subjects suffering from anxiety related to a life-threatening disease that is either ongoing or in remission with a possibility of recurrence. “With this much commitment of time, you get to know the people with whom you are working, and they get to know you,” writes Dr. Wolfson in his upcoming Winter 2014 MAPS Bulletin article. “Unlike with traditional psychotherapies, there is time for process; for handling transference and counter-transference; for meeting partners and friends; for staying in the trench and not pressuring to get out of it; for rectification, reframing, validation, and for the spirit to emerge; for agony and ecstasy…I am so pleased to have the time and the openness that MDMA-assisted psychotherapy engenders to know and feel, at a deep level, the people coming into our study.” We currently expect all experimental sessions in this study will be completed by late 2016. Learn more…
$627,000 estimated study cost • $194,000 raised • $433,000 still needed

MDMA-ASSISTED THERAPY FOR SOCIAL ANXIETY IN AUTISTIC ADULTS

7. Social Anxiety in Autistic Adults: Ninth Subject Treated

On September 26, the ninth subject was treated in our ongoing study of MDMA-assisted therapy for social anxiety in 12 adults on the autism spectrum. Sponsored by MAPS, this is a collaborative study between MAPS and the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, with blood plasma biomarker analysis being conducted by researchers at Stanford University. “One of the key factors contributing to this study running smoothly since it began in April 2014 has been early and ongoing consultation with members of the autism community, and with autistic individuals who provide professional support services for other adults on the autism spectrum,” write Principal Investigator Charles Grob, M.D., and Co-Investigator Alicia Danforth, Ph.D., in their upcoming report for the Winter 2015 MAPS Bulletin. “Detaching from preconceived notions and stereotypes about autism has been one of the most effective foundations for building therapeutic alliances.” Learn more at mdma-autism.org…
$336,000 estimated study cost • $12,000 raised + $15,000 raised by
partners • $309,000 still needed

MEDICAL MARIJUANA FOR PTSD

8. Medical Marijuana for PTSD: Johns Hopkins IRB Approves Protocol Design

On September 25, 2015, the Institutional Review Board (IRB) at Johns Hopkins University approved the protocol design for our upcoming study of smoked marijuana for symptoms of PTSD in 76 U.S. military veterans. The IRB will issue final approval for the study after the U.S. Drug Enforcement Administration (DEA) grants the Schedule I license for the study site in Phoenix, Ariz., and the study is listed on clinicaltrials.gov. The DEA will review the Phoenix study site when construction of the site is complete, and has already approved the specific refrigeration and security systems that we will use to store the study marijuana at the Phoenix site. The Principal Investigator (PI) for this study is Marcel Bonn-Miller, Ph.D., of the University of Pennsylvania. The Johns Hopkins study site is led by Site PI Ryan Vandrey, Ph.D., and the Phoenix site by Site PI Sue Sisley, M.D. Learn more…

Help make psychedelics and marijuana into prescription medicines—donate today!

SUPPORT MAPS

9. September Giving Report: Trailblazing Psychedelic Medicine

In September 2015, 192 individuals gave $40,362 to support MAPS’ psychedelic research and education programs. Every contribution, large or small, is greatly appreciated. We especially recognize those generous trailblazers who committed, advised, or gave $1,000 or more last month.

General Support
• Arjun Banker of the Banker Fund for Goodness at Fidelity Charitable ($10,000)
• Kathleen M. Shubin ($5,000)
• Jeffrey Kwatinetz ($5,000)
• Jessie Anne Rees ($1,300)

MDMA-Assisted Therapy for PTSD Research
• Gary Lippman through the Jewish Community Foundation ($5,000) for Israeli study
• Highfield Foundation ($2,500) for Boulder study

In addition to September’s successes, we’ve recently received a number of generous pledges. At our October 10 Raising the Bar dinner in New York City, we received $44,985 in donations and pledges. Laura Littlefield made a two-for-one matching pledge for $20,000 of the amount raised at our dinner event, giving $40,000 for our planned study of MDMA-assisted psychotherapy for the treatment of PTSD in couples. In addition, we received an $80,000 pledge from the Mental Insight Foundation, which will support our nearly completed study of MDMA-assisted psychotherapy for PTSD in U.S. veterans in South Carolina ($42,000), our Colorado MDMA/PTSD study ($8,000), and our study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness ($30,000). maps.org/donate

Learn about including MAPS in your will or trust.

MEDIA

10. The Huffington Post, Nature, Al Jazeera America, and more…

The Huffington Post: The Mind-Bending History of Buddhism and Psychedelics | view
Carolyn Gregoire | October 8, 2015

Al Jazeera America: Rebooting Psychedelic Science | view
Lauren Ellis | October 05, 2015

Nature: Israel, Research Without Prejudice | view
Emily Sohn | September 23, 2015

Reset.me: How Psychedelics Bring Relief To Veterans With PTSD | view
Aaron Kase | September 28, 2015

From Shock to Awe: Iraq War Veteran Tony Macie on His Experience with MDMA | view
Shock to Awe | September 12, 2015

Al Jazeera America: Not Your Stereotypical Psychedelic Drug User | view
Tracy Martinez| October 2, 2015

The Fix: How MDMA Helped One Veteran Overcome his PTSD | view
Nathan A Thompson | September 15, 2015

Gizmodo: When Are You Going to Get Your Prescription MDMA? | view
Cynthia McKelvey | September 21, 2015

CBC Radio: Psychologist Anthony Bossis: Can Psychedelic Drugs Help Ease the Fear of Death? | view
Mary Hynes | October 4, 2015

Drug Policy Alliance: Drug Policy Alliance to Host the Biennial 2015 International Drug Policy Reform Conference | view
Drug Policy Alliance | September 23, 2015

Al Jazeera America: MDMA and the Electronic Woodstock | view
Lauren Ellis | October 1, 2015

Explore MAPS in the Media for more psychedelic and medical marijuana research news.

MAPS Store

11. Acid Test: LSD, Ecstasy, and the Power to Heal by Tom Shroder

NOW IN PAPERBACK Anchoring Tom Shroder’s Acid Test are the stories of three men: Rick Doblin, the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), who has been fighting government prohibition of psychedelics for more than thirty years; Michael Mithoefer, a former emergency-room physician, now a psychiatrist at the forefront of psychedelic therapy research; and his patient Nick Blackston, a former Marine who has suffered unfathomable mental anguish from the effects of brutal combat experiences in Iraq. “As I researched this book, I couldn’t help but wonder: it had been 35 years since my last psychedelic experience.” Read more in the all-new Afterword by author Tom Shroder. PLUS: Join Nicholas Blackston and many others for our upcoming five-course webinar series on Psychedelic Science and Spirituality: How to Apply What We’re Learning to Your Life, starting November 4. Paperback $18.00 | Hardcover $27.95 $20.96 Now available

12. Zig Zag Zen: Psychedelics and Buddhism edited by Allan Badiner

NEW EDITION 304 pages | Published by Synergetic Press | 2015 Buddhism and psychedelic exploration share a common concern: the liberation of the mind. The new edition includes an expanded array of stunning art and six new contributions, including original essays by luminaries such as Ralph Metzner and Brad Warner; exciting interviews with James Fadiman, Kokyo Henkel, and Rick Doblin; and a discussion of ayahuasca’s unique influence on Zen Buddhism by Da vid Coyote. Art edited by Alex Grey. PLUS: Join Alan Badiner, Kokyo Henkel, Rick Doblin, and more for our upcoming five-course webinar series on Psychedelic Science and Spirituality: How to Apply What We’re Learning to Your Life, starting November 4. $26.95 | Now available

Learn how you can help make psychedelics and marijuana into prescription medicines at maps.org.

EVENTS

13. Psychedelic Science and Spirituality: How to Apply What We’re Learning to Your Life: Starts November 4, 2015

In this unique course from MAPS and Evolver Learning Lab, you will explore the frontier of current knowledge about psychedelics and spirituality, learn how researchers are studying these fascinating compounds, and discover how you can help create contexts for the safe and beneficial use of psychedelics for healing, spirituality, and personal growth. Brad Burge of the Multidisciplinary Association for Psychedelic Studies (MAPS) has invited a diverse and fascinating group of experts to help you understand, integrate, and learn to use insights from this transformative field. Learn more and register…

14. Science and Nonduality: October 22-25, 2015, San Jose, CA

MAPS Founder Rick Doblin, Ph.D., will be speaking on Sunday, October 25 at Science and Nonduality, a conference that provides a forum where preeminent scientists, philosophers, teachers, artists and the international community gather to explore the new paradigm emerging in spirituality, that is both grounded in cutting-edge science and consistent with the ancient wisdom of nonduality—the deep understanding of the interconnectedness of life. Register…

15. Workshop: Trauma, the Body, and Psychedelic Medicine: October 24, 2015, Boulder, CO

Trauma Dynamics is an experiential, strategic, somatic protocol that draws from current research on neurophysiology, memory systems, mindfulness and traumatic transference theory. Sponsored by MAPS, topics for this workshop will include the critical role the body plays in addressing trauma; mapping the autonomic nervous system and the intelligence of symptoms; understanding the memory systems involved in PTSD; working with anxiety, panic and dissociative symptoms as part of the healing process; understanding the value, opportunity and potential pitfalls of traumatic transference; the compelling results from MAPS’ Phase 2 clinical FDA trials of MDMA-assisted psychotherapy for treatment-resistant PTSD; and how psychedelics enhance the nervous system processing of trauma. This training has elements ofthe training MAPS provides to therapists preparing to treat subjects in MAPS-sponsored clinical research. Register…

16. International Drug Policy Reform Conference: November 18-21, 2015, Washington, D.C.

The International Drug Policy Reform Conference is a biennial event that brings together people from around the world who believe that the war on drugs is doing more harm than good. It brings together over 1,000 attendees representing 30 different countries. This year attendees will have the opportunity to spend three days interacting with people committed to finding alternatives to the war on drugs while participating in sessions given by leading experts from around the world. In addition, MAPS has assisted in the creation of a drug war vigil and protest on the Washington Mall, to take place during and immediately after the conference. Register…

17. Psychedelic Science 2017: April 19-24, 2017, Oakland, CA

Mark your calendars—it’s official! Psychedelic Science is coming back to the San Francisco Bay Area. The conference will return to the Oakland Marriott City Center in California from April 19-24, 2017. The conference will feature the latest findings in the psychedelic research community and is expected to sell out early. We are incredibly excited to start coordinating this monumental event. We will announce ticket sales, as well as opportunities to participate, closer to the date. For past conference information, speaker videos, and more from Psychedelic Science 2013, visit psychedelicscience.org.

MORE NEWS

18. Guadalajara Declaration Calls for Drug Policy Reform in Advance of UN Meeting

On October 5-6, 2015, approximately 100 academics, researchers, policymakers, students, journalists, and more gathered in Guadalajara, Mexico, for the Drogas, Política y Cultura: Perspectivas Brasil-México conference at the Centro de Investigaciones y Estudios Superiores en Antropología Social (CIESAS). Among the speakers were Brad Burge of MAPS, who presented a keynote address in Spanish on “Psychedelic Science and Medicine in the 21st Century.” Participants in the conference also signed the Guadalajara Declaration, which provides a series of recommendations in advance of the United Nations General Assembly Special Session on Drugs (UNGASS) 2016 for new public health-oriented and culturally appropriate policies towards drugs. “Academics rarely position themselves in relation to the drug war, which is still largely a taboo topic,” reports conference organizer Bia Labate, Ph.D. “Having Brazilian and Mexican academics getting out of the top of the fence and saying out loud ‘legalize marijuana,’ ‘give access to essential medicines,’ among others is a big achievement. Further, the text of the declaration is pretty progressive as it goes beyond decriminalization or harm reduction, pointing out that drugs are part of culture, and should be respected as legitimate things in themselves.” Read Brad Burge’s keynote address (English | Spanish) | Read the Guadalajara Declaration (English | Spanish | Portuguese)

19. Johns Hopkins Online Survey: Psychedelic Use and Addiction

Scientists at Johns Hopkins University School of Medicine are conducting an anonymous online survey study on the potential relationship between psychedelic experiences and reduction or cessation of addictive behaviors. This research has been approved by the Johns Hopkins University Institutional Review Board (IRB). Learn more about the survey…

20. Thank You, Virginia!

MAPS is very appreciative of Virginia Wright, M.B.A., who has been developing the base of supporters nationally for the past four years. Many of you had the opportunity to get to know Virginia Wright, our Director of Development who worked tirelessly to raise funds for MAPS over the past four years. Under Virginia’s excellent leadership, support from both new and long-time supporters increased significantly, and the fundraising and events procedures she put in place will endure. Virginia is returning to her consulting practice full time. While we will miss her as a staff member, we are happy that she will stay involved with MAPS. In conjunction with Virginia’s transition, Jade Netanya Ullmann will take the reigns as a Development Officer. For the past six months Virginia and Jade have worked closely ensuring a smooth transition. Erik Brown has also joined our staff as a Development Associate in our Santa Cruz, Calif., offices.