FDA Accepts Protocol for New Study of MDMA-Assisted Therapy for Couples with PTSD
Global Psychedelic Dinners connect communities worldwide to share their stories and fund psychedelic therapy research
February 12, 2016
Dear friends and supporters,
As we, the Multidisciplinary Association for Psychedelic Studies (MAPS), complete the final treatments and evaluations in our international series of Phase 2 studies of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), and prepare for the Phase 3 studies required to make it a legal treatment, we found a fun—and delicious—new way for our supporters around the world to get involved.
Since we announced the Global Psychedelic Dinners last week, over 84 people in 12 countries have already registered to gather their community, host an open conversation about psychedelics and psychedelic experiences, and help raise $400,000 for MAPS’ purchase of one kilogram of pharmaceutical-grade (GMP) MDMA for clinical trials around the world, including our Phase 3 trials of MDMA-assisted psychotherapy for PTSD. Will you join our team?
We also hope you’ll join us on April 17 at the magnificent Oakland Scottish Rite Center in the San Francisco Bay Area for our 30th Anniversary Banquet and Celebration. We’ll celebrate three decades of pioneering advances in psychedelic research, therapy, and education, and build the future of psychedelic medicine with a fundraiser to support our GMP MDMA purchase. Tickets and Sponsorships are now available.
In the February 2016 edition of the MAPS Email Newsletter, you’ll also find:
- The protocol for our new and upcoming study of MDMA-assisted psychotherapy for PTSD in couples is approved by the FDA
- The last participant is treated in our ongoing study of MDMA-assisted therapy for social anxiety in autistic adults
- The U.S. Drug Enforcement Administration (DEA) inspects the Johns Hopkins University site for our upcoming study of marijuana for symptoms of PTSD in U.S. veterans
- Co-therapist teams are now being selected and trained for Phase 3 trials of MDMA-assisted psychotherapy for PTSD
Working together, we are making psychedelic therapy a legal treatment, and creating safe and legal ways for people to use psychedelics and marijuana for healing, exploration, spirituality, creativity, and personal growth. What keeps us moving towards our goals is the participation of an expanding, worldwide community of people who are transforming the world. Thank you for joining us.
MAPS Director of Communications and Marketing
P.S. Have you seen this historical document? MAPS Founder and Executive Director Rick Doblin, Ph.D., is asking if you have the following document, which he wrote but failed to keep a copy: Doblin, R. Murmurs in the Heart of the Beast: MDMA and the DEA, HHS, NIDA, NIMH, ADAMHA, FBI and the WHO. Privately printed. August 8, 1984. This is a report from Rick to other activists about the positions of various federal agencies leading to DEA’s 1985 Emergency Scheduling of MDMA. If you’ve seen it, please let us know.
Treating PTSD with MDMA-Assisted Therapy
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
Medical Marijuana Research
Treating PTSD with MDMA-Assisted Therapy
Israel: Last Participant Receives First Treatment
On January 13
, 2016, the tenth and final subject received their first treatment in our Phase 2 Israeli study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat 10 subjects with chronic, treatment-resistant PTSD from any cause. Once the final treatments and evaluations are complete, we will gather data for inclusion in an international meta-analysis of the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. Israeli study of MDMA-assisted psychotherapy for PTSD. Learn more…
|$509,000estimated study cost||$92,000raised to date||$417,000still needed||
Boulder: Last Participant Completes Two-Month Follow-Up Interview
On February 5, 2016, the 23rd and final participant had their two-month follow-up evaluation in our Phase 2 study of MDMA-assisted psychotherapy for 23 subjects with chronic, treatment-resistant PTSD in Boulder, Colorado. All subjects have now completed active study participation and have proceeded to 12-month long-term follow-up. Long-term follow-up data will provide additional information to guide the design of our upcoming Phase 3 trials. In December 2015, we asked our supporters to help fund the final $44,000 needed to complete this study. The campaign was an inspiring success, raising $66,457 for the research, with the additional funds supporting additional clinical trials of MDMA-assisted psychotherapy for PTSD. The final results will be prepared for publication in early 2016, with publication expected in late 2016. Learn more…
|$771,000estimated study cost||$771,000raised to date||Funding
NEW Conjoint Therapy: FDA Accepts New Study Protocol.
On January 26, 2016, the U.S. Food and Drug Administration (FDA) accepted the protocol for our upcoming study of MDMA-assisted psychotherapy for PTSD in couples. 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 exploring Cognitive-Behavioral Conjoint Therapy (CBCT) integrated with MDMA-assisted psychotherapy for the treatment of chronic posttraumatic stress disorder (PTSD). Candice Monson, a developer of CBCT, was introduced to MAPS by the U.S Department of Veterans Affairs National Center for PTSD.
The study will enroll 10 pairs of participants, each with one participant diagnosed with PTSD, and one concerned significant other who does not have PTSD. There are several important reasons to include significant others in PTSD treatment, in addition to the data supporting the efficacy of CBCT for PTSD. MDMA will be administered to both participants to help facilitate communication and connection between participants and therapists. Learn more…
|$220,000estimated study cost||$65,000raised to date||$155,000still needed||
NEW Therapist Training Program: Subscribe to Receive Updates
The MAPS Therapist Training Program plans to train approximately 300 therapists before 2021, when we anticipate completing Phase 3 clinical trials investigating MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD. Co-therapist teams are now being selected and trained for Phase 3 trials to begin in 2017. MAPS may be able to apply for a special designation with the U.S. Food and Drug Administration (FDA) for Expanded Access to MDMA-assisted psychotherapy before 2021. Only therapists who have completed the MAPS Therapist Training Program will be eligible to use MDMA in conjunction with therapy in MAPS-sponsored research studies. We have few therapist training opportunities available at this time while we focus on developing Phase 3 co-therapist teams. You can now subscribe to receive future training updates.
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
Social Anxiety in Autistic Adults: Final Participant Treated
On January 16, 2016, the 11th and final subject received their first treatment in our ongoing study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum. “We wish to express our gratitude for the feedback and guidance that the participants have offered generously at every step in the research process,” write researchers Charles Grob, M.D., and Alicia Danforth, Ph.D., in the Winter 2015 MAPS Bulletin article. “Their insights have helped the team learn how to work with autistic co-collaborators to explore ways in which MDMA-assisted therapy might bring relief for moderate to severe social anxiety.” 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. Learn more…
|$400,000estimated study cost||$13,000raised to date $15,000raised by partners||$372,000still needed||
Medical Marijuana Research
Marijuana for PTSD: DEA Inspects Johns Hopkins Trial Site
On January 14, 2016, officials from the local field office of the U.S. Drug Enforcement Administration (DEA) completed their inspection of the Johns Hopkins University trial site in Baltimore, Maryland, for our upcoming study of smoked marijuana for symptoms of PTSD in U.S. veterans. The DEA officials found no issues with the site. The protocol is now awaiting federal DEA approval. The study protocol will be cleared by the Institutional Review Board at Johns Hopkins upon DEA approval. This study is a multi-site Phase 2 drug development trial led by Coordinating Principal Investigator (PI) Marcel Bonn-Miller, Ph.D., with half of the 76 participants treated at the Johns Hopkins site led by Site PI Ryan Vandrey, Ph.D., and the other half treated at a site in Phoenix, Arizona, led by Site PI Sue Sisley, M.D. Renovations and construction at the Phoenix site are expected to be completed in February 2016, followed by DEA inspections. Once the DEA approves the study, we will be able to finalize the contact with the state of Colorado to receive funding, and then order the marijuana for the study from the National Institute on Drug Abuse (NIDA). Learn more…
|$2,156,000estimated study cost||$2,156,000grant awarded by the State of Colorado||Fundingcomplete||
Learn more about current and upcoming research at maps.org.
Host a Global Psychedelic Dinner This April
By hosting your own Global Psychedelic Dinner this April, you’ll join people around the world in gathering your community, hosting an open, personal conversation about psychedelics and psychedelic experiences, spreading the word, and helping raise $400,000 for MAPS’ purchase of one kilogram of pharmaceutical-grade (GMP) MDMA for our Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). In addition to raising funds for vital research, the Global Psychedelic Dinners are also an opportunity for you and your guests to share your stories about what psychedelics mean to you. You’ll be helping reduce stigma and enhance public understanding of the risks and beneficial uses of psychedelics. Register to host a Global Psychedelic Dinner and set up your online fundraising page to get started! Donate | Register to host a dinner…
January Giving Report: An Inspiring Start for 2016
In January 2016, over 240 supporters gave $48,240 to MAPS’ research and education programs. We send our gratitude to all those who generously supported MAPS last month:
- Anonymous ($10,000)
- Gale Hayman ($5,000)
- John Heilemann ($2,500)
- Giancarlo Canavesio ($2,000)
- Anonymous ($1,000)
- Anonymous ($1,000)
- Ingrid & Anthony Lombardino ($1,000)
- Sam Hummel, Jr. through the Hummel Family Fund ($1,000)
MDMA-Assisted Therapy for PTSD (Colorado)
- Anonymous ($10,000)
- Elizabeth Davis ($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.
Mother Jones, Military Times, Medium, and more…
Al Jazeera America
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
NEW Therapy with Substance by Dr. Friederike Meckel Fisher
Paperback | 224 pages | Muswell Hill Press, 2015
Dr. Friederike Meckel Fischer explores how the skillful use of psychedelic substances in psychotherapy can cause dramatic breakthroughs for people who have not responded to traditional methods of psychotherapy. Her extraordinary conclusion is that psycholytic psychotherapy has the capacity to reach the depth of the psyche required to resolve and heal our deepest wounds.
$24.95 | Now available
NEW Peyote: History, Tradition, Politics, and Conversations co-edited by Beatriz Caiuby Labate, Ph.D., and Clancy Cavnar, Ph.D.
Hardcover | 280 pages | Praeger, 2016
This new book explains the role that peyote—a hallucinogenic cactus—plays in the religious and spiritual fulfillment of certain peoples in the United States and Mexico, and examines pressing issues concerning the regulation and conservation of peyote as well as issues of indigenous and religious rights.
$60 | Now available
MAPS 30th Anniversary Banquet and Celebration: April 17, 2016, Oakland, CA
Join MAPS and the global psychedelic community on April 17, 2016, at the magnificent Scottish Rite Center in Oakland, California, celebrating three decades of advancements in psychedelic research and therapy. At this historic gathering, we’ll bring together key figures in the community to celebrate the progress we’ve made since MAPS’ founding in 1986.We’ll build the future of psychedelic medicine with a fundraiser to support MAPS’ $400,000 purchase of one kilogram of MDMA for clinical trials around the world, including MAPS’ Phase 3 studies to make MDMA-assisted psychotherapy a legal prescription treatment for posttraumatic stress disorder (PTSD).
The Banquet includes an exquisite buffet dinner, a virtuoso cello performance by Cello Joe, and addresses from
leading psychedelic researchers, participants in MAPS-sponsored research, forward-thinking philanthropists, acclaimed visionary artists Alex and Allyson Grey, and others. The Celebration begins after dinner with keynote address from MAPS Founder and Executive Director Rick Doblin, Ph.D., and continues into the night with a multimedia performance by internationally renowned artist Android Jones and Phadroid, a visual musical performance by DJ Spooky, and more to be announced. Sponsorships and group rates | Buy tickets now…
Women’s Visionary Congress New York Salon: March 11-13, 2016, New York City
The Women’s Visionary Congress will hold its first annual salon in New York City, entitled “Integrating Visionary Experiences.” The Salon will be preceded by a party on Friday, March 11, at the Rubin Museum. The Salon on Saturday, March 12, will feature presentations by research scientist Katherine MacLean, Ph.D., psychiatrist Julie Holland, M.D., and painter and social sculptor Allyson Grey. The Salon will be followed on the evening of Saturday, March 12, by a visionary storytelling gathering co-hosted by WVC and Psymposia. The salon will conclude on Sunday, March 13, with a tea party and immersive art experience in Central Park. People of all genders welcome. Learn more and register…
Global Ibogaine Conference: March 14-16, 2016, Tepoztlán, Mexico
The 2016 Global Ibogaine Conference will convene experts from around the world to discuss ibogaine therapy, the climate of global drug policy, and the sustainability and traditional uses of Tabernanthe iboga. Speakers will include MAPS-sponsored ibogaine researcher Thomas Kingsley Brown, Ph.D. Learn more and 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…
Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
Save the date! 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. Ticket sales, as well as opportunities to participate, will be announced soon. For past conference information, speaker videos, and more from Psychedelic Science 2013, visit psychedelicscience.org.
Natalie Ginsberg (MAPS) and Dr. Julie Holland (psychiatrist and author) at the “Drugs and Health: Perspectives from Experts at the Grassroots Level” panel of the interactive stakeholder consultation on February 10 in New York City.
MAPS Priorities for the United Nations General Assembly Special Session on Drugs
On February 10, 2016, Natalie Ginsberg (MAPS Policy and Advocacy Manager) and psychiatrist and author Julie Holland, M.D., participated in the interactive stakeholder consultation at the United Nations building in New York City, leading up to the upcoming United Nations General Assembly Special Session (UNGASS) on the World Drug Problem in April. MAPS has joined the UN Civil Society Task Force (CSTF) for the upcoming UNGASS. The CSTF will serve as the official liaison between the UN and the world community in preparation for UNGASS 2016. MAPS’ stated priorities regarding the UN are (1) Promoting policies with the goal of harm reduction rather than criminalization, including psychedelic harm reduction; (2) Ending worldwide research obstruction of cannabis, psychedelics and all substances, and promoting drug policies grounded in science; and (3) Decriminalization of personal drug use, and improved access to therapeutic
use of cannabis and psychedelic substances. Learn more…