MAPS Email Newsletter:
MDMA Study in Canada Ready to Begin;
US and Australian Veterans Call for More Research
September 17, 2013
VIDEO: Veterans and others talk to ABC (Australia) about growing support for MDMA-assisted psychotherapy for PTSD research in Australia.
Just a glimpse at the contents of the September 2013 edition of the Multidisciplinary Association for Psychedelic Studies (MAPS) Email Newsletter will tell you how quickly support is growing for careful research into the risks and benefits of psychedelics and marijuana. This month, I’m excited to bring you the most important updates from our ongoing international research and education programs, plus the latest headlines and multimedia from this fast-growing field.
Our Canadian study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) is ready to start after Health Canada approved the amended study protocol on September 6. After working for over five and a half years to start this study, we are now ready to start screening subjects and prepare for the first experimental treatment sessions.
In the past month, the U.S. Food and Drug Administration also approved changes to both of our ongoing studies of MDMA-assisted psychotherapy for PTSD in Colorado and South Carolina. The changes will make it easier to compare study results and help us design stronger Phase 3 studies, intended to make MDMA-assisted psychotherapy a legally available treatment for PTSD.
In this edition, you’ll also find:
- An amended protocol for our upcoming study of MDMA-assisted therapy for social anxiety in autistic adults is submitted for review
- Alternet showcases the Zendo Project psychedelic harm reduction services, and Popular Science looks at the future of medical marijuana research after CNN’s Dr. Sanjay Gupta admits that “sometimes marijuana is the only thing that works.”
- The Final Report is submitted from our completed Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced illness
- Upcoming conferences in Colorado, California, New York, and British Columbia host crucial conversations about psychedelics and marijuana in science, medicine, spirituality, and drug policy.
Join the conversation—connect with MAPS on YouTube, Facebook, Twitter, and Google+.
The MAPS Bulletin Summer 2013 Research Edition is now available online—check it out for a complete overview of MAPS’ international research and education programs. Donate just $40 or more for a subscription and we’ll send you your own copy to share with friends, family, and colleagues.
MAPS Director of Communications and Marketing
- Canada: Health Canada Accepts Protocol Changes; Study Prepares for Subject Screening
- Boulder: Second and Third Subjects Enrolled; IRB Approves Amended Protocol
- U.S. Veterans: 14th Subject Completes Experimental Sessions; IRB Approves Amended Protocol
- Switzerland: Researcher Claims Study Showed Large Treatment Effect, Not Small
- Amended Protocol Submitted to Institutional Review Board and State Advisory Panel
- Final Report Submitted to Swissmedic
- New Zealand: Ninth Subject Enrolled; Treatment Death Pauses Enrollment and Raises Safety Concerns
- How Do You Make Our Work Possible?
- Popular Science, ABC News, Australian Broadcasting Corporation, and more…
- Honor Thy Daughter: A Family’s Search for Hope and Healing by Marilyn Howell
- The Healing Journey: Pioneering Approaches to Psychedelic Therapy by Claudio Naranjo
- LSD: Problem Child and Wonder Drug Documentary DVD
- Horizons: Perspectives on Psychedelics: October 11-13, New York, NY
- National Bioneers Conference: October 18-20, San Rafael, CA
- International Drug Policy Reform Conference: October 23-26, Denver, CO
- Science and Nonduality Gathering: October 23-27, San Jose, CA
- Spirit Plant Medicine: October 26-27, Vancouver, Canada
Treating PTSD with MDMA-Assisted Therapy:
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults:
LSD-Assisted Therapy for Advanced Stage Illness Anxiety:
Ibogaine-Assisted Treatment for Addiction:
TREATING PTSD WITH MDMA-ASSISTED PSYCHOTHERAPY
Learn more about MDMA-assisted psychotherapy on or at mdmaptsd.org.
1. Canada: Health Canada Accepts Protocol Changes; Study Prepares for Subject Screening
Safety first: Getting ready for our new Canadian study.
On September 6, 2013, Health Canada approved the amended protocol for our new Canadian study of MDMA-assisted psychotherapy in 12 subjects with chronic, treatment-resistant PTSD! After working for over five and a half years to start this study, we can now start screening subjects after we finish setting up the study site. The protocol amendments included changes to dose levels (adding a 100 mg dose condition), the schedule of subject visits, and the timing of treatment outcome assessments. These changes will make it easier to compare results from this study with our other study sites around the world. The amended protocol was submitted to the U.S. Food and Drug Administration on August 20, and the initiation visit was conducted from August 22-24 by MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D. View the letter from Health Canada | Learn more…
$577,000 estimated study cost $16,000 raised $561,000 still needed
2. Boulder: Second and Third Subjects Enrolled; IRB Approves Amended Protocol
On August 12 and 29, 2013, the second and third subjects were enrolled in our ongoing study of MDMA-assisted psychotherapy for 12 subjects with PTSD in Boulder, Colorado. These subjects are both women suffering from chronic, treatment-resistant PTSD as a result of sexual abuse. All subjects will receive MDMA-assisted psychotherapy sessions from one of our therapist/intern teams. On August 13, the Institutional Review Board approved a series of changes to the study protocol, including adjustments to the dosing schedule and the addition of two safety measures. Unfortunately, recent flooding in Boulder has caused the treatment room ceiling to collapse, delaying the first experimental treatment sessions. Learn more…
$480,000 estimated study cost $190,000 raised $289,000 still needed
3. U.S. Veterans: 14th Subject Completes Experimental Sessions; IRB Approves Amended Protocol
Iraq War veteran Tony Macie talks about his experience as a participant in our ongoing study of MDMA-assisted psychotherapy for PTSD.
On September 12, 2013, the 15th subject was enrolled in our ongoing study of MDMA-assisted psychotherapy for 24 U.S. veterans, firefighters, and p
olice officers with service-related PTSD. The 14th subject received their second experimental session on August 9, and their third and final session on September 13. On August 28, the Institutional Review Board approved several changes to the study protocol. These amendments included changes to dosing strategy (adding a 100 mg dose), adjustments in visit schedules, and additional treatment outcome and safety measures. Learn more…
$1,380,000 estimated study cost $875,000 raised $505,000 still needed
4. Switzerland: Researcher Claims Study Showed Large Treatment Effect, Not Small
On August 27, 2013, the Journal of Psychopharmocology published a Letter to the Editor arguing that our completed Swiss study of MDMA-assisted psychotherapy for PTSD had a large effect size not previously reported in the January 2013 publication of the results in the same journal. In the unsolicited yet most welcome letter, “MDMA-assisted psychotherapy found to have a large effect for post-traumatic stress disorder,” researcher Henri Chabrol of the University of Toulouse, France, explains why our traditional statistical method should have been supplemented by an effect size calculation, and that in fact subjects showed “on average, a substantial improvement in PTSD symptoms over the course of MDMA-assisted psychotherapy.” Receiving this unsolicited positive feedback on our results from an independent expert highlights both the importance of international collaboration in psychedelic research and the sincere caution with which we report our results. View the letter | Download the original paper | Learn more…
This study is complete and has been fully funded
MDMA-ASSISTED THERAPY FOR SOCIAL ANXIETY IN AUTISTIC ADULTS
5. Amended Protocol Submitted to Institutional Review Board and State Advisory Panel
On August 2, 2013, an amended protocol for our upcoming study of MDMA-assisted therapy for social anxiety in autistic adults was submitted to the Institutional Review Board at Harbor-UCLA/Los Angeles Biomedical Research Institute. The IRB review is scheduled to take place on September 25. On August 19, the study protocol and related documents were submitted to the Research Advisory Panel of California (RAPC), formerly the California Research Advisory Panel (CRAP), an additional approval required for research with Schedule I drugs only in California. The RAPC review is scheduled for September 18. Once the IRB and RAPC approve the amended protocol, Principal Investigator Charles Grob, M.D., will apply for a Schedule I license from the Drug Enforcement Administration. Dr. Grob previously held a license for MDMA in the early 1990s when he conducted our first Phase 1 MDMA safety study, and also has a current license for psilocybin for his Heffter Research Institute-sponsored study of psilocybin for anxiety associated with cancer, so we anticipate the DEA will approve his application. Learn more…
$259,000 estimated study cost $1,000 raised $258,000 still needed
LSD-ASSISTED PSYCHOTHERAPY FOR ADVANCED STAGE ILLNESS ANXIETY
Peter Gasser, M.D., shares the results of our completed Swiss study of LSD-assisted psychotherapy at Psychedelic Science 2013.
6. Final Report Submitted to Swissmedic
On September 17, 2013, the Final Report for our completed Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced stage illness was submitted to Swissmedic. The report contains information about the study protocol, how the study was conducted, and all data in both raw and analyzed formats. This report is required under International Council on Harmonization/Good Clinical Practice (ICH/GCP) as well as FDA regulations. View the report | Learn more…
This study is complete and has been fully funded
IBOGAINE-ASSISTED TREATMENT FOR ADDICTION
7. New Zealand: Ninth Subject Enrolled; Treatment Death Pauses Enrollment and Raises Safety Concerns
On August 23, 2013, the ninth subject was enrolled in our ongoing observational study of ibogaine-assisted treatment for opioid dependence in New Zealand. In this study, Principal Investigator Geoff Noller, Ph.D., is collecting follow-up data from subjects undergoing treatment at an independent ibogaine center in New Zealand. Dr. Noller was previously collecting data from two treatment centers, but one of these centers has now closed due to a recent death in treatment at a time when the patient was not under medical supervision. The death has raised significant concerns in the New Zealand ibogaine treatment community, and emphasizes the importance of establishing clear treatment protocols, which were not followed
at the facility where the death took place. Treatments were halted at both facilities after the death but have resumed at the facility with a continued record of no significant health issues and where patients are continually monitored. Dr. Noller reported that he felt “very confident” in the remaining provider’s practice and anticipates that the study is likely to be completed in Spring 2015. Learn more… Donations are needed to support ibogaine research
Download one of our brochures.
8. How Do You Make Our Work Possible?
Over the past month, 23 donors gave $52,890 to support MAPS’ research, education, and harm reduction programs. We would especially like to thank David Bronner for his $25,000 quarterly gift for general support; an anonymous donor for their gift of $5,000 for our ongoing MDMA-assisted psychotherapy study in Boulder, Colorado; Julie Holland for her gift of $1,299 for our medical marijuana research fund; and Taylor James for his $1,000 in general support. We also gratefully acknowledge the Rockefeller Brothers Fund, who made a grant of $10,000 to honor Richard Rockefeller and his commitment to philanthropy, or “love of humanity.” Our appreciation also goes to the 18 donors who gave between $1 and $1,000 dollars in the past month. In addition, our Fiscal Sponsorship Program processed $4,000 in gifts to the Temple of Whollyness at Burning Man 2013, and $526 for online forum Bluelight.ru. Many of our current donors choose to give monthly by signing up with a credit card. To join our monthly donors and provide sustaining support, just visit maps.org/donate and choose “Monthly” from the drop down list. Thank you for making our work possible!
Help us make psychedelics and marijuana into prescription medicines—donate today!
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
9. Popular Science, ABC News, Australian Broadcasting Corporation, and more…
Australian Broadcasting Corporation: Push to Trial Use of Ecstasy in Post-Traumatic Stress Disorder Treatment | view
Conor Duffy | August 30, 2013
The Conversation: Shroom to Grow: Australia’s Missing Psychedelic Science | view
Stephen Bright & Martin Williams | August 29, 2013
Popular Science: Sanjay Gupta: Only 6 Percent Of Marijuana Research Considers Medical Benefits | view
Shaunacy Ferro | August 12, 2013
ScienceDaily: LSD and Other Psychedelics Not Linked With Mental Health Problems | view
ScienceDaily | August 19, 2013
New Scientist: Mind-Altering Drug Could Offer Life Free of Heroin | view
New Scientist | August 22, 2013
News21: Veterans Try Alternative Treatments from Yoga to Marijuana | view
Bonnie Campo & Jake Stein | September 9, 2013
ABC News: A Music Festival Where Drugs Aren’t the Enemy | view
| September 6, 2013
Alternet: Making Psychedelic Trips Safe, Even at Burning Man | view
April Short | August 9, 2013
TIME.com: Four Myths About the Drug Molly | view
Maia Szalavitz | September 3, 2013
All proceeds from the MAPS Store support psychedelic and medical marijuana research and education.
10. Honor Thy Daughter: A Family’s Search for Hope and Healing by Marilyn Howell
Honor Thy Daughter: A Family’s Search for Hope and Healing
by Marilyn Howell
208 pages | Published by MAPS
This is a true story by Marilyn Howell, Ed.D., about her family’s search for physical, emotional, and spiritual healing as her daughter struggles with terminal cancer. The family’s journey takes them through the darkest corners of corporate medicine, the jungles of Brazil, the pallid hallways of countless hospitals, and ultimately into the hands of an anonymous therapist who offers the family hope and healing through MDMA-assisted psychotherapy. In this poignant book Howell shares with us how psychedelic therapy helped heal the bonds ripped apart by illness.
$16.95 | Now available
11. The Healing Journey: Pioneering Approaches to Psychedelic Therapy by Claudio Naranjo
The Healing Journey: Pioneering Approaches to Psychedelic Therapy
by Claudio Naranjo, M.D.
221 pages | Published by MAPS
Second Edition with a new Foreword by Rick Doblin, Ph.D.
“In this remarkable book, Chilean-American psychiatrist Claudio Naranjo takes us on a scientific adventure through his groundbreaking research into new experiential methods of psychotherapy facilitated by psychedelic substances. The Healing Journey reveals these consciousness-expanding compounds to be fascinating therapeutic tools that are now—40 years after the original publication—gaining wider recognition in Western clinical and academic circles.”
$16.95 | Now available
12. LSD: Problem Child and Wonder Drug Documentary DVD
LSD: Problem Child and Wonder Drug Documentary DVD/em>
60 minutes | Released 2009
LSD: Problem Child and Wonder Drug captures the fascinating story of LSD as eloquently told by LSD discoverer Albert Hofmann. With interviews and presentations by Rick Doblin, Alex Grey, Ralph Metzner, Carl Ruck, Goa Gil, and others, this historic message from the father of LSD is a timeless relic and an immediate source of inspiration.
$25.00 | Now available
See our Events Calendar for more!
13. Horizons: Perspectives on Psychedelics: October 11-13, New York, NY
Horizons is a conference about psychedelics that is held annually in New York City at Judson Memorial Church. Its goal is to open a fresh dialogue on psychedelics’ role in medicine, culture, history, spirituality, and creativity. This will be the 7th annual Horizons conference. MAPS Harm Reduction Coordinator Linnae Ponté will give an update on our harm reduction and research initiatives, and Boulder, Colorado therapist and researcher Marcela Ot’alora will discuss our ongoing studies of MDMA-assisted psychotherapy for PTSD.
14. National Bioneers Conference: October 18-20, San Rafael, CA
Includes a panel on “The Healing Potential of Cannabidiol, MDMA, and Entheogens” with Martin Lee (author, Smoke Signals and Acid Dreams), Amy Emerson (MAPS Director of Clinical Research), and Ralph Metzner (psychedelic researcher). Moderated by J.P. Harpignies (Bioneers associate producer). MAPS supporters can also receive a 20% discount on conference registration by using code BIOCON13 if you register before September 30.
15. International Drug Policy Reform Conference: October 23-26, Denver, CO
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. Reform 2013 will include an entire track dedicated to psychedelics in science, medicine, policy, and international harm reduction.
16. Science and Nonduality Gathering: October 23-27, San Jose, CA
The fifth Science and Nonduality (SAND) Gathering will take place in the Dolce Hayes Mansion in San Jose, CA. This biannual event in the US and Europe brings together 700 participants from all over the world. Over 60 preeminent scientists, philosophers, authors, and spiritual teachers gather with us to explore a new understanding of who we are, both as individuals and as a society.
17. Spirit Plant Medicine: October 26-27, Vancouver, Canada
The third annual Spirit Plant Medicine Conference (SPMC) intends to offer accurate, respectful, and beneficial information and inspiration on the healing and spiritual use and broader context of ayahuasca, psilocybin mushrooms, peyote, iboga, cannabis, and other sacred plants. Spirit Plant Medicine 2013 will include a MAPS Canada information and exhibit booth.
Looking for more ways to get involved? Check out our Student Resources page!