MAPS Bulletin Summer 2015 Vol. 25, No. 2 – Research Edition
Treating PTSD with MDMA-Assisted Therapy
Final Experimental Session Complete in Veterans Study; Preliminary Results Presented (Ongoing study)
Location: Charleston, South Carolina
Principal Investigator: Michael Mithoefer, M.D., with
co-therapist Annie Mithoefer, B.S.N.
Estimated study budget: $1,428,000
Already raised: $1,386,000
Needed to complete this study: $42,000
On July 31, 2015, the final experimental session took place in our ongoing study of MDMA-assisted psychotherapy for 24 U.S. veterans, firefighters, and police officers with treatment-resistant PTSD. "We had our last experimental session today," reports Principal Investigator Michael Mithoefer, M.D. "It was, once again, a wonderful example of the power of MDMA-assisted therapy to bring healing, and to change the lives of people who have been suffering for years with PTSD." The first subject was enrolled in November 2010.
Principal Investigator Michael Mithoefer, M.D., shared preliminary results and ongoing research into MDMA-assisted psychotherapy for PTSD at the American Psychiatric Association Annual Meeting in Toronto, Canada, from May 16–20, where MAPS hosted an educational booth in the exhibit hall (see full report on page 8).
Approximately half of the 24 subjects have also enrolled in our ongoing sub-study, in collaboration with researchers at the Medical University of South Carolina (MUSC), of the physiological effects of MDMA-assisted psychotherapy. This sub-study is using heart rate variability (HRV) and functional magnetic resonance imaging (fMRI) to explore correlations with clinical outcomes.
We anticipate that the results will be published in early 2016, after the data from this study and all of our other international Phase 2 pilot studies is submitted to the U.S. Food and Drug Administration for consideration of Breakthrough Therapy status.
Goals for this study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted psychotherapy in people suffering from war-related trauma; (2) comparing the effectiveness of the treatment for people with war-related trauma versus for people with trauma related to sexual abuse, assault, and other causes; (2) comparing different doses of MDMA for therapeutic effectiveness and ability to create a successful double-blind; and (3) increasing awareness and support for our work by assisting a population with mainstream public recognition.
Subject 19 Treated in Boulder Study; Subjects Interviewed in Marie Claire (Ongoing study)
Location: Boulder, Colorado
Principal Investigator: Marcela Ot’alora, M.A., L.P.C.
Estimated study budget: $771,000
Already raised: $716,000
Needed to complete this study: $55,000
On July 17, 2015, subject 19 out of 23 was treated in our ongoing study of MDMA-assisted psychotherapy for subjects with PTSD from sexual assault, violent crime, war, natural disasters, or any other cause, taking place in Boulder, Colorado. In addition to obtaining Phase 2 data on the safety and effectiveness of MDMA-assisted psychotherapy for PTSD, this study is also comparing outcomes between different combinations of male/female co-therapist teams. We expect that the final subject will be treated in October 2015. Primary outcome data is anticipated to be available in December 2015, and the final results prepared for publication in late 2016.
Two subjects from this study spoke about their experience in an in-depth feature article in the September 2015 issue of Marie Claire. "I was really in a fight for my life," says study subject Brenda Murphy. "The fear of the stigma associated with using MDMA [in the study] was far less than the fear of continuing to feel the PTSD symptoms for the rest of my life."
On March 25, a study participant participated in a public "Ask Me Anything" session on reddit, answering over 120 questions about her experience. "It wasn’t only the MDMA, I can’t stress that enough," she explains. "My therapists were incredible. They’re knowledgeable, thoughtful, insightful people who helped me save my life."
Goals for this study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted psychotherapy for subjects with PTSD from a variety of causes, (2) comparing different doses of MDMA for therapeutic effectiveness and ability to create a successful double-blind, (3) exploring whether using intern co-therapists can reduce costs while maintaining treatment effectiveness, and (4) training the next generation of psychedelic psychotherapists.
Fifth Subject Treated, Three More Enrolled in Israeli Study (Ongoing study)
Location: Beer Yaakov, Israel
Clinical Investigator: Moshe Kotler, M.D.
Estimated study budget: $509,000
Already raised: $87,000
Needed to complete this study: $422,000
On July 14, 2015, the fifth subject was treated in our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD. The seventh subject was enrolled on July 23, and the eighth and ninth subjects were enrolled on August 1. 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. "We are excited about the recent enrollments in our ongoing Israeli study, where we are getting promising results in a population with endemic trauma," reports MAPS Clinical Research Scientist Berra Yazar-Klosinski, Ph.D. This study is actively seeking Israeli participants (learn more at maps.org/israel).
Goals for this study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted psychotherapy for subjects with PTSD mostly related to war and terrorism, (2) comparing different doses of MDMA for therapeutic effectiveness and ability to create a successful double-blind, (3) working in direct association with the Israeli Ministry of Health, and (4) exploring the use of MDMA-assisted psychotherapy in other cultural contexts.
Fifth and Sixth Subjects Treated in Canadian Study (Ongoing study)
Location: Vancouver, British Columbia, Canada
Principal Investigators: Ingrid Pacey, M.D.
Estimated study budget: $470,000
Already raised: $46,000 + $69,000 raised by partners
Needed to complete this study: $355,000
On June 26 and July 3, 2015, the fifth and sixth subjects were treated in our ongoing Canadian study of MDMA-assisted psychotherapy for PTSD. The sixth subject was enrolled on June 29. Led by Principal Investigator Ingrid Pacey, M.D., in Vancouver, B.C., this Phase 2 study is treating up to 12 subjects with chronic, treatment-resistant PTSD from sexual
assault, violent crime, military service, or any other cause.
Mark Haden, Chair of the Board of Directors of MAPS Canada, reflected on the media attention the study has been receiving: "We had 15 minutes on CBC national radio, a feature article in Maclean’s (Canada’s most prominent weekly magazine), and CBC’s high-profile show "Ideas" is producing two new shows dedicated to psychedelics," Haden writes. "MAPS Canada is not just developing a better treatment for PTSD, but also having an impact on public perception of the vast potential of psychedelic medicine."
Goals for this study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted psychotherapy for subjects with PTSD from a highly skilled co-therapist team, (2) comparing different doses of MDMA for therapeutic effectiveness and ability to create a successful double-blind, and (3) initiating the first Canadian research into the potential benefits of psychedelic psychotherapy in over 40 years.
Five-Day MDMA-Assisted Therapy Training Held in UK (Training Program)
Location: Charleston, South Carolina
Principal Investigator: Michael Mithoefer, M.D., with
co-therapist Annie Mithoefer, B.S.N.
In December 2014, MAPS held a five-day training in Buckinghamshire, UK, for researchers who will be involved in upcoming clinical studies of the therapeutic use of MDMA. The training included 30 neuroscientists, psychiatrists, psychologists, social workers, and others from Australia, Brazil, Germany, Portugal, Spain, Switzerland, and the United States. The training was primarily organized for the Cardiff University team that will be conducting an upcoming fMRI study of the acute effects of MDMA on the brains of UK veterans with PTSD (study funded by MAPS, the Beckley Foundation, and Anton Bilton). The purpose of the training was to provide researchers with the knowledge needed to conduct future studies of MDMA-assisted therapies for PTSD, couples counseling, life-threatening illness anxiety, and hospice care; and to develop a model for training the many new therapists who will be needed for our Phase 3 studies of MDMA-assisted psychotherapy for PTSD. The training was led by Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., at the gorgeous Tyringham Hall, the use of which was generously donated by Anton Bilton. "Beyond the important therapeutic training we’re all so passionate about, living together for five days has really created a sense of a community," reported MAPS Research and Advocacy Manager Natalie Ginsberg. "Everyone here believes so deeply in the work and it’s been really special having researchers with such different backgrounds engaging in conversation."
Are you interested in learning more about being a Phase 3 MDMA-assisted psychotherapy for PTSD researcher? Contact us at askMAPS@maps.org.
MAPS and UK Researchers Plan Brain Imaging Study of MDMA and PTSD (Upcoming study)
Location: Cardiff University, UK
Principal Investigator: Prof. Jon Bisson
Study Lead: Ben Sessa, M.D.
Funded in part by MAPS.
"Hooking up with the neuroimaging expertise of Robin Carhart-Harris, Ph.D., and Dr. David Nutt at Imperial College London and Richard Wises’ fMRI department at Cardiff University, we designed a study that looks primarily at the neurobiological mechanisms behind MDMA’s effects on the core features of PTSD. There have already been neuroimaging studies on patients with PTSD and on healthy people taking MDMA, but ours will be the first time fMRI has looked specifically at patients with PTSD under the direct effect of MDMA. This study will be funded by MAPS, Beckley Foundation, and an anonymous donor. There is no therapeutic component to the study, but subjects will be able to request therapeutic support if they feel it is necessary since for most of their MDMA experience they will not be in the scanner. This study will also explore MDMA’s potential beneficial effects without delivering formal therapy." —Dr. Ben Sessa MBBS (MD) BSc MRCPsych, Consultant Child and Adolescent Psychiatrist in Substance Misuse and Psychedelic Researcher, Bristol and Cardiff, UK.
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
Eighth Subject Treated; Site Passes Routine DEA Inspection (Ongoing study)
Location: Los Angeles, California
Principal Investigators: Charles Grob, M.D., and
Alicia Danforth, Ph.D.
Estimated study budget: $336,000
Already raised: $12,715 raised + $15,000 raised by partners
Needed to complete this study: $308,285
On July 25, 2015, the eighth subject was treated in our ongoing study of MDMA-assisted therapy for social anxiety in 12 adults on the autism spectrum. As of July 30, five subjects have completed their six-month follow-up visit. This study is exploring whether MDMA combined with therapy can enhance functional skills and quality of life in autistic adults with social anxiety. Sponsored by MAPS, this is a collaborative study between MAPS, the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, and researchers at Stanford University.
On July 2, the study site passed a routine inspection by the U.S. Drug Enforcement Administration (DEA). "The DEA visit was a routine inspection, and the process went quite smoothly," reports Principal Investigator Charles Grob, M.D. "Recruitment is going well, and we are looking forward to conducting several treatment sessions over the next month."
In May 2015, MAPS participated in Silicon Valley Gives Day, in which 100 donors contributed $11,715 for MDMA biomarker research at Stanford University in association with this study, where researchers will analyze blood plasma concentrations of several hormones hypothesized to be involved in the therapeutic effectiveness of MDMA when combined with therapy. "The interesting thing about MDMA and similar drugs…is that they do have multi-targeted approaches," says Stanford University researcher Dean Carson, Ph.D. "We’re talking about the effects of serotonin, dopamine, oxytocin, cortisol, vasopressin…It’s really a systems-level approach that I think is very important in the treatment of psychiatric disorders."
Goals for this study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted therapy for autistic adults diagnosed with social anxiety, (2) determining if additional studies in this area are warranted, and (3) initiating a new program of research into a possible beneficial use of MDMA building on collected case accounts.
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Study Initiated; First Two Subjects Treated;Four Enrolled (Ongoing study)
Location: Marin, California
Principal Investigators: Phil Wolfson, M.D.
Estimated study budget: $608,000
Already raised: $187,000
Needed to complete this study: $421,000
On July 2 and July 6, 2015, the first two subjects were treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. The fourth subject was enrolled on June 18. 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. "I feel absolutely honored to be meeting and working with our first participants," writes co-therapist Julane Andries. "As they share their stories, and the physical and emotional pain they have endured, I am most impressed with their drive to seek help to be free from the fear, the anxiety, and depression that can come as one lives with life threatening illness."
On Sunday, May 24,
the San Francisco Chronicle published a front-page article by journalist Don Lattin about the study highlighting increased public support for psychedelic therapy research. "It’s a really interesting and a very powerful new approach," Dr. Thomas Insel, director of the National Institute of Mental Health, told the Chronicle. "It’s not just taking MDMA. It’s taking it in the context of a treatment that involves improved insight and increased skills and using this in the broader context of psychotherapy."
Goals for this study include (1) gathering data on the safety and effectiveness of MDMA-assisted psychotherapy for subjects with anxiety associated with life-threatening illness; (2) determining if additional studies are warranted; and (3) initiating MDMA-assisted psychotherapy research for a new clinical indication.
LSD-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Switzerland: Qualitative Results Published, Showing Lasting Benefits (Study completed)
Location: Solothurn, Switzerland
Principal Investigator: Peter Gasser, M.D.
This study is complete and has been fully funded.
On November 11, 2014, the peer-reviewed Journal of Psychopharmacology published a paper describing the results of a qualitative study of subjects in our completed Swiss Phase 2 pilot study of LSD-assisted psychotherapy for 12 subjects with anxiety associated with advanced-stage illness. A March 2014 paper in the Journal of Mental and Nervous Disease about our completed pilot study found positive trends in the reduction of anxiety following two LSD-assisted psychotherapy sessions, and indicated that LSD-assisted psychotherapy can be safely administered in these subjects. The long-term results, showed lasting reductions in anxiety and increases in quality life for participants one year after receiving two LSD-assisted psychotherapy sessions. This was the first study of the therapeutic use of LSD in humans in over 40 years.
Goals for this study were (1) gathering evidence for the safety and effectiveness of LSD-assisted psychotherapy for subjects with anxiety related to advanced-stage illness, and (2) completing the first study of LSD humans in over 40 years.
Ibogaine-Assisted Therapy for Drug Addiction
Final Subject Enrolled in New Zealand Ibogaine Study (Ongoing study)
Location: New Zealand
Principal Investigator: Geoff Noller, Ph.D.
Donations are needed to support ibogaine research.
Investigator Geoff Noller, Ph.D., has collected follow-up data from subjects undergoing treatment at an independent ibogaine center in New Zealand. Data from this study will be compared to the results of our completed observational study in Mexico.
Goals for this study include (1) gathering preliminary evidence about the safety and potential benefits of ibogaine-assisted therapy for opiate addiction, (2) supplementing the data from our completed observational ibogaine study in Mexico, and (3) initiating and encouraging psychedelic research in New Zealand.
Data Entry Completed in Mexico Ibogaine Study (Study completed)
Location: Mexico
Principal Investigator: Thomas Kingsley Brown, Ph.D.
This study is complete and has been fully funded.
The results of our completed study of ibogaine-assisted therapy for addiction in Mexico are being prepared for publication in a peer-reviewed scientific journal. In this study, Principal Investigator Thomas Kingsley Brown, Ph.D., observed the long-term effects of ibogaine treatment for individuals undergoing treatment for opioid dependence at an independent clinic in Mexico.
Medical Marijuana Research
Johns Hopkins IRB Conditionally Approves Study; NIDA Provides Marijuana Cost/Availability Information (Study in development)
Location: Baltimore, Md., and Phoenix, Ariz.
Coordinating Principal Investigator: Marcel Bonn-Miller, Ph.D. (University of Pennsylvania)
Co-Investigators/Site Principal Investigators: Sue Sisley, M.D. (private practice) and Ryan Vandrey, Ph.D. (Johns Hopkins University)
Co-Investigator: Paula Riggs, M.D. (University of Colorado)
Estimated study budget: $2,156,000
Already raised: $2,156,000 grant awarded by the State of Colorado
On August 18, 2015, the Institutional Review Board (IRB) at Johns Hopkins University granted conditional approval of the protocol for our planned study of smoked marijuana for symptoms of PTSD in 76 U.S. veterans. The conditional approval required the addition of several safety-related revisions, which we have accepted. We have also requested that the FDA remove the clinical hold which was placed on the study pending the Johns Hopkins IRB approval.
On March 31, the National Institute on Drug Abuse (NIDA) provided MAPS with information about the cost and availability of marijuana for the study. It took over a year for NIDA to provide this information after MAPS received our first approval from the U.S. Department of Health and Human Services to purchase marijuana from NIDA in March 2014. Currently, NIDA has three of the four varieties of marijuana we requested; we have asked whether they will also be able to provide an additional variety with a balanced THC/CBD ratio and higher concentrations of THC and CBD than NIDA currently lists as available.
On March 11, the Institutional Review Board at the University of Pennsylvania, where Coordinating Principal Investigator (PI) Marcel Bonn-Miller, Ph.D., is located, approved the study protocol. On March 17, an Independent Review Board approved the study for the Arizona site. Dr. Sisley will apply for her Schedule I license from the Drug Enforcement Administration once we find a suitable Arizona location. Once all approvals are received and the study initiation visits are conducted, the study will be cleared to proceed.
On February 25, 2015, in a letter dated February 11, the U.S. Public Health Service (PHS) cleared the revised study protocol. The first historic approval from PHS for the study came in March 2014. The protocol was amended for our successful grant to the Colorado Department of Public Health and Environment, which awarded more than $2.1 million to MAPS for the study. The revised protocol includes an additional research site at Johns Hopkins University led by Co-Investigator/Site Principal Investigator (PI) Ryan Vandrey, Ph.D.; a private practice site for Co-Investigator/Site PI Sue Sisley, M.D.; the addition of Marcel O. Bonn-Miller, Ph.D., as Coordinating PI; and the addition of Co-Investigator Paula Riggs, M.D., to help ensure scientific integrity for the study.
Obama Administration Eliminates PHS Review for Marijuana Research
On June 22, 2015, the U.S. Department of Health and Human Services (HHS) announced that it had eliminated the redundant Public Health Service (PHS) review process for federally regulated marijuana research, removing a significant barrier to privately funded medical marijuana research. The Department acknowledged that "HHS is aware that this committee review is perceived to be an obstacle to non-federally funded research…The department expects the action announced will help facilitate further research."
Since 1999, researchers seeking to study marijuana needed to obtain permission from PHS to purchase marijuana from the National Institute on Drug Abuse (NIDA), which maintains a monopoly on the supply of marijuana for research in the U.S. Now, researchers with Food and Drug Administration (FDA) clearance can request marijuana directly from NIDA without the additional PHS review process. MAPS is now working with Prof. Lyle Craker to prepare a new request asking the U.S. Drug Enforcement Administration (DEA) for permission to further open doors for medical mariju
ana research by opening a growing facility at the University of Massachusetts-Amherst.
"We’re hoping the overall political environment has shifted enough where we will actually get permission from the DEA to start this farm and then we won’t have to go through NIDA at all," Brad Burge of MAPS told U.S. News and World Report. "It’s a great opportunity for the Obama administration to show it’s progressive on marijuana issues. We’re pretty hopeful."