Summer 2014: Vol. 24 No. 2 Research Edition
Treating PTSD with MDMA-Assisted Therapy
19 of 24 Subjects Treated in Veterans Study; Legalizing Psychedelic Therapy Campaign Seeks to Complete Funding
Location: Charleston, South Carolina
Principal Investigator: Michael Mithoefer, M.D., with co-therapist Annie Mithoefer, B.S.N.
Estimated study budget: $1,380,000 Already raised: $1,330,000
Needed to complete this study: $50,000
On June 17, 2014, the 19th subject began treatment in our ongoing study of MDMA-assisted psychotherapy for 24 U.S. veterans, firefighters, and police officers with service-related PTSD, led by Principal Investigator Michael Mithoefer. On May 23, 2014, the 18th subject was treated and on May 7, the 11th subject completed their one-year follow-up evaluation. Six subjects have also enrolled in our new sub-study of the physiological effects of MDMA-assisted psychotherapy, which will examine heart rate variability (HRV) and functional magnetic resonance imaging (fMRI) and explore correlations with clinical outcomes. Virgil Houston, and Iraq veteran who participated in the study, wrote to MAPS after completing the study. “As a patient who has a bit of survivor’s guilt since I know many others who need this treatment as badly as I did, I have trouble accepting 2021 as the earliest date this can become widely available. Maybe you guys are the realistic ones, but keeping this away from people until then just doesn’t pass the logic test.”
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.
Four More Subjects Treated in Boulder Study; Study Size Increased to 23 Subjects
Location: Boulder, Colorado
Clinical Investigator: Marcela Ot’alora, M.A., L.P.C.
Estimated study budget: $711,000
Already raised: $213,000
Needed to complete this study: $498,000
From June 20-24, 2014, the sixth, seventh, and eighth subjects were treated in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. One subject voluntarily withdrew from the study following their first experimental session on May 2. Led by Clinical Investigator Marcela Ot’alora, this study is exploring the safety and effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern being trained in therapy, social work, or nursing. Our application to increase the study size from 17 to 23 subjects with PTSD due to sexual assault, military combat, or other causes was approved by the Institutional Review Board on May 6, and passed the Food and Drug Administration’s 30-day review period on June 1. We have increased the size of this study in order to get a better sense of the range of outcomes from different co-therapist teams—important data for calculating the size of our Phase 3 studies—and to compare the effectiveness of different doses of MDMA combined with psychotherapy for treating PTSD. “I feel so blessed to have been in this study,” reported one female participant in an email. “I feel like I have access to much more of myself and the part of me that is healthy has become stronger.”
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.
Fourth Subject Treated in Israeli Study
Location: Beer Yaakov, Israel
Clinical Investigator: Moshe Kotler, M.D.
Estimated study budget: $493,000
Already raised: $83,000
Needed to complete this study: $410,000
On June 15, 2014, the fourth subject was treated in our ongoing Israeli study of MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD. This study will enroll 10 subjects, some of whom will be soldiers with war-related PTSD referred by the Israeli Defense Forces. Led by Clinical Investigator Moshe Kotler, M.D., this study is taking place at Beer Yaakov Mental Hospital. Recent and ongoing violence in Israel has called renewed attention to the importance of conducting research for PTSD in Israel. In an email to MAPS Executive Director Rick Doblin, Ph.D., Israeli study coordinator Dafna Bornstein-Lavi reported, “Again I’m under the table in Beer Yaakov with missiles flying over my head.”
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.
Canadian Study: IRB Approves Protocol Amendments, MAPS Canada Receives Charity Status
Study screening subjects
Location: Vancouver, British Columbia, Canada
Principal Investigators: Ingrid Pacey, M.D., and Andrew Feldmár
Estimated study budget: $419,000
Already raised: $44,000 raised + $3,500 raised by partners
Needed to complete this study: $371,500
From August 1–5, 2014, Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., led a two-and-a-half day training in Vancouver, BC, for the newly added co-investigators in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD, Donna Dryer, M.D., and Richard Yensen, Ph.D. Also participating in the training were Phil Wolfson, M.D., Julane Andries, Cody Swift, Linnae Ponté, and Shannon Petitt who will each be co-conducting experimental sessions in our up- coming study of MDMA-assisted psychotherapy for anxiety associated with advanced-stage illness. On July 22, MAPS Director of Clinical Research Amy Emerson and Clinical Re- search Scientist Berra Yazar-Klosinski, Ph.D., conducted the study initiation visit via remote teleconference to prepare study staff and trial documentation to begin screening and enroll- ing subjects. An amended protocol, which includes changes to the MDMA dose condition, was approved by the Institutional Review Board and submitted to Health Canada for review on February 14, and to the U.S. Food and Drug Administration on February 6. MAPS is sponsoring this study in association with MAPS Canada, the first and only Canadian organization dedi- cated to psychedelic research and education, now able to receive tax-deductible contributions in Canada. Canadian citizens can make a
tax-deductible donation to MAPS Canada by sending a check made out to MAPS Canada to MAPS Canada, c/o Mark Haden, 3155 W. 6th Avenue,Vancouver, BC V6K 1X5.
Therapists Receive MDMA-Assisted Therapy in Training Protocol
Location: Charleston, South Carolina
Principal Investigator: Michael Mithoefer, M.D., with co-therapist Annie Mithoefer, B.S.N.
Estimated study budget: $472,000 Already raised: $34,000
Needed to complete this study: $418,000
Between March 24 and April 4, 2014, four additional subjects received MDMA-assisted psychotherapy in our ongoing therapist training study in Charleston, SC. This protocol was designed as a Phase 1 study of the safety and psychological effects of MDMA-assisted psychotherapy in healthy volunteers, with subjects limited to therapists in training to work on a MAPS-sponsored MDMA-assisted psychotherapy study. Two of the subjects enrolled are therapists in our ongoing study in Boulder, Colorado, and two are affiliates of the U.S. Veterans Affairs National Center for PTSD Research training for a possible collaborative VA/MAPS study, with funding offered from MAPS. During these sessions, an additional night attendant affiliated with the VA was also trained.
Goals for this study include (1) providing therapists with direct experience of MDMA when taken in a therapeutic context to enhance their ability to conduct effective MDMA-assisted psychotherapy, and (2) collecting additional data on the safety of MDMA-assisted psychotherapy in healthy volunteers taking MDMA in a therapeutic context.
UK Brain Imaging Study to Explore MDMA’s Effects on PTSD without Therapy
Location: Cardiff University, UK
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 Uni- versity, we designed a study that looks primarily at the neuro- biological mechanisms behind MDMA’s effects on the core fea- tures 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 experi- ence 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, Con- sultant Child and Adolescent Psychiatrist in Substance Misuse and Psychedelic Researcher, Bristol and Cardiff, UK.
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
First Three Subjects Enrolled ; New Website Launched
Location: Los Angeles, California
Principal Investigators: Charles Grob, M.D., and Alicia Danforth, Ph.D.
Estimated study budget: $452,000
Already raised: $1,000 raised + $15,000 raised by partners
Needed to complete this study: $418,000
On July 18, 2014, the third subject was enrolled in our new study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum.The first and second subjects were enrolled on May 17 and June 20, respectively. The first treatments are scheduled to take place in August. On March 26, we officially launched mdma-autism.org, with background on the goals of the study, plus educational resources about autism, social anxiety, and MDMA-assisted therapy. Based on the known ef- fects of MDMA, as well as individual reports, this exploratory pilot study in 12 subjects will focus on enhancing functional skills and quality of life in autistic adults with social anxiety.
“We’re looking for something to facilitate positive, ongoing change,” Principal Investigator Charles Grob, M.D., told the Los Angeles Daily News on August 2. “You can’t take an autistic person and make them un-autistic, but you can treat the overwhelming social anxiety.” This study is being conducted in affiliation with the Los Angeles Biomedical Research Institute.
Goals for the 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.
LSD-Assisted Therapy for Anxiety
LSD Annual Report Submitted to FDA
Study completed Location: Solothurn, Switzerland
Principal Investigator: Peter Gasser, M.D.
This study is complete and has been fully funded
On May 16, 2014, the annual report for LSD-assisted psychotherapy for anxiety associated with advanced-stage illness was submitted to the U.S. Food and Drug Administration. The required report provides an overview of the clinical and study methodology issues related to our Swiss LSD-assisted psychotherapy research from February 2013 through February 2014. Our completed study of LSD-assisted psychotherapy was published in the Journal of Nervous and Mental Disease on March 4, 2014. That same day, the The New York Times reported on our study and explained how results like these are helping bring psychedelic research “back into the fold of mainstream psychiatry.”
This is the first study of the therapeutic use of LSD in humans in over 40 years. The first subject was enrolled on April 23, 2008, and the last long-term follow-up interview was conducted on August 8, 2012. The double-blind, placebo-controlled pilot study in 12 subjects found statistically significant reductions in trait anxiety following two LSD-assisted psychotherapy sessions. The results also indicate that LSD-assisted psychotherapy can be safely administered in these subjects, and justify further research. Eleven of the 12 subjects had never used LSD previously. “The study was a success in the sense that we did not have any noteworthy adverse effects,” reports Principal Investigator Peter Gasser, M.D. “All participants reported a personal benefit from the treatment, and the effects were stable over time.”
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
14th and 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
On April 27, 2014, the 14th and final subject was enrolled in our ongoing observational study of ibogaine-assisted treatment for opioid dependence in New Zealand. Since July 2012, Principal Investigator Geoff Noller, Ph.D., has been collecting follow-up data from subjects undergoing treatment at an independent ibogaine center in New Zealand. Eight participants have finished their long-term follow-up and the study is likely to be completed in Spring 2015. 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
Principal Investigator: Thomas Brown, Ph.D.
This study is complete and has been fully funded.
On April 11, 2014, data entry was completed for our observational study of ibogaine-assisted therapy for opioid dependence in Mexico. Data cleanup will begin soon in preparation for submitting the results 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.
Petition Receives 100,000 Signatures (and Counting) for Medical Marijuana Research in Arizona
Clinical Investigator: Sue Sisley, M.D.
Estimated study budget: $876,000
Already raised: $11,000
Needed to complete this study: $865,000
A petition launched on Change.org by Arizona veteran Ricardo Pereyda has gathered over 105,000 signatures in support of MAPS and Dr. Sue Sisley’s eforts to initiate medical marijuana research in Arizona. Launched on July 10, the petition reached 100,000 signatures in just 21 days.
The public outcry against Dr. Sisley’s dismissal from the University of Arizona has reached a national audience. On June 27, the University of Arizona notifed Dr. Sisley that her university appointments would be terminated as of September 26. On July 28, the University of Arizona expectedly denied Dr. Sisley’s appeal for reinstatement, forcing Dr. Sisley to seek a new location for the study. On July 30, the University of Arizona proposed a replacement investigator, ignoring MAPS’ repeated public statements that we will stand behind Dr. Sisley wherever the study is ultimately conducted.
MAPS and Dr. Sisley are seeking a new location for the study within Arizona with reinstatement at the University of Arizona no longer a possibility. Multiple universities outside Arizona have already ofered to host the study.
On July 22, Dr. Andrew Weil, founder of the Arizona Center for Integrative Medicine at the University of Arizona, wrote a letter to University of Arizona President Dr. Ann Weaver Hart expressing his support for Dr. Sisley’s work. “Dr. Sisley has passionately chosen her professional obligation to patients over political pressure; she has chosen science over dogma; and has chosen integrity over censorship. This is the type of individual any University should want on their faculty.”
Dr. Sisley has been working with MAPS since 2010 to initiate a study of the safety and efectiveness of whole plant marijuana, smoked or vaporized, in 70 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD).