MAPS Bulletin Summer 2019: Vol. 29, No. 2 Research Edition
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials of MDMA-Assisted
Psychotherapy for PTSD
Our FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD are taking place at 15 locations across the United States, Canada, and Israel.
The Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting.
The Phase 3 trials will be conducted at the following study sites:
• Los Angeles, CA | private practice
• San Francisco, CA | research institution
• San Francisco, CA | private practice
• Boulder, CO | private practice
• Fort Collins, CO | private practice
• New Orleans, LA | private practice
• New York, NY | research institution
• New York, NY | private practice
• Charleston, SC | private practice
• Madison, WI | research institution
• Boston, MA |private practice
• Montreal, Canada | private practice
• Vancouver, Canada | research institution
• Be’er Ya’akov, Israel | research institution
• Tel HaShomer, Israel | research institution
In MAPS’ completed Phase 2 trials with 107 participants, 56% no longer qualified for PTSD after treatment with MDMA-assisted psychotherapy, measured two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. Most subjects received just 2–3 sessions of MDMA-assisted psychotherapy. All participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.
On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies.
There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Help heal trauma: maps.org/donate.
Israel Approves Compassionate Use
of MDMA-Assisted Therapy for PTSD
On February 3, 2019, the Israeli Ministry of Health announced the approval of compassionate use for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), which will allow 50 patients to receive the therapy within a treatment protocol. Patients with PTSD will be eligible to receive treatment at four sites throughout Israel, including Rambam Medical Center in Haifa and psychiatric hospitals in Be’er Yaakov, Lev Hasharon, and Be’er Sheva.
Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD: All Sites Fully Enrolled
As of April 3, 2019, all sites are officially fully enrolled in our Phase 2 open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. The purpose of this study is to provide the final training and supervision for our co-therapy teams as they work with one study participant with PTSD. The same treatment approach will be used in Phase 3. We are currently developing long-term follow-up protocol for this multi-site open-label Phase 2 study, which will assess symptoms of PTSD in participants 12 months after completing treatment.
Therapist Training Study Enrolls 79th Participant
Ongoing study
Location: Charleston, South Carolina, and Boulder, Colorado
Principal Investigator: Zhenya Gelfand, M.D., (Charleston);
Marcela Ot’alora, M.A., L.P.C. and Waul Garas, M.D. (Boulder)
Sub-Investigator: Annie Mithoefer, B.S.N., (Charleston)
On June 5, 2019, the 79th participant enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. Enrollment in this multi-site study is limited by invitation only to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD. The Boulder, Colorado, study site is led by Principal Investigator Marcela Ot’alora, M.A., L.P.C. Zhenya Gelfand, M.D., is serving as Principal Investigator at the site in Charleston, South Carolina.
Cognitive Behavioral Conjoint Therapy for PTSD: Study Close-Out Completed
Completed Study
Location: Charleston, South Carolina
Principal Investigator: Michael Mithoefer, M.D.
Sub-Investigator: Candice Monson, Ph.D.
In July 2018, the study close-out was completed for our study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for posttraumatic stress disorder (PTSD at our Charleston, South Carolina site led by Principal Investigator, Michael Mithoefer, M.D., and Sub-Investigator, Candice Monson, Ph.D. This study enrolled six dyads with one participant diagnosed with PTSD and one concerned significant other who does not have PTSD but does experience psychosocial distress. MDMA was administered to both participants to help facilitate communication and connection between participants and therapists. The primary goal of this study is to develop a combined method of MDMA with CBCT for PTSD. This is the first MAPS-sponsored MDMA study conducted with VA-affiliated researchers and the first to employ measures developed for the DSM-5. There are several important reasons to include significant others in PTSD treatment, in addition to the data supporting the efficacy of CBCT for PTSD.
Startle Testing with MDMA: 17th Participant Receives Experimental Treatment
Ongoing study
Location: Emory University in Atlanta, Georgia
Principal Investigator: Barbara Rothbaum, Ph.D.
On July 15, 2019, the 17th participant completed experimental treatment in our ongoing study of the effects of MDMA on startle testing in healthy volunteers. Led by Principal Investigator Barbara Rothbaum, Ph.D., this study is conducted at Emory University in Atlanta, Georgia. This research group is planning to conduct a subsequent study exploring the combination of MDMA with Prolonged Exposure in people with PTSD.
MDMA Therapy Training Program Update
Training Program
Therapy Training Team: Michael Mithoefer, M.D.,
Annie Mithoefer, B.S.N., Marcela Ot’alora G., M.A., L.P.C.
In January 2019, MAPS Public Benefit Corpo
ration (MAPS PBC) submitted an MDMA-assisted psychotherapy for PTSD protocol to the U.S. Food and Drug Administration (FDA) as part of an application to participate in the FDA Expanded Access (EA) program. We’ve received and responded to several rounds of comments from the FDA regarding our protocol submission for Expanded Access (EA), and we will hear from the FDA soon. The Expanded Access program’s purpose is to grant access to potentially beneficial investigational treatments for individuals or populations facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. If approved, MAPS PBC would likely start with a limited number of qualified sites to provide MDMA-assisted psychotherapy for participants with treatment-resistant PTSD under a MAPS PBC protocol.
Sites in the U.S. and U.S. territories interested in being considered to participate in an MDMA/PTSD protocol may now apply with MAPS PBC to assess eligibility and obtain the prerequisite training to administer MDMA-assisted psychotherapy. The basic requirements of a qualified site are (1) a treatment facility conducive to MDMA-assisted psychotherapy; (2) a therapy team qualified and able to complete the MDMA Therapy Training Program; and (3) a prescribing physician who can obtain a DEA Schedule I license for MDMA.
Site and practitioner application procedures are posted on the MAPS PBC website (mapspublicbenefit.com). Each site must submit one site questionnaire. Only applicants affiliated with a qualifying site can be considered for training at this time. MAPS PBC will review applications on an ongoing basis, as they are received.
The MDMA Therapy Training Program has launched a series of trainings to prepare therapy providers to become eligible to work on an MDMA-assisted psychotherapy for PTSD protocol.
On May 4–11, 2019, 53 practitioners gathered in Colorado to receive training from Marcela Ot’alora M.A., L.P.C., and Bruce Poulter, R.N., on MDMA-assisted psychotherapy for PTSD in a six-and-a-half-day training retreat.
From June 23–29, 2019, Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., led a six-and-a-half-day training retreat in Northern California focused on MDMA-assisted psychotherapy for PTSD. This retreat was organized by the CIIS’ Center for Psychedelic Therapies and Research (CPTR) with support from the MDMA Therapy Training Program. More than 90 practitioners travelled from across the U.S. and internationally to receive training.
The MDMA Therapy Training for Communities of Color took place August 10–17, 2019, in Louisville, Kentucky, led by Marcela Ot’alora M.A., L.P.C., and Monnica Williams, Ph.D., A.B.P.P., with support from additional trainers. The one-and-a half-day Psychedelic Medicine and Cultural Trauma Community Workshop took place August 10–11 and was open to the public. (See sidebar, page 5.) Scholarships and tiered tuition rates, for both therapy providers and affiliated community organizers who work with communities of color, were available for this event through generous funding from the Open Society Foundation (OSF), Libra Foundation, RiverStyx Foundation, Psychedelic Science Funders Collaborative (PSFC), and Dr. Bronner’s.
Annie Mithoefer and Michael Mithoefer will be leading the final training retreat for 2019 on October 1–8 in Asheville, North Carolina.
Sign up for the Training Program Newsletter to receive updates on upcoming trainings: mapspublicbenefit.com.
Medical Marijuana Research
76th and Final Participant Completes Treatment
Ongoing study
Location: Phoenix, Ariz.
Coordinating Principal Investigator:
Marcel Bonn-Miller, Ph.D. (University of Pennsylvania)
Co-Investigator/Site Principal Investigator:
Sue Sisley, M.D. (private practice) and
Co-Investigator: Paula Riggs, M.D. (University of Colorado)
On February 8, 2019, MAPS-sponsored researchers officially completed the first-ever clinical trial of smoked marijuana (cannabis) as a treatment for PTSD symptoms, with all 76 veterans enrolled and treated. The data from the study are now being analyzed and prepared for publication later this year in a peer-reviewed biomedical journal.
Disclaimer: This study was supported by funding from the Colorado Department of Public Health and Environment (CDPHE). The content and opinions are those of the grantee/authors and do not represent the official views of CDPHE.
Ayahuasca Research
Data Collection Survey Continues
Ongoing study
Principal Investigator: Jessica Nielson, Ph.D.
We are currently collecting responses for the revised version of our anonymous questionnaire about the potential risks and benefits associated with using ayahuasca in treatment for PTSD. The data collection is sponsored by MAPS, with Jessica Nielson, Ph.D., as Principal Investigator. We welcome participation from anyone that has tried ayahuasca in any context or setting, including those who took the first version of the survey. Participate in the survey at surveymonkey.com/r/AyaPTSD.
Ibogaine-Assisted Therapy for Drug Addiction
Observational Research Published in American
Journal of Drug and Alcohol Abuse
Study completed
Locations: Mexico and New Zealand
Principal Investigators: Thomas Kingsley Brown, Ph.D.
(Mexico), and Geoff Noller, Ph.D. (New Zealand)
On May 25 and April 12, 2017, the promising results of MAPS-sponsored observational studies of treating opioid dependence with ibogaine-assisted therapy were published in the peer-reviewed American Journal of Drug and Alcohol Abuse. Download both articles for free at maps.org/ibogaine.
Psychedelic Medicine and Cultural Trauma Community Workshop & MDMA Therapy Training for Communities of Color
The Psychedelic Medicine and Cultural Trauma Community Workshop and the MDMA Therapy Training for Communities of Color events took place in Louisville, Kentucky on August 10–17, 2019. The community leaders, organizers, advocates, therapists, and healers who came together at these two powerful events truly embody the resilient strength and celebration inherent in a gathering around growth, healing, and psychedelic medicine. Inspiring workshop presentations explored community, culture, oppression, racism, traditional healing practices, ritual, earth-based wisdom, harm reduction, integration, policy, education, psychedelic medicines, clinical research, trauma therapy, intergenerational trauma, music, spirituality, and body wisdom.
Fifty-six trainees learned about the therapeutic approach of MDMA-assisted psychotherapy. Of 56 trainees, 51 were clinicians and researchers of color from across the US. Trainees brought wisdom and experience to conversations about delivering culturally-informed care. The week’s themes included cultivating the power of community, slowing to the pace of trust and relationship-building, and being involved in local collaborations and initiatives to deliver care and trainings with integrity. Belinda Eriacho, MPH, offered a presentation on the history of traditional use of plant medicines in Native populations, including the use of sassafras, which is a precursor to MDMA. This event also inspired and motivated a number of organizational insights and learnings about working cross-culturally and at the cutting edge.
Many people contributed to these event
s in a number of different ways. Presenters during the two events included: Sara Reed, MS, MFT, Camille Barton, Ismail Lourido Ali, JD, Monnica Williams, PhD, ABPP, Belinda Eriacho, MPH, Carl Hart, PhD, Marcela Ot’alora, LPC, Mellody Hayes, MD, Kwasi Adusei, DNP, PMHNP-BC, Jamilah R. George, MDiv, Joe Tafur, MD, Terence Ching, MS, Marca Cassity, LMFT, Rick Doblin, PhD, Shannon Carlin, MA, AMFT, Angella Okawa, MA, LMFT. Additional support and strength was provided by MAPS and MAPS PBC staff including Angelica Garcia, Natalie Ginsberg, Ritika Aggarwal, Sarah Scheld, as well as MAPS PBC Advisory Council Members Angella Okawa, Camille Barton, Jae Sevelius, Marca Cassity, and Sara Reed. In addition, a number of community leaders rose up and demonstrated their care, insights, and leadership throughout the events.
We are excited to work toward making this training and treatment modality more applicable and accessible. Thank you to all who supported these events. Toward collective liberation!
Participate in Research
MAPS sponsors clinical trials around the world that require human participants. Our studies have strict enrollment criteria based on the goal of the study and the condition the study is investigating. Phase 3 trial participant enrollment is open at multiple sites. Please bookmark our Participate in Research page and check it frequently for updates.
maps.org/participate/participate-in-research
Psychedelic Medicine and Cultural Trauma Community Workshop & MDMA Therapy Training for Communities of Color
The Psychedelic Medicine and Cultural Trauma Community Workshop and the MDMA Therapy Training for Communities of Color events took place in Louisville, Kentucky on August 10–17, 2019. The community leaders, organizers, advocates, therapists, and healers who came together at these two powerful events truly embody the resilient strength and celebration inherent in a gathering around growth, healing, and psychedelic medicine. Inspiring workshop presentations explored community, culture, oppression, racism, traditional healing practices, ritual, earth-based wisdom, harm reduction, integration, policy, education, psychedelic medicines, clinical research, trauma therapy, intergenerational trauma, music, spirituality, and body wisdom. Fifty-six trainees learned about the therapeutic approach of MDMA-assisted psychotherapy. Of 56 trainees, 51 were clinicians and researchers of color from across the US. Trainees brought wisdom and experience to conversations about delivering culturally-informed care. The week’s themes included cultivating the power of community, slowing to the pace of trust and relationship-building, and being involved in local collaborations and initiatives to deliver care and trainings with integrity. Belinda Eriacho, MPH, offered a presentation on the history of traditional use of plant medicines in Native populations, including the use of sassafras, which is a precursor to MDMA. This event also inspired and motivated a number of organizational insights and learnings about working cross-culturally and at the cutting edge. Many people contributed to these events in a number of different ways. Presenters during the two events included: Sara Reed, MS, MFT, Camille Barton, Ismail Lourido Ali, JD, Monnica Williams, PhD, ABPP, Belinda Eriacho, MPH, Carl Hart, PhD, Marcela Ot’alora, LPC, Mellody Hayes, MD, Kwasi Adusei, DNP, PMHNP-BC, Jamilah R. George, MDiv, Joe Tafur, MD, Terence Ching, MS, Marca Cassity, LMFT, Rick Doblin, PhD, Shannon Carlin, MA, AMFT, Angella Okawa, MA, LMFT. Additional support and strength was provided by MAPS and MAPS PBC staff including Angelica Garcia, Natalie Ginsberg, Ritika Aggarwal, Sarah Scheld, as well as MAPS PBC Advisory Council Members Angella Okawa, Camille Barton, Jae Sevelius, Marca Cassity, and Sara Reed. In addition, a number of community leaders rose up and demonstrated their care, insights, and leadership throughout the events. We are excited to work toward making this training and treatment modality more applicable and accessible. Thank you to all who supported these events. Toward collective liberation!
