Treating PTSD with MDMA-Assisted Therapy
MDMA capsules from MAPS’ completed Phase 2 trial of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado.
Phase 3 Trials:
Study Initiation Visits for 8 Sites Completed
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.
MAPS-sponsored researchers have completed study initiation visits for FDA-regulated Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at eight United States locations.
MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for PTSD at planned Phase 3 sites across the United States and Canada. A total of 19 participants have completed treatment for this study. The purpose of this study is to provide the final training for our Phase 3 co-therapy teams. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS’ therapy training team.
Seven study sites are now enrolling and seven sites are fully enrolled.The study is expected to be completed in early 2019.
Phase 3 clinical trials starting Fall 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD. Over a 12-week treatment period, participants will be randomized to receive 12 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.
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.
MAPS’ 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
Farmington, CT | research institution
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 | research institution
Montreal, Canada | private practice
Vancouver, Canada | research institution
Israel | research institution
MAPS and MPBC are excited to reach this milestone toward bringing healing to those suffering from PTSD with MDMA assisted psychotherapy.
There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Help us heal trauma: maps.org/donate.
Therapist Training Study Enrolls 67th Participant
Location: Charleston, South Carolina, and Boulder, Colorado
Principal Investigator: Michael Mithoefer, M.D., (Charleston), and Marcela
Ot’alora, M.A., L.P.C. (Boulder)
Sub-Investigator: Annie Mithoefer, B.S.N., (Charleston)
As of October 10, 2018, the 67th participant officially 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. Michael Mithoefer, M.D., is serving as Principal Investigator at the site in Charleston, South Carolina with Sub-Investigator Ann Mithoefer, B.S.N.
Cognitive Behavioral Conjoint Therapy for PTSD: Sixth Dyad Completes Long-Term Follow-Up Interview, Study Close-Out Completed
Location: Charleston, South Carolina
Principal Investigator: Michael Mithoefer, M.D.
Sub-Investigator: Candice Monson, Ph.D.
In May 2018, the sixth dyad completed their long-term follow-up interview in our study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for posttrau- matic stress disorder (PTSD) at our Charleston, South Carolina site led by Principal Investigator, Michael Mithoefer, M.D., and Sub-Investigator, Candice Monson, Ph.D.. The study close-out was conducted in July 2018.This study has enrolled dyads with one participant diagnosed with PTSD and one concerned significant other who does not have PTSD but does experience psychosocial distress. MDMA will be 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: First Participant Receives Experimental Treatment
Location: Emory University in Atlanta,Georgia
Principal Investigator: Barbara Rothbaum, Ph.D.
On August 27, 2018, the eighth participant compl
eted experimental treatment in our ongoing study of the effect 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 hoping to eventually conduct a subsequent study exploring the combination of MDMA with Prolonged Exposure in people with PTSD.
MDMA Therapy Training Program: Expanded Access
Therapy Training Team: Michael Mithoefer, M.D.,
Annie Mithoefer, B.S.N., Marcela Ot’alora G., M.A., L.P.C.
In the fall of 2018, MAPS plans to apply for a special U.S. Food and Drug Administration (FDA) program called Expanded Access (EA), which allows the use of an investigational medical product (one that has not yet been approved by the FDA) outside of a double-blind clinical trial. The program’s purpose is to grant access to potentially beneficial investigational treatments for people facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available.The FDA’s website has more information on its Expanded Access program.
MAPS has already had positive preliminary discussions about Expanded Access with DEA on December 19, 2017, and with FDA on December 20, 2017. If Expanded Access for MDMA-assisted psychotherapy for PTSD is accepted, new sites in the U.S. meeting the requirements may obtain permission and undergo training to administer open-label MDMA-assisted psychotherapy to eligible patients with treatment-resistant PTSD, under a MAPS protocol. Qualified Expanded Access site applicants will have 1) a suitable facility to conduct MDMA- assisted psychotherapy and meet drug storage requirements, 2) qualified therapy team who have completed the MDMA PTSD Therapy Training Program, operated by MAPS Public Benefit Corporation (MPBC), 3) Medical Doctor who can obtain a DEA Schedule I license for MDMA. Sites must also gain DEA approval to manage, store, and administer MDMA, a controlled substance.As MAPS gets closer to application, the requirements will be better understood.
Currently, MPBC is updating its website, including web pages for the MDMA Therapy Training Program (maps.org/training) and an online training application for eligible sites and providers. Completed applications for potential sites to work on a U.S. FDA Expanded Access protocol for MDMA- assisted psychotherapy will be reviewed on an ongoing basis, starting late 2018 and continuing through the duration of the protocol, pending approval. Registration for the first training cohort will take place early 2019; training events will take place starting March 2019, in locations across the U.S.
We encourage each site, in choosing location and therapy teams, to consider diversity, inclusivity, and cultural and racial competence. One of the most robust ways to provide accessible care is to train therapists and practitioners from diverse backgrounds, including people of color and from the LGBTQ+ community. If you are a therapist from a marginalized community, we encourage you to reach out to us at email@example.com.
At this point, the training program is not accepting applications, however you can sign up to receive updates when future training opportunities become available.
Learn more at maps.org/training.
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: Study Closeout Completed in June 2018
Location: Marin, California
Principal Investigator: Phil Wolfson, M.D.
Co-Therpaist: Julane Andries, L.M.F.T.
A close-out visit of MAPS’ Phase 2 clinical trial of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif., took place on June 20-21, 2018. Associate Director of Clinical Operations Rebecca Matthews, Clinical Research Associate Alia Lilienstein, and Clinical Research Associate Joselyn Lindgren of MAPS conducted the visit. Led by Principal Investigator Phil Wolfson, M.D., with Co-Therapist Julane Andries, L.M.F.T., this study gathered preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety associated with a diagnosis of a life-threatening illness. Goals for this study include (1) gathering data on the safety and effectiveness of MDMA-assisted psychotherapy for participants 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.
Medical Marijuana Research
76th and Final Participant Enrolls in Smoked Marijuana Trial for Chronic PTSD in Veterans
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)
As of October 10, 2018, 76 of 76 participants enrolled and received study drug in the first ever clinical trial of smoked marijuana (cannabis) for treatment of symptoms of posttraumatic stress disorder (PTSD) in U.S. veterans, nearly completing enrollment. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial is evaluating the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans.
Data Collection Survey Continues
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 results of the survey are currently being summarized and prepared for publication, at which point the survey will shift its focus to general ayahuasca use for a variety of conditions, including PTSD, depression, and substance abuse/addiction. The data collection is sponsored by MAPS, with Jessica Nielson, Ph.D., as Principal Investigator.
Ayahuasca is a psychoactive brew or tea most commonly derived from Banisteriopsis caapi, a vine containing monoamine oxidase inhibitors (MAOIs), and the leaves of Psychotria viridis or other plant containing N,N-dimethyltryptamine (DMT), and often several other admixture plants. Ayahuasca is legal in many countries in South America.
The revised survey is a shorter and simplified version of the original survey, and we welcome participation from anyone that has tried ayahuasca in any context or setting, including those who took the first version of the survey. To participate in the survey, visit surveymonkey.com/r/AyaPTSD.
Ibogaine-Assisted Therapy for Drug Addiction
Observational Research Published in American Journal of Drug and Alcohol Abuse
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. Sponsored by MAPS in Mexico and New Zealand, both studies show that ibogaine should be further studied as a potential treatment for opioid dependence in rigorously controlled studies.
Ultimately, the authors of the studies conclude that given the potential demonstrated by ibogaine’s substantive treatment effect in opioid detoxification, its novel (though not yet fully understood) pharmacological mechanism of action, and its clinical effect in opioid dependent participants who have not satisfactorily responded to other treatments, ibogaine has promise for future research and development as a novel pharmacotherapy for opioid addiction.
Download both articles for free at maps.org/ibogaine.
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 will open in Fall 2018. Please bookmark our Participate in Research page and check it frequently for updates. maps.org/participate/participate-in-research