Research News: Winter 2018

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

Ongoing study
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

Completed Study
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

Ongoing study
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

Training Program
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 training@mapsbcorp.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.