Psychedelic Science

MDMA-Assisted Psychotherapy for PTSD

Posttraumatic stress disorder (PTSD) is a disorder that describes the issues faced by many people after they experience or witness a traumatic event. Anyone who has been exposed to traumatic events that causes a serious fear for their life or the lives of others is at risk to develop PTSD. People typically affected include: survivors of violent acts and disasters, emergency responders to traumatic events, people who experience the sudden death of a loved one, anyone who has been abused, neglected children, and combat veterans. However, many other events can be traumatic as well, particularly to people of color, including police harassment, distressing childbirth experiences, and incarceration.

Research team

The UConn therapist team for MDMA-assisted psychotherapy for PTSD/race-based trauma (from left): Sara J. Reed, M.S., MFT Associate (study coordinator/therapist); Michael D. Kisicki, M.D. (co-investigator; therapist); Monnica Williams, Ph.D. (lead investigator; therapist); Terence H. W. Ching, M.S. (therapist); Jamilah R. George, M.Div. (therapist).

The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit research and educational organization that is currently sponsoring Phase 3 clinical trials of 3,4-methylenedioxymethamphetamine (MDMA) as a tool to assist psychotherapy for severe PTSD. Importantly, MDMA used in these trials is not the same as the street substances known as "ecstasy" or "molly," since these drugs frequently also contain unknown and/or dangerous adulterants. In MDMA-assisted psychotherapy, MDMA is only administered a few times, unlike most medications for mental illnesses which are often taken daily for several years. More information on MDMA can be found in the MAPS Investigator Brochure, which is available online here.

Preliminary studies suggest that MDMA can catalyze powerful psychotherapeutic work in helping people overcome PTSD by reducing fear of traumatic memories and increasing feelings of trust and compassion towards others without causing sensory distortions or inhibiting access to difficult emotions. As such, MDMA could increase the effectiveness of psychotherapy by strengthening the alliance between therapist and patient.

At the University of Connecticut, we participated in a MAPS-sponsored, FDA reviewed Phase 2 open-label study in preparation for a Phase 3 randomized clinical trials. Our focus has been on the recruitment of ethnoracial minority participants who meet criteria for PTSD. Our team's work is dedicated to culturally-sensitive and respectful treatment approaches for people of diverse backgrounds.

We recognize that doing things the way they have always been done will not be sufficient to open the doors of these therapies to people of color. A culturally-informed approach must be used. Here are some of the efforts that have been made to date to ensure the ongoing MDMA research is culturally inclusive:

  • Addition of a study site focused on the ethnic minority trauma experience
  • Revision of informed consent documents for all sites to improve understanding and acceptability to people of color
  • Diversification of the UConn treatment team at every level
  • Ongoing cultural training for all UConn team members, with an emphasis on cultural humility
  • Re-examination and revision of the setting and music used during MDMA sessions for cultural congruence
  • Recognition and validation of experiences of racial oppression at a cultural and individual level
  • Integration and specialized training for independent rater pool, with ongoing supervision for cultural differences

Read more about this study in the Journal of Psychedelic Studies.

Expanded Access

The next phase of this work is the Expanded Access program, which will be starting in early 2021 in the US. Expanded Access, also called Compassionate Use, allows patients to have use of an investigational medical product (one that has not yet been approved by the FDA) outside of a randomized 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. This program will allow MDMA-assisted psychotherapy to be available for people who have not responded to traditional therapies for PTSD, and it will also provide additional data on drug safety and how various subpopulations may respond to the treatment. Our work will be focused on people of color with PTSD.

More about the MDMA-PTSD Expanded Access Program at MAPS: Protocol and Timeline

More about the MAPS Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD (EAMP1) at ClinicalTrials.gov