Following the lifting of a clinical hold imposed by the US Food and Drug Administration (FDA) that had delayed research for several months, a ground-breaking trial investigating MDMA-assisted treatment in a group setting is ready to begin. The group therapy trials’ objective is to make MDMA-assisted therapy more affordable and readily accessible if it is given the go-ahead for therapeutic use in the upcoming years.
MDMA-assisted psychotherapy for PTSD (post-traumatic stress disorder) is possibly the most clinically advanced application in the rapidly expanding field of psychedelic medicine. The therapy technique, which has been promoted for years by the Multidisciplinary Association of Psychedelic Studies (MAPS), is currently undergoing advanced Phase 3 studies with remarkably promising early findings.
The FDA will likely approve MDMA-assisted therapy for PTSD within the next several years, but issues with equity and accessibility loom over the decision. In addition, the MDMA-assisted therapy regimen calls for many sessions spread out over several months, and this form of private therapy is expensive.
MDMA-assisted therapy is expected to cost anywhere between US$8,000 and $15,000. This includes several pre- and post-MDMA therapy sessions and up to three eight-hour MDMA sessions with two psychotherapists onsite.
MAPS has provided compelling evidence that the upfront cost of a course of MDMA-assisted therapy is far less than the ongoing annual medical costs for treating chronic PTSD. Unfortunately, many people will undoubtedly be unable to access the treatment protocol due to its high price and intensity. Because of this, MAPS is looking into whether MDMA-assisted therapy can be introduced into group therapy sessions to lower the cost of treatment.
MAPS clarified in its study proposal for group therapy MDMA treatments, “The current FDA-guided protocol for individual patient MDMA-assisted therapy for PTSD, which requires numerous two-therapist sessions for each individual patient, may present accessibility challenges for some, particularly individuals from marginalized populations.
A group therapy protocol, in which most of the therapy sessions are conducted in a group setting, would significantly decrease both the time and cost associated with treatment, further supporting accessibility and rapid post-approval dissemination.”
It was first suggested to do a Phase 2, open-label feasibility study last year. The trial, scheduled to take place at the Portland Veterans Affairs (VA) Medical Center in Oregon, was given the go-ahead by the VA Institutional Review Board at the beginning of this year but was unexpectedly stopped by the FDA in February.
The FDA’s main safety issue with the proposed trial was the absence of an overnight stay requirement in a monitored environment for participants following each MDMA session. This protocol was previously required for safety concerns in Phase 2 clinical research on MDMA for PTSD; however, MAPS claims that later Phase 3 trialing has lifted this requirement and deemed it safe for all participants.
After several months of discussions, MAPS has finally declared that the clinical hold on the experiment has been removed and that the FDA has approved the study’s start without needing overnight stays. According to Allison Coker, associate director of regulatory relations at MAPS, the overnight stays in Phase 2 studies were implemented out of an excess of caution, and subsequent Phase 3 trial data has shown they are not required to maintain trial safety.
Coker explained, “Though we had no data to suggest there was a concern about safety overnight, these stays became required from the FDA perspective. In the Phase 3 program, we’re collecting safety data from participants with and without overnight stays to gather evidence as to whether overnight stays are necessary.
From the data we have so far, that doesn’t seem to be the case. Therefore, we are pleased that the safety data in the Phase 3 sub-study without overnight stays could support the FDA in making the data-driven decision to permit no overnight stays in this important group study research.”
Many of the protocols developed by MAPS’ prior MDMA for PTSD trials will still be used in the group therapy experiment that will soon start. However, one of the most noteworthy changes will be substituting group treatment sessions for a handful of pre- and post-MDMA individual therapy sessions.
The protocol calls for two MDMA drug sessions, one of which will continue to be conducted alone with two therapists and the other in a larger group setting. The group MDMA sessions will continue to be primarily solo experiences, with participants being provided with headphones and eye masks to guide the experience inwardly. Each group will include six individuals, and four therapists will oversee the MDMA sessions.
Chris Stauffer, the trial’s chief investigator, said, “There is so much yet to explore regarding the relational potential of MDMA-assisted therapy, and research on group therapy combined with MDMA sessions is a logical next step. What drives this work for me are the unique therapeutic properties of group cohesion that I’ve witnessed in my previous group therapy trials with oxytocin and psilocybin.”
Stauffer added that effectiveness rather than accessibility interests him most about this treatment approach. Based on this type of communal therapeutic activity, he thinks group therapy work could provide innovative and substantial results. Meanwhile, other compounds continue to show promise for PTSD symptoms. A 2026 clinical trial found that a prescription THC medication eliminated trauma-related nightmares in more than a third of patients, offering a targeted option for one of PTSD’s most stubborn symptoms.
