More Patients Could Have Access to MDMA Therapy—Before the FDA Approves It

MDMA-assisted therapy trials for PTSD may still be underway, but we’re already seeing efforts to expand access outside a research setting for those who are seeking treatment. In the next calendar year, Somatic Center Portland in Oregon plans to open the doors of a brand new MDMA-Assisted Therapy Center—slated to be the first ever of its kind. Six therapists (including licensed professional counselors, a psychologist, a marriage and family therapist, and a licensed clinical social worker) are on deck to treat folks suffering from PTSD throughout the duration of an unprecedented program sponsored by the for-profit wing of the psychedelic research conglomerate, MAPS (Multidisciplinary Association for Psychedelic Studies). MAPS is comprised of both a nonprofit entity, which conducts research, as well as a Public-Benefit Corp (PBC), which trains therapists, sponsors research sites, and submitted the protocol to the FDA for expanded access to MDMA.

This new center would be the first time, since MDMA became a Schedule I drug in 1985, that patients would be able to receive legal MDMA-assisted therapy outside of a research environment. “We want to get this treatment to as many people as quickly as possible,” says Brad Burge, director of strategic communications at MAPS. “And expanded access is a way to do that.”

This new center would be the first time, since MDMA became a Schedule I drug in 1985, that patients would be able to receive legal MDMA-assisted therapy outside of a clinical environment.

Expanded access, also known as “compassionate use,” is a term defined by the FDA as a “pathway” for patients with serious or life-threatening conditions to gain access to investigational drugs outside of clinical trials, when no other treatment options are available or have worked. In the case of MDMA, MAPS requested that the FDA approve expanded access to treat PTSD, for which there is no reliably effective treatment option. The FDA established expanded access in 1978, after community college instructor Robert C. Randall sued the US government over the right to treat his aggressive and worsening glaucoma with marijuana. (As Psymposia reports, the FDA later clarified in 1987 that expanded access could pertain to otherwise unapproved drugs.) This would be a regulatory first for psychedelic medicines (apart from cannabis, arguably), to be sure; but it would also be the first time for any drug-assisted therapy to achieve expanded access, at all.

As such, this approval would come at the end of a monthslong back-and-forth process between MAPS PBC and the FDA. It also follows nearly three decades of negotiations over each step of the MDMA research process. Those efforts landed a major win back in 2017 when the FDA labeled MDMA-assisted psychotherapy for PTSD a “Breakthrough Therapy,” which is meant to expedite drug development for potentially life threatening conditions (that includes the threat of suicide, in the case of PTSD). If expanded access is secured, MAPS would sponsor approximately nine more expanded access sites to follow Somatic Center Portland’s lead. Each of the ten sites would be independently funded (“sponsorship” in this case means that the FDA approval MAPS’ will have secured would extend to the sites that the organization handpicks for the program).

The demand is strong. More than 50,000 people have subscribed to MAPS for updates on clinical trials and expanded access, says Burge. At Somatic Center Portland, as well as the nine other treatment centers that MAPS would “sponsor,” patients must first fit the criteria for PTSD based on CAPS—the Clinician Administered PTSD Scale—which is a structured diagnostic interview that’s become the “gold standard” in analyzing PTSD. Once they’re screened and evaluated, says Somatic Center Portland’s founder Timothy Crespi, patients would then participate in several preparation sessions ahead of their MDMA-assisted psychotherapy sessions (each, six to eight hours long). After each MDMA-facilitated session, patients would process their experience during an integration session, where there would be no MDMA administered. Finally, Crespi plans for the program to include several more integration sessions on the backend after the active MDMA-facilitated sessions are complete.

The demand is strong. More than 50,000 people have subscribed to MAPS for updates on clinical trials and expanded access.

Therapists must complete MAPS’s MDMA Therapy Training Program, and facilities must adhere to MAPS PBC’s (and the FDA’s) site specifications. For instance, participating treatment centers must maintain a secure drug storage room, have an overnight plan for patients who might need to stay after hours, and obtain a DEA Schedule I license (which requires that the site have a DEA Schedule I license holder, who’s often an MD). 

It won’t be cheap. Insurance doesn’t cover MDMA-assisted therapy (not yet anyway, notes Burge, although MAPS plans to work with health insurance companies on coverage after their current PTSD study finishes the third and final phase of clinical research). The treatment, for now, would be entirely out-of-pocket. Crespi, a licensed counselor specializing in PTSD, estimates that the protocol would cost patients around $15,000. Crespi acknowledges that this therapy would require a huge lump sum upfront, which is why Somatic Center hosted a fundraiser in November to offset costs for those who can’t afford it. The event raised $55,000 for the program in a single night, a to-be-determined portion of which will be allocated to scholarships.

In the context of an entire lifespan, during which someone might grapple with such a debilitating condition, Crespi says he feels that the high price tag isn’t quite so high, after all. “When you compare that [$15,000] to what it costs the average person with severe PTSD over many years of treatment, it’s a drop in the bucket,” he says. “We’re offering a potential cure for PTSD, so it’s worthy of going forward, by far.”