Unfortunately, whether this trial will be actually be conducted out depends on whether enough money can be raised.
The US Food and Drug Administration classifies MDMA—the primary active chemical in ecstasy and molly—as a Schedule 1 drug. From the perspective of the US government, MDMA (used recreationally as a party drug because it gives users a sense of euphoria) falls under the same umbrella as heroin, and is considered to have no currently accepted medical use and a high potential for abuse. Regulatory authorities in the UK and EU have classified MDMA similarly.
These classifications have made it really difficult for scientists to study MDMA, even after they get approval from these regulatory bodies.
For example: In August, the US non-profit group the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that they had finally gotten approval from the FDA to two conduct a phase III clinical trials—the last ones needed before the treatment can go to market—examining whether it was possible to treat post-traumatic stress disorder (PTSD) with a combination of MDMA and psychotherapy. Not only that, but the FDA has designated MDMA as a potential breakthrough therapy, meaning that if these trials are successful, the regulatory group would try to speed up the approval process to make it available for patients sooner.
Unfortunately, though, whether this trial will be actually be conducted out depends on whether MAPS can raise enough money—because they can’t get any federal funding. The total study will cost about $25 million. So far, they’ve raised about half of these funds. “We’ve received most of our funding from philanthropists in the tech sector, participants of Burning Man, and similarly minded organizations” including a company in California that makes soaps, Merete Christiansen, the executive manager of MAPS told Quartz in an email. MAPS is also trying to work with researchers affiliated with the Department of Veterans Affairs, but no government agency, for-profit pharmaceutical companies, or major foundations can give them any public funding just yet because of the drug’s legal status. So now they’re asking the public and small private foundations for more money.
Despite the need for funding, Rick Doblin, the executive director and founder of MAPS, sees the FDA’s cooperation with this project as a nod of approval regarding MDMA’s potential therapeutic uses. However, regulatory cooperation alone isn’t enough to get studies on illegal drugs off the ground. An Arizona-based study on the therapeutic use of marijuana, also a Schedule 1 drug, for PTSD in veterans may be shut down in part because the research team can’t get support from the federal Department of Veterans Affairs.
At present, it’s difficult to treat PTSD with psychotherapy alone because often the underlying trauma is too difficult for people to relive with a therapist. But previous work suggests that MDMA helps get PTSD patients to a psychological state where they are comfortable working through those memories. In addition, in MAPS-sponsored phase II trial including 107 PTSD patients, three sessions of MDMA and two months of therapy was successful in treating 61% of participants. A follow up conducted a year later showed almost 70% of these patients no longer suffered from symptoms of PTSD.
The proposed phase III clinical trials would compare the effects of three guided MDMA sessions in conjunction with psychotherapy to treat patients with PTSD compared to a control group that receives psychotherapy with a placebo. With adequate funding, these trials could begin as early as next spring and conclude in the next two years. Without it, the group won’t be able to pay for the hours of work required from therapists, data managers, and research site coordinators to conduct the trial.