Setback for MDMA-assisted Psychotherapy Campaign in US

On Tuesday, the Advisory Committee of the US Food and Drug Administration (FDA) met to discuss the application for MDMA to be used as an adjunct to psychotherapy for post-traumatic stress disorder (PTSD). The committee’s recommendation informs the FDA’s final decision, which is expected in August.

Phase 3 trials had shown that “participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms,” according to the committee’s pre-hearing briefing. Yet against all expectations, the committee voted 10 to 1 that MDMA’s risks outweigh its therapeutic benefits.

The decision can only be taken as a blow to therapeutic ambitions for psychedelics more generally. The MDMA-for-PTSD application was brought by Lykos Pharmaceuticals, the corporate spin-off of the high-profile Multidisciplinary Association for Psychedelic Studies (MAPS).

MDMA, or 3,4-methylenedioxymethamphetamine, came to fame through rave culture as the active ingredient in ecstasy pills. The drug sets off a serotonin cascade that produces feelings of love and acceptance in the consumer.

For psychotherapy and especially PTSD, this brings with it an enhancement of “emotional and cognitive processing of trauma,” as Lykos argued. This arguably correlates with indigenous uses of psychedelics in Amazonia.

However, though the therapeutic possibilities of MDMA were hardly doubted, the risks were murkier. The committee’s concerns about adverse cardiac events and liver toxicity were not assuaged. MDMA is correlated with these outcomes in users as part of its history as a party drug.

MDMA-assisted therapy also confirms poorly with the regime of scientific investigation and verification that structures medical regulation. Its effects are so noticeable that placebo controls become meaningless, and neither can therapists treat those under its effects the same as they threat the patients who receive a placebo.

Rick Doblin, founder and president of MAPS.

The concerns were not limited to MDMA itself, however. The applicant, Lykos/MAPS, was described as “a therapy cult” by one psychedelics advocate, Nese Devenot, in her submission to the committee

Devenot noted the comments of MAPS head, Rick Doblin, that his ultimate goal is “spiritualizing humanity”. Doblin has proclaimed MDMA will lead to “net-zero trauma”. “Once it’s a medicine, we’ll move forward with the training of therapists,” Doblin wrote in 2015. “Then we’ll have world peace.”

MAPS is alleged by Devenot to use hypnosis and neuro-linguistic programming (NLP) techniques in its fundraising. “Cult indoctrination is a significant iatrogenic risk for a therapy model that introduces totalizing ideologies into a context of pharmacologically induced and heightened suggestibility,” Devenot argued.

Again, the final decision from the FDA is not due until August. Yet if, as is now anticipated, the application is rejected, it will leave Australia as the only country that legalises MDMA for PTSD.

Thumbnail image courtesy of @kellysikkema via Unsplash.

Sign Up To Our Free Newsletter