Science & Health
Results On MDMA Therapy For PTSD Are ‘Encouraging,’ But It’s Not Yet Ready For Widespread Adoption, Study Says
A new scientific review finds that five out of six studies into MDMA for post-traumatic stress disorder (PTSD) “provide evidence for the apparent safety and efficacy” of the therapy. But while authors called the results “encouraging,” they say more robust research is needed before MDMA-assisted therapy (MDMA-AT) sees widespread adoption over currently available forms of treatment.
“Though important caveats should be noted, randomized clinical trials of MDMA-AT for PTSD to date broadly demonstrate the apparent efficacy and safety of the approach,” according to new review, which was published in the Journal of Psychedelic Studies. “Participants in full-dose MDMA treatment arms have shown statistically greater improvements on the primary outcome measure (CAPS) in 5/6 studies (83.3%).”
What’s more, the report notes, Phase III trials have shown that effects are significant and long-lasting—”durable to a year post-intervention”—and that risks are relatively minor.
“MDMA administration has been associated with few serious adverse events across all studies,” it adds. “It appears well-tolerated among healthy, young to middle-aged volunteers without medical comorbidities, though potentially risky among those with a prior history of poor cardiovascular health.”
The team of four researchers at Baylor University looked at six randomized controlled trials of MDMA-assisted therapy, of which four were Phase II trials and two were Phase III trials. Results were promising, the authors found, but stemmed from trials they said weren’t sufficient to demonstrate MDMA therapy’s superiority to existing treatments.
“Though research to date is encouraging, there is not yet sufficient evidence to suggest that MDMA-AT should…see widespread adoption over current, validated forms of treatment,” they wrote. “Though many trials demonstrate promising efficacy and safety results for MDMA-AT for PTSD, the literature to date is dominated by poorly blinded, circularly designed studies orchestrated by a single organization with apparent conflicting interests.”
That “single organization” is a reference to the Multidisciplinary Association for Psychedelic Studies (MAPS), which the new report says was “chiefly responsible for the funding, study design, treatment manual, and participant recruitment for every [randomized clinical trial] of MDMA-AT to date.”
“Per the MAPS website, the organization seeks both to conduct research trials to test the efficacy of psychedelic therapies, and to promote policy initiatives for the legalization and wider availability of psychedelic compounds,” the study says. The organization’s “commitment to advocacy has caused some reviewers to question if a priori assumptions have underpinned presuppositions about treatment efficacy and fueled policy proposals before a full investigation of MDMA-AT has occurred,” it adds.
Funding and participant recruitment by MAPS have also drawn criticism, authors continued, pointing to reports that participants “later admitted to withholding negative effects and overreporting positive changes under a self-imposed obligation to help MDMA be approved by FDA.”
“Though perhaps not true to all participants’ experiences,” they wrote, “this vividly illustrates how potential selection bias, demand characteristics, response desirability effects, and commitment to the policy aims of MAPS among research subjects may skew results of RCTs of MDMA-AT.”
The clinical implications of the current state of scientific literature on MDMA-assisted therapy for PTSD are “unclear,” the new study concludes, “given the many unanswered questions pertaining to MDMA-AT’s mechanisms of action, the diversity of training competencies that are relevant to deliver the non-directive therapy, and the absence of any studies that directly compare MDMA-AT to current therapies.”
To improve the robustness of available evidence, it recommends future studies “be undertaken by independent researchers to lessen the influence of allegiance bias and expectancy effects” and that research also include head-to-head trials against existing therapies.
“Given the high costs of MDMA-AT, the simplification and streamlining of the treatment may promote greater treatment accessibility and enhance the feasibility of its widespread adoption,” it says.
The review comes shortly after a U.S. Food and Drug Administration (FDA) advisory panel rejected an application to authorize MDMA-assisted therapy. A group of bipartisan lawmakers and veterans advocates, however, this month asked that officials rethink that guidance.
“What we’re asking for the FDA to recognize is the science,” said Rep. Morgan Luttrell (R-TX), who last month criticized the FDA Psychopharmacologic Drugs Advisory Committee for recommending against against MDMA-assisted therapy in an op-ed for Marijuana Moment.
FDA is expected to make a decision on approving the MDMA application sometime this month.
Ahead of the decision, Lykos Therapeutics, which was founded by MAPS and formerly known as MAPS Public Benefit Corporation, recently announced “new initiatives and measures of additional oversight” around MDMA-assisted therapy if it’s approved by FDA. Among the additions are the establishment of an independent advisory board and collaboration with other health facilities.
“Given the novelty of this approach, we are taking steps to help ensure additional oversight for this drug plus therapy modality, if FDA approved, and to help integrate into the real-world healthcare setting,” Amy Emerson, CEO of Lykos Therapeutics, said in a statement. “It is critical for the millions of people suffering with PTSD, including veterans and survivors of physical and sexual assault, to have access to a potential new treatment option. To this end, we will work with external experts on an independent advisory board, focus our initial commercial rollout on centers of care where there are multiple layers of oversight and collaborate with others around therapy training. This process will establish a strong foundation to ultimately reach more patients in need of access to new treatment options.”
Earlier this week, meanwhile, a bipartisan and bicameral coalition of congressional lawmakers expressed urgency to the federal government as it looks into the possibility of authorizing MDMA-assisted therapy, particularly as it concerns veterans with severe mental health conditions.
A total of 80 members of Congress—including 19 senators and 61 representatives from the House—sent separate letters to the Biden administration and the head of FDA, urging serious consideration of approving the psychedelic as a treatment option PTSD.
MDMA is “one of the most promising and available options to provide reprieve for veterans’ endless PTSD cycle,” the Senate letter says, noting that FDA has already designated it as a breakthrough therapy.
Amid growing calls by veterans advocacy groups and lawmakers, especially Republicans, to speed research and access to psychedelic-assisted therapy, House lawmakers also recently approved amendments to a large-scale spending bill that would authorize U.S. Department of Veterans Affairs (VA) doctors to issue medical marijuana recommendations to military veterans and support psychedelics research and access.
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