05/19/2026
thank you Dr. Gold! For the full article go to PSYCHOLOGY TODAY
What’s Up with Molly (M**A) After the Executive Order? Some likely scenarios in FDA approval process for the empathogen M**A in PTSD.
KEY POINTS:
The recent presidential Executive Order on psychedelic therapies has intensified the debate on M**A.
M**A is the primary example of an empathogen—inducing empathy, openness, and interpersonal connection.
M**A is a drug of abuse and both promising and challenging medication for treating severe PTSD.
The Executive Order may reposition the VA/DoD as major research infrastructure for M**A studies.
Few compounds better illustrate the tension between therapeutic promise, regulatory skepticism, abuse liability, and political momentum surrounding post-traumatic stress disorder (PTSD) than the drug M**A, a drug that acts as both a stimulant and a hallucinogen (empathogen and an entactogen) known by the street names Ecstasy and Molly. At one time primarily associated with rave culture, it is used to change energy, mood, empathy, distort time perception, and enhance the enjoyment of tactile experiences and pleasure. M**A continues to be studied as a potentially transformative psychiatric intervention for PTSD.
The recent presidential Executive Order on psychedelic therapies did not legalize M**A, nor did it bypass FDA authority. Instead, it may have shifted where the future of psychedelic psychiatry will ultimately be decided. The Executive Order apparently repositions the Department of Veterans Affairs (VA) and the Department of Defense (DoD) as major research infrastructures for psychedelic medicine.
This means that the future of M**A-assisted therapy may depend less on advocacy groups and much more on whether federally supervised studies on veterans and active-duty military personnel demonstrate durable, standardized, and clinically meaningful outcomes.
From “Molly” to Medicine
Historically, M**A referred to pressed tablets sold in dance clubs, while “Molly” became shorthand for supposedly pure crystalline M**A. In reality, however, forensic analyses have repeatedly shown that illicit products sold as M**A are often adulterated with methamphetamine, synthetic cathinones, ketamine analogs, caffeine, co***ne, or fentanyl.
M**A became widely known as the “love drug” because of its empathogenic effects. Users frequently reported increased emotional openness, heightened interpersonal trust, reduced defensiveness, and stronger feelings of emotional connection. These same effects also raised concerns regarding emotional suggestibility, compromised judgment, and vulnerability to exploitation.
This double identity—as a possible therapeutic agent and a recreational drug of abuse—continues shaping M**A’s regulatory history.
As a recent editorial in the journal Lancet (2026) observed, the principal challenge facing psychedelic psychiatry is to “separate hope firmly from hype.” The editorial noted that psychedelic-assisted therapy trials remain difficult to blind effectively (or to hide what they are, so subjects can’t tell whether they took the study drug or the placebo). Importantly, however, the editorial characterized many FDA concerns regarding M**A-assisted psychotherapy as “remediable issues".
Why the FDA Rejected M**A in 2024
Early randomized trials demonstrated unusually large effect sizes in patients with severe and treatment-resistant PTSD, including veterans, first responders, and survivors of chronic trauma. Phase-2 and Phase-3 studies showed substantial reductions in Clinician-Administered PTSD Scale (CAPS) scores, and the pivotal MAPP1 trial published in Nature Medicine in 2021 became a landmark for psychedelic psychiatry.
Despite this impetus, the FDA declined to approve M**A-assisted therapy in 2024.
10 Reasons Why The FDA Rejected M**A
10 Reasons Why The FDA Rejected M**A
Source: Mark Gold, MD, with permission
The FDA was less concerned with M**A's positive effects in PTSD but on methodological weaknesses, compromised blinding, psychotherapy standardization issues, safety-reporting limitations, therapist misconduct allegations, data integrity, and the durability and overall benefit–risk profile of M**A-assisted therapy.
Why Israeli PTSD Research Matters
Israel provides an important perspective through which to understand the next phase of M**A research. Israeli psychiatrists and trauma specialists have extensive experience treating combat veterans, terrorism survivors, and civilians exposed to chronic threat environments and have reported on treatments and outcomes from the Yom Kippur War. Israeli military psychiatry emphasizes immediate field assessment and proximity-based intervention following traumatic exposure, with the goal of restoring function early and reducing progression to PTSD.
Israeli researchers helped conduct some of the early studies of M**A-assisted therapy. However, even in Israel, M**A treatment is still tightly controlled and used mainly for patients with severe PTSD who have not improved with standard treatments.
What makes the Israeli experience especially important is its emphasis on functional restoration rather than symptom reduction alone. Israeli military psychiatry traditionally focuses on resilience, operational performance, interpersonal cohesion, immediate field intervention after traumatic exposure, and rapid return to military role/function. Israeli experts use M**A as a catalyst to temporarily reduce fear and defensiveness sufficiently to improve engagement with psychotherapy.
Why VA and DoD Studies May Become Decisive
After the president’s Executive Order, many believe the most consequential studies in the United States will likely occur within the VA and DoD systems. In contrast to smaller civilian psychedelic trials, the federal systems provide centralized medical records, standardized psychotherapy pathways, long-term follow-up, neurocognitive assessment, suicidality monitoring, and highly characterized trauma populations.
Importantly, military psychiatry evaluates outcomes differently from many civilian programs. The central question is not simply whether patients begin to feel better but whether they can function safely and effectively under high-stress military working conditions. Improved function is important, but resuming normal functioning is better.
Future Pentagon-backed M**A studies are expected to examine outcomes such as emotional control under stress, sleep restoration, cognitive performance, suicide-risk reduction, interpersonal functioning, return-to-duty capacity, and durability of benefit after repeated stress exposure.
These trials may also address several methodological weaknesses identified during the FDA review process. Standardized therapist training, tighter protocol enforcement, centralized adverse-event reporting, biomarker integration, and prolonged longitudinal follow-up may ultimately generate evidence that regulators view as more rigorous and reproducible.
Separating Psychedelic Medicine from the Illicit M**A Market
The Executive Order does not legalize illicit M**A, nor does it diminish ongoing public-health concerns. The 2025 Drug Enforcement Administration's National Drug Threat Assessment categorizes M**A usage as relatively low compared to drugs like fentanyl, methamphetamine, and co***ne. However, M**A remains widely abused by adolescents and young adults, produced by clandestine synthetic labs, and shipped to the U.S by transnational trafficking networks. The DEA warns that many substances sold as “Ecstasy” contain little or no M**A at all.
The distinction is critical. Pharmaceutical M**A research involves verified purity, known dosing, medical screening, and supervised administration. Illicit Molly or Ecstasy, by contrast, frequently reflects an unpredictable clandestine market with unknown pharmacologic composition.
The Future of Psychedelic Psychiatry
Psychedelic psychiatry is increasingly moving away from countercultural enthusiasm and toward large-scale federal research systems, randomized clinical trials, uniform protocols, formal regulatory scrutiny, biomarker-driven neuroscience, and longitudinal outcome analysis.