Barron’s: The First Phase 3 Success for Psychedelics Will Pave the Way for an Industry

Summary: Author Bill Alpert of Barron’s contrasts MAPS’ leading non-profit and public benefit models with the profit-oriented approach of new psychedelic companies. “None of the for-profits are talking about drug policy reform,” highlights MAPS Founder and Executive Director Rick Doblin, Ph.D.

Learn about the results of our first Phase 3 trial of MDMA-assisted therapy for PTSD in the context of MAPS’ decades-long efforts to advance psychedelic science.

Originally appearing here.

Post-traumatic stress disorder is a crippling, hard-to-treat psychiatric affliction. America spends billions of dollars yearly just on the veterans who suffer from PTSD. So it’s heartening to see the report of a promising new treatment, published Monday in Nature Medicine.

As the first Phase 3 trial of a psychedelic drug, the study is also at the forefront of a wave of excitement among therapists and investors in the healing potential of historically-outlawed substances like cannabis, psilocybin mushrooms, ibogaine and ayahuasca.

In Monday’s report, an international team of researchers describe their test of a treatment combining psychotherapy with doses of MDMA—the illegal drug popularly known as Ecstasy or Molly. The MDMA-assisted therapy was dramatically effective at reducing PTSD symptoms and improving daily functioning in the 42 treated participants, when compared with the 37 participants who got psychotherapy and a placebo drug.

Two months after their last drug-assisted session, two-thirds of the MDMA-treated patients no longer met the diagnosis for PTSD, compared with one third of those treated with placebos. While clearly significant in the patients’ lives, the difference was also highly statistically-significant.

The news lifted the stocks of most psychedelic drug development companies, even though they weren’t involved in the MDMA study—which was sponsored by a nonprofit organization. Shares of Compass Pathways (ticker: CMPS) rose 5% Monday, to $35.77, as the Nasdaq Composite dropped 2.6%. Field Trip Health (FTRPF) gained 13%, to $5.18. Mind Medicine (MNMD) slipped 6%, to $3. Awaiting effectiveness of its initial offering prospectus is Atai Life Sciences, a Berlin-based psychedelics enterprise that aims to raise more than $100 million in its Nasdaq IPO.

The MDMA study recruited 90 PTSD patients in the U.S., Canada and Israel. Their average age was 41 and had been diagnosed with PTSD for an average of 15 years. Over 90% also suffered from depression and had wrestled with suicidal urges. While PTSD is popularly-associated with war veterans, it’s more commonly found in women, and two-thirds of the study participants were female.

Treatment involved three preparatory psychotherapy sessions with a two-therapist team. Then the study participants had three eight-hour therapy sessions, after doses of either MDMA or a placebo. Psychotherapy continued after the drug-assisted sessions. The study was double-blinded, with outside raters measuring changes in the participants’ PTSD symptoms and daily functioning.

The U.S. Food and Drug Administration has approved only a couple of antidepressants as treatments for PTSD, and about half of PTSD patients get no relief from those drugs. But in the MDMA-assisted study, 67% of treated patients improved enough to no longer satisfy the diagnostic criteria for the condition, while a third enjoyed complete remissions after the three drug-assisted sessions. In its prescribed use, the MDMA caused no major safety issues.

The Nature authors speculate that MDMA-assisted sessions produce a “window of tolerance,” in which patients are able to revisit traumatic memories, with less shame and anger, and without being overwhelmed by PTSD symptoms. The treatment worked equally well for patients with histories of drug and alcohol abuse.

“When people see these results, there will be tremendous interest in it,” said Amy Emerson, the chief executive of the MDMA study’s overseer, the MAPS Public Benefit Corporation, told Barron’s. The unusual enterprise grew out of the three-decade effort of a nonprofit group called the Multidisciplinary Association of Psychedelic Studies (or MAPS), to overcome the medical and legal obstacles to scientific study of banned psychoactive drugs.

MAPS was founded by Rick Doblin in 1986, not long after the federal government banned Ecstasy. In the years that followed he stubbornly pulled together the millions of dollars in donations, and dozens of researchers and lawyers, needed to bring MDMA-assisted therapy to the Phase 3 finish line. “We’re the oldest start-up in the world,” Doblin joked to Barron’s.

Meanwhile, for-profit enterprises seem to be sprouting everywhere to develop psychedelic drug treatments—emboldened by the rolling reforms enjoyed by the cannabis industry. Doblin ruefully notes that the for-profit ventures have raised hundreds of million in the last couple of years, while MAPS still faces funding challenges.

MAPS will need hundreds of millions of dollars more, notes Doblin, who is now executive director. MAPS must complete a second Phase 3 study before the U.S. Food and Drug Administration considers approving the treatment. Then it must train therapists around the world to administer the treatment.

“For 32 years of our 35-year history, nonprofits like MAPS were the only way to go,” Doblin said. “There were no investors.” Doblin’s effort inspired other nonprofit drug developers, including the Usona Institute, which is running a clinical trial of psilocybin for treatment-resistant depression.

The nonprofit MAPS has big ambitions. It has sponsored studies of marijuana, LSD, ibogaine and ayahuasca, while lobbying for legalization of these substances as tested, licensed treatments. “None of the for-profits are talking about drug policy reform,” said Doblin. “Sometimes it takes the non-profit model to be innovative and touch things that the for-profits don’t want to touch.”


To finance the testing and rollout of MDMA-treatments, MAPS created a public-benefit corporation—a legal form of business venture that’s cropped up in the last decade, which prioritizes additional aims beyond profits, including a company’s impact on society, workers, and the environment. In the U.S., the MAPS public-benefit corporation will enjoy a five-year exclusivity for its MDMA-assisted treatment. The resulting revenue will fund training for therapists. CEO Emerson said that the company may also seek revenue as a contract research organization, running clinical trials for other psychedelic treatment developers.

About 1,100 therapists have applied to MAPS for training, said Emerson, and over 15,000 have asked to be notified of training opportunities.

“Now it’s the hot new thing,” said Emerson, “but we paved the way and made it easier, in a lot of ways, for the for-profit companies.”