In the U.S., the Drug Enforcement Agency (DEA) holds the keys when it comes to accessing research-grade schedule I drugs. Labs and scientists submit their applications to the agency, describing their hypothesis, the processes they plan on using to execute their study, their sources of funding, and explaining the scientific backgrounds of the researchers involved.
Historically, few are approved for the research. But those that are, like the Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation, receive DEA clearance to order testing samples from one of the DEA’s schedule I licensed drug manufacturers, like the National Institute on Drug Abuse (NIDA). According to Allson Coker, the regulatory affairs manager at MAPS, the DEA essentially acts as the middleman between producers like NIDA and scientific consumers like MAPS—what’s known on the streets as a “dealer.”
“But [they’re] not a very good one,” she quips with a chuckle.
Because so few of the research applications have been approved in years past, licensed schedule I manufacturers typically only produce small quantities of these drugs annually. But heading into 2022, the DEA has asked their manufacturers to up the hallucinogenic quota: by 6,300 percent for MDMA, 1,570 percent for 5-MeO-DMT, 1,150 percent for LSD, 500 percent for regular DMT, 400 percent for mescaline, and 100 percent for psilocybin, psilocin, and tetrahydrocannabinol (THC).
Between MAPS’ groundbreaking trial of MDMA-assisted psychotherapy from earlier this year and the emergence of psychedelic research groups all over the country, a mortal crack might be appearing in the psychedelic levee. And the DEA is preparing for the subsequent surge of research.
“It’s kind of like a snowball effect,” says Coker. “We’re seeing more and more trials get published, and more psychedelic companies are taking an interest, more university programs are taking interest as they get more positive results, and more people are following the work and believe that there is potential here.”
MAPS has been pioneering psychedelic research science since 1986 with a mission to “create safe and legal opportunities for the uses of psychedelics in society.” On that front, MAPS has moved the needle further than any other nonprofit (or, for that matter, for-profit) organization.
In October, just six months prior to the DEA’s massive drug request in the Federal Registrar, MAPS published the first ever phase three trials of MDMA-assisted psycho-therapy for PTSD. The experiments—MAPP1 and MAPP2—were randomized, double-blind, placebo-controlled, multi-site clinical trials assessing the safety and efficacy of MDMA-assisted therapy. They used 200-300 participants, all suffering from severe PTSD from a variety of causes.
The results of those trials were a milestone by any scientific measure, according to Coker.
“The level of significance here was astonishing,” says Coker. “A lot of drugs get approved on very small margins of significance . . . but this was a very large effect, that was highly significant.”
The MAPS study concludes, “MDMA-assisted therapy induces rapid onset of treatment efficacy, even in those with severe PTSD, and in those with associated comorbidities including dissociative PTSD, depression, history of alcohol and substance use disorders, and childhood trauma.”
(MDMA—aka Molly, aka Ecstasy, aka 3,4-methylenedioxymethamphetamine—for the unfamiliar, is a synthetic psychoactive drug developed in 1912 by the drug company Merck, used throughout the 1970’s for psychotherapy, and which became a popular party drug in the 1980s. It induces powerful feelings of euphoria, higher self confidence, deeper empathy, mild hallucinations, and heightened sensations like color, touch, and sexuality.)
At the end of MAPS’ 18-week trial, 88 percent of the subjects who received controlled and supervised MDMA-assisted therapy sessions experienced a “clinically significant reduction” in their PTSD symptoms, according to the study. And 67 percent were so positively affected, they no longer even qualified for a PTSD diagnosis.
Coker also points out, on top of the MAPS research, a lot of universities and for-profit companies are getting serious about studying psychedelics. Johns Hopkins opened a psychedelic research center in 2019, and Berkeley launched its Center for Science of Psychedelics in 2020; then, in 2021, UCSF launched the Neuroscape Psychedelics Division, Mount Saini launched the Center for Psychedelic Psychotherapy and Trauma Research, UM launched its Psychedelic Collaborative, and NYU started its Langone Center for Psychedelic Medicine.
All of those will require schedule I psychedelic drugs to conduct their research.
“All of those will require Schedule I licenses with the DEA,” Coker adds.
Scientific demand for hallucinogens is skyrocketing, and the DEA is making arrangements to meet it. This means a watershed year for psychedelic research could be on the horizon—one that could generate a lot of medical and therapeutic reasons to deschedule, decriminalize, or even legalize these substances.
“We haven’t been able to demonstrate medical uses of [schedule I drugs] without research,” Coker says. “And so right now, people are more willing to look at this research and say, is there a use? Is it safe? Like let’s actually collect systematic data.”
