Summary: Motherboard explores the role of psychedelics in science, politics, and culture. The article highlights MAPS as one of the leading organizations funding and supporting ongoing psychedelic research, investigating bureaucratic barriers associated with privately funding psychedelic research by speaking with Natalie Lyla Ginsberg, M.S.W., of MAPS. “All these extra burdens put on researchers like waiting for a Schedule I license, finding the right location, finding a manufacturer of the drug, add months or years to the process,” explains Ginsberg. “People who do psychedelic research aren’t just any old researchers—they have to be committed and willing to fight through the regulations and have patience to wait for months on end for approval. Rescheduling would release a lot of these barriers that exist only for Schedule I substances.”
Originally appearing here.
In 1988, Rick Strassman set out to do what seemed to be impossible: convince the US government to let him give people illegal drugs.
But not just any illegal substances. Strassman, a psychiatrist at the University of New Mexico, wanted to dose subjects with one of the most potent psychedelics ever discovered: dimethyltryptamine (DMT), a neurotransmitter and tryptamine molecule that naturally occurs in the plant and animal kingdoms, including in humans. Strassman hoped to investigate the physiological and psychological effects of DMT, the so-called “spirit molecule,” but knew that getting approval to do this research was a long shot.
Like pretty much every other psychedelic drug known at the time, DMT had been classified as a Schedule I substance under the 1970 Comprehensive Drug Abuse Prevention and Control Act. This meant that there was no recognized medical use for the substances and effectively placed a moratorium on all psychedelic research using human subjects. Studying and administering substances gets progressively easier as you move from Schedule I to Schedule V. Substances in Schedule I, including heroin, are the only ones, in fact, that require a special license to study.
But these obstacles didn’t deter Strassman. After 19 months of arduous paperwork and a seemingly interminable argument with the Drug Enforcement Administration, in early 1990 he dosed his first participant with DMT. It was the first psychedelic study using humans in two decades.
“I figured as long as the DEA weren’t saying no, it remained a potential yes,” Strassman told me recently. “I never really gave up.”
“‘I don’t care if you guys are smoking mushrooms back there, just keep out of the paper, get your grants and keep your cards close to your chest.'”
In the nearly three decades since Strassman’s groundbreaking DMT study, little has changed for researchers hoping to study the effects of psychedelic compounds on humans. Although psychedelic research is experiencing a sort of renaissance, getting approval to study these substances is more difficult than ever.
At the same time, recent work done on psychedelics has shown potential in treating everything from post-traumatic stress in veterans to promoting creative problem solving and treating addictions.
If the federal decision to classify these substances as having no medical value was premature, then understanding the benefits (and dangers) of psychedelics in a rigorous and empirical way has been hindered by bureaucracy and authorities policing research laboratories. I reached out to Strassman and contemporary clinicians to learn more about their experiences and the difficulties faced by psychedelic researchers today. Just how hard was it—is it—to get the greenlight from Uncle Sam?
That’s getting ahead. For most psychedelic scientists, problems begin at the local level.
To do science on humans with illegal substances, researches are required to submit a proposal to an institutional review board, which is supposed to ensure the experiment is both ethical and safe. Given the taboo surrounding psychedelics and universities’ tendency to avoid controversy, even the safest and most well-designed studies may flounder on the shores of a dean’s idea of what constitutes respectable science.
Fortunately for Strassman, he said the University of New Mexico was somewhat “off the beaten path,” and that his psychedelic study was much less likely to draw significant attention than if it had been conducted at an Ivy League institution. Moreover, Strassman said neither his department chair nor the university president really cared what he was up to in his lab, so long as he “kept his nose clean.”
Read More: America’s Trippiest Chemist Says Making Psychedelics ‘Was Fun’
“I spoke with the chairman of the research unit and he said, ‘I don’t care if you guys are smoking mushrooms back there, just keep out of the paper, get your grants and keep your cards close to your chest,'” Strassman remembered.
After gaining approval from the university, Strassman then had to make his pitch at the federal level, specifically the DEA and the Food and Drug Administration. The DEA was responsible for doling out Schedule I licenses, which authorized licensees to possess these illicit substances. The FDA, for its part, would give Strassman approval for what’s known as an IND, or Investigative New Drug trial, which would allow him to administer the Schedule I substance to human subjects.
There was only one problem: The DEA wanted to see the FDA’s IND license before granting its Schedule I license, and the FDA, in turn, wanted to see that Strassman was approved to use the Schedule I substance before granting the IND. It was a catch-22.
But as Strassman began to facilitate unprecedented degrees of contact between these two federal agencies, he realized he had a far more pressing problem to deal with: how to procure the DMT for the trials in the first place. In order to get his Schedule I license from the DEA, he would have to show that the DMT was pure, and that he would only have access to a limited and necessary amount of the substance.
Eventually Strassman linked up with Dave Nichols, a chemist at Purdue University with DEA approval to synthesize 15 Schedule I psychedelics and 20 years of experience doing just that. After finding a hookup for the DMT, Strassman returned to the DEA and started filling out the paperwork.
Several months later, Strassman had his Schedule I license and IND. It had been over a year-and-a-half of starts, stops, and red tape. But he was finally set to begin his research.
When Strassman was setting out, he had to rely on trial and error in his dealings with the feds, who were less than receptive to the idea of allowing Schedule I substances to be opened for research purposes.
The first paper Strassman wrote after receiving approval for his study was about how he managed to even make this happen—a kind of blueprint for getting approval to do psychedelic science. Although he was criticized for revealing hard-won, “sensitive” information about government legal processes, his blueprint was effective. According to Strassman, it helped guide researchers at the University of Arizona, University of Miami, and Johns Hopkins University set up their own studies on psilocybin (the psychedelic compound in “magic mushrooms”) and ibogaine in the late 90s and early 2000s.
But overregulation continues to crush psychedelic science. Even with Strassman’s blueprint and a number of precedents in place, getting approval to study psychedelics is still a steep challenge.
The Multidisciplinary Association for Psychedelic Studies (MAPS), for example, has been pushing the limits of psychedelic research for decades now, yet its trials on MDMA and PTSD keep stalling out in a maze of bureaucratic and legal obstacles.
MAPS hopes to begin the third an
d final FDA study this year, and to see MDMA be a FDA-approved prescription medicine by 2021. But the phase 3 study is also the most difficult since it requires special parameters for the trials, which include large cohorts of study participants as well as using chemicals produced under a Good Manufacturing Practices (GMP) regime. GMPs are mostly quality control measures, but since the MDMA used in the first two phases was already 99 percent pure, this means that GMP is mostly a regulatory requirement that places copious paperwork and protocols on the researchers for the duration of the trial phase.
“Rescheduling would release a lot of these barriers that exist only for Schedule I substances.”
This also means that MAPS will have to find a new source for its MDMA since the drug must be manufactured under GMP conditions. Even though pharma companies like Sigma-Aldrich have websites set up where you can order small quantities of every imaginable psychedelic, these won’t meet the phase 3 GMP requirements. Natalie Ginsberg, a MAPS policy and advocacy manager, said so far just finding a manufacturer for the stuff has been hard enough.
Then there’s the money problem. Historically, most psychedelic studies have been funded by the National Institute of Drug Addiction (NIDA). Although NIDA’s pockets run deep, the agency is particular about the kind of drug research it will fund—that is to say, only research that investigates the abuse potential of substances, not their therapeutic potential. As such, organizations like MAPS have had to seek private funding for studies, which, all told, will cost millions of dollars. The GMP MDMA alone will cost nearly $500,000 for 1.5 kilos.
In this respect, Strassman realizes he was lucky. For his DMT trials, he had secured two competitive grants to support him during the year-and-a-half it took to get approval just to begin his research. Without this grant money, Strassman said it’s unlikely he would’ve had the time or energy to pursue this research project.
Ultimately, he and Ginsberg see the difficulties faced by researchers as a consequence of the War on Drugs and its scheduling regime.
“All these extra burdens put on researchers like waiting for a Schedule I license, finding the right location, finding a manufacturer of the drug, add months or years to the process,” said Ginsberg. “People who do psychedelic research aren’t just any old researchers—they have to be committed and willing to fight through the regulations and have patience to wait for months on end for approval. Rescheduling would release a lot of these barriers that exist only for Schedule I substances.”
Strassman likewise said he’d like to see psychedelic substances rescheduled, though he realizes researchers are caught between a rock and a hard place. To keep psychedelics as Schedule I substances makes researching them prohibitively hard, but to call for reclassifying them as Schedule II substances is unlikely to succeed either.
Schedule II substances, including stimulants like cocaine and Adderall, can be prescribed by everyone from dentists to veterinarians. As Strassman sees it, trying to argue that something like LSD should be as easily accessible as Adderall is a non-starter. Instead, he advocates for a new, intermediate schedule between I and II, that would make the substances easier to study, but not absurdly easy for a layperson to obtain.
“I think that category of clinical reality ought to be combined with a legal category of the scheduling,” Strassman said. “People wouldn’t be able to possess and give these drugs without special training and without certification and supervision, but if you keep them kind of behind the lock and key of Schedule I, you’re also not going to be able to give them to people who might benefit.”