In 1982, a young psychedelic researcher studying at the New College in Florida embarked upon a month long workshop with the godfather of psychedelic medical research Stanislav Grof at the legendary Esalen Institute in Big Sur, California. It was here that this young man first learned of a drug called MDMA, still legal at the time. Little did he realize that this would be the beginning of a lifelong quest to legitimize a drug in the eyes of a world in which it would soon become taboo. This journey would take over 35 years …
In person Rick Doblin is an unassuming, short, scruffy-haired man – friendly and enthusiastic with a razor-sharp intellect. In December 2017 he was in Australia to discuss his work at the Entheogenesis Australis Psychedelic Symposium, Australia's most important conference on psychedelic medicine and research. Seven years ago, Doblin appeared at the same conference as keynote speaker. Back then he spoke inspiringly about how far the research community had come in bringing MDMA back into therapeutic contexts, but even in 2010 it still felt a little like a pipe dream. Despite its resounding positive clinical applications, was the world ready to turn "ecstasy" into a prescription drug?
In 2017 Doblin stood before the Entheogenesis Australis audience and proudly announced the FDA's recent decisions to both move the research into final Phase 3 stages, and to label the treatment with the important "Breakthrough Therapy" designation. It was a triumphant moment, but for Doblin it was the fruit of over 30 years work battling bureaucracy, institutional prejudices, and stifling political conservatism.
In the beginning, there was Adam
3,4-Methylenedioxymethamphetamine, or MDMA, was first synthesized by German pharmaceutical-chemical company Merck in 1912. The company was relatively disinterested in the compound and it sat in the annals of unexplored chemistry for decades until the 1950s, when it sporadically started to appear in various experiments.
Despite rumors the drug was being used recreationally in Chicago in the early 1970s it wasn't really until iconic American pharmacologist Alexander Shulgin began his own personal experiments in 1976 that the drug truly emerged. Shulgin was relatively disinterested in the drug, referring to it as like a ''low-calorie martini." But he did recognize the drug's potential therapeutic applications and introduced a psychotherapist friend, Leo Zeff, to it in 1977.
Zeff had already worked blending psychoactive drugs with psychotherapy and was 65 years old at the time, but he became so deeply inspired by the potential of MDMA that he turned into a psychedelic preacher. He postponed his retirement and traveled the country spreading the word of MDMA amongst scores of psychotherapists. It was rumored that Zeff ultimately worked to "train" around 4,000 psychotherapists in the therapeutic use of MDMA over the following few years. Zeff also coined the early euphemistic name for MDMA, "Adam" – in reference to the way the drug reverts the user into a "primordial state of innocence."
The mistakes of the counter-culture
Born in 1953, Rick Doblin missed those primordial and dynamic days of the late 1950s and early 1960s, when LSD was still legal and used in medical circles. By the time he came of age the drug was already illegal and beginning its early stages of demonization. It was too late to explore any potential medical uses. The powers-that-be had drawn a line in the sand and good luck to any serious scientist who wanted to work with the compound.
Doblin recognized in the early 1980s that he was living through a time similar to that of the early 1960s. MDMA was slowly but surely being successfully utilized and explored in medical and therapeutic circles, while simultaneously spiraling out into the recreational arenas that would inevitably bump up against the attention of the authorities. Doblin wanted to learn from the past and try to avoid history repeating itself.
"I do not think the use of psychedelics in the 60s was a mistake, nor do I think the alignment of psychedelics with the anti-war movement was a mistake," explains Doblin. "I think what was a mistake was the self-identification as counter-culture and that separation is self-defeating. Why have there been decades of suppression of psychedelic research? It's because in the 60s psychedelics became linked with symbols of cultural rebellion. President Nixon called Timothy Leary the most dangerous man in America."
So the plan was clear. Try to turn on as many mainstream "legitimate" voices to the benefits of MDMA before the narrative completely turned it into a demonized illegal drug. Doblin worked to educate many prominent voices on the effects of MDMA with a view to influence several religious scholars. As the unavoidable DEA crackdown began to loom in 1984/85 the pro-MDMA media campaign kicked into gear.
"We were upending the stereotypical drug users," says Doblin, as big news articles started to appear, with quotes from unexpected, and prominent, religious figures. Brother David Steindl-Rast, a Benedictine monk "seeded" by Doblin at a conference described the drug in the LA Times as, "like climbing all day in the fog and then suddenly, briefly seeing the mountain peak for the first time."
Schedule 3, 2, 1
Across 1985 there were four DEA public hearings planned to evaluate the looming criminalization of the drug. The DEA was apparently unaware of MDMA's medical usages, but the broader media attention on the drug had an unintended side effect. Thousands of people who had never heard of the drug were now discovering it, and citing the quickly escalating street use, the DEA announced an emergency hearing in May 1985. By July the drug was classified Schedule 1.
Schedule 1 is the highest level of restriction a drug can attain in the United States. To be classified Schedule 1 a drug needs to hold a high potential for abuse, have no accepted medical use, and show a lack of accepted safety. Heroin, for example, is a Schedule 1 drug. Cocaine, Oxycodone, and Fentanyl are Schedule 2 drugs.
"We were able to present enough evidence about the therapeutic benefits that the judge said it should be Schedule 3, meaning that psychiatrists should be able to still work with it but the administrator of the DEA rejected the recommendations and it was criminalized, even though we won several more times in the appeals court," Doblin says of these frustrating early developments.
In 1986 Doblin founded the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization that was initially created with the express intention of sponsoring scientific research to help pass MDMA into a FDA-approved prescription treatment. It took Doblin six years to get a small Phase 1 pilot study through and this was just to prove the drug was safe to administer. It was another 12 years before a Phase 2 study examining its efficacy was allowed. In the meantime MDMA became one of the most popular recreational drugs on the planet, known as "ecstasy" in the 1990s and "molly" in the 2000s.
From ecstasy to medicine
So how do you bring a drug back into clinical credibility after it has crossed over into taboo recreational territory? First you need to win the PR battle, and to do that MAPS began to focus its energy on exploring the positive medical uses of MDMA, specifically for PTSD in war veterans.
"If you were to design the perfect drug to treat PTSD, MDMA would be it," Doblin recently told the Washington Post. And there is nothing more cleverly mainstream than to be seen "helping our troops." As Doblin states later in the same interview: "We wanted to help a population that would automatically win public sympathy. No one's going to argue against the need to help them."
Once the remarkable results from the Phase 2 studies began to filter out no one could deny the treatment's incredible potential. The results of various worldwide trials targeted at patients with treatment resistant cases of PTSD showed that 55 percent of subjects were free of symptoms after two MDMA therapy sessions. The numbers increased to 61 percent after three sessions.
Even more exciting were the long-term follow up studies showing that, instead of the effect of the treatment waning over time, it actually increased, with some subjects taking longer to exhibit positive responses. Twelve months after treatment a stunning 68 percent of subjects, who were classified as especially extreme and treatment-resistant, were considered free of any PTSD symptoms. This compared to a placebo control displaying an expected success rate of 23 percent. There was no doubt about it, MDMA was proving to be a remarkable PTSD treatment.
Doblin describes one of the trial's success stories, a veteran of the Iraq war, who after two tours returned to the United States with major PTSD, characterized by uncontrollable rage. Revealing footage of the veteran taken during one of the MDMA treatment sessions shows the man gently undergoing a revelatory moment guided by two therapists.
"I really feel so much more at peace with everything," the veteran quietly confesses during a treatment session. "Even when I try and think about Iraq I somehow feel … really peaceful about the fact that that's my journey."
Six years later and that veteran is reportedly still holding onto those MDMA-guided sensations, revealing that these rich experiences are anything but fleeting.
"We basically have a three and a half month process, 40 hours of therapy, three MDMA sessions, three-to-five weeks apart," says Doblin, explaining the general treatment procedure of these trials. "The sessions are eight hours long, people spend the night in the treatment centre, then the next day they get several hours of integrative psychotherapy with a male-female co-therapy team. And after people go home, they have a phone call every day for a week just to check in."
Phase 3
After the FDA examined these Phase 2 results it not only pushed the research into Phase 3, but remarkably granted the treatment a Breakthrough Therapy Designation. The first Phase 3 trials, the final necessary step before ultimate legal approval, will commence in mid-2018.
Once these Phase 3 trials have commenced the MAPS team is planning to apply to the FDA for something called "Expanded Access". This program allows patients access to the treatment before it is officially approved. So while the Phase 3 trials will only be accommodating a few hundred patients, there are already reportedly over 20,000 patients who have expressed interested in the treatment through the MAPS website.
"We can essentially have psychedelic clinics opening up throughout the United States in the summer of 2019, prior to 2021, which is when we think we will have MDMA approved as a medicine," says Doblin.
The extent of what is about to be achieved cannot be understated, as Doblin sees psychedelic clinics being rolled out across the United States on a massive scale. From the 6,000 hospice centers to the 14,500 drug treatment centers currently existing in the country, Doblin suggests all these venues could easily house a psychedelic therapist using MDMA to treat patients for a variety of conditions.
The MAPS team is even meeting with the DEA to prepare the government organization for the influx of Expanded Access applications asking for Schedule 1 licenses. Doblin jokes, "I'm not so surprised they are letting us in, but I'll be surprised if they let us out."
MDMA by prescription
Once approved there is no way the FDA can control whether physicians deploy the drug for off-label uses, but MAPS has cleverly built in a series of protections to hopefully fend off any potential for abuse that could harm, or even reverse, the progress made.
"Unlike other drugs, the only people that can prescribe MDMA are therapists we have trained", says Doblin. "And they can only administer it under direct supervision in special clinics. It's never gonna be a take home drug."
The training program to become a licensed psychedelic therapist is relatively expansive, involving an initial online course, then a week-long in-person training camp before a full supervised initial patient treatment session. MAPS has also received approval to give therapists an MDMA dose as part of their training, so these applicants can better understand the experience a patient will undergo. Doblin adds that this last requirement will only be optional as he doesn't believe any therapist should be forced to take a drug if they choose not to.
Now what?
The FDA is interestingly requiring MAPS to initiate a study of MDMA psychotherapy for PTSD in adolescents. Called Phase 4, the subsequent research is designed to examine the effects of the treatment in children and Doblin is excited by the prospect of this next stage.
"For traumatized children the sooner you can treat them the better. Why wait until they become adults and have a horrible adolescence, then it's even harder to treat them. We will be using smaller doses and trying to figure out exactly how to do it."
All this MDMA/PTSD work is only a precursor to Doblin's larger gameplan, the legitimization and mainstreaming of psychedelics. One of the more extraordinary directions in which Doblin wants to take his MDMA research is to explore how psychedelics can be utilized to essentially solve some of the world's big problems.
"We're moving into the use of psychedelics for conflict resolution, between Arabs and Israelis, between Catholics and Protestants. We're just in the very early stages of conception, thinking about how to design a protocol, how to work with people from different sides of issues. Whether they all have to have their own individual experiences first so they know what they're getting into and then you bring them into a group setting. The point is that the renaissance in psychedelic research is now going well beyond neuroscience, well beyond individual therapy, into religion, spirituality and soon into conflict resolution."
It's undoubtedly a wildly improbable and ambitious plan, but if Doblin's track record is anything to go by then these are words worth paying close attention to. After almost 35 years of prohibition, MDMA is soon to be available by prescription, and once this door is open it's not hard to be excited about the possibilities that could come.
More pragmatic future clinical uses for MDMA already being trialled include treating anxiety about oncoming death in patients with terminal illness, and increasing social adaptability in autistic adults. MDMA is also being explored in conjunction with psychotherapy to treat alcohol addiction and an exciting clinical trial is currently underway in the UK.
After several decades in the wilderness, psychedelic medical research is again starting to flourish. From LSD-assisted psychotherapy to an ever-growing list of medical marijuana uses, previously demonized recreational drugs are being reevaluated for their potential clinical benefits. It's unclear where this may all end up but at the very least, what we know for sure, is that thanks to Rick Doblin, MAPS, and thousands of determined researchers, we will soon be able to use MDMA to markedly improve the lives of millions of PTSD sufferers, and that is no small achievement.
Photo credit: Orlando Sydney
