Summary: The Georgia Straight interviews psychedelic researchers from MAPS’ Phase 3 MDMA-assisted psychotherapy for PTSD clinical trial site in Vancouver, Canada. The British Columbia Centre on Substance Use (BCCSU) is one of 16 international locations gearing up for Phase 3 studies. Gerald Thomas, Ph.D. Kenneth Tupper, Ph.D., and Mark Haden, M.S.W., of BCCSU are interviewed about clinical trials of ayahuasca-assisted therapy for addiction, BCCSU’s plans for psilocybin-assisted psychotherapy for the treatment of substance abuse, and upcoming Phase 3 MDMA-assisted psychotherapy for PTSD. “It’s a larger-scale randomized-control trial,” explains Tupper. “And at the end of it, we believe, this is a hypothesis, but we believe it could generate sufficient data to move MDMA to become an approved medication for the treatment of PTSD.”
Originally appearing here.
In 2011, Gerald Thomas was invited to an Indigenous community in a remote area of British Columbia. Working for the Centre for Addictions Research of B.C., he was one of a small team of scientists who observed 12 people take ayahuasca, an Amazonian mixture that induces vivid visual and auditory hallucinations as well as deep emotional and intellectual reflection.
“The ceremonies themselves are really intense,” Thomas told the Georgia Straight in a telephone interview. “People are pushed to their emotional edge.”
The group remained in a longhouse and its surrounding forest for four days. They slept on its dirt floor and bathed in the nearby river. It wasn’t your typical experiment, Thomas conceded. At the same time, he explained how the team observed rigorous protocols for research involving human subjects.
“There were months of work getting ethics approval, designing the study, finding the instruments that we would use to collect psychometric data. Then, for four days, we were all holed up in a longhouse.”
Most of the 12 patients were victims of severe childhood trauma who struggled with addictions to a variety of drugs: alcohol, cocaine, and opioids such as heroin.
“One man described how, when they were kids, their parents would throw parties and the folks would get drunk and then wander upstairs and molest them,” Thomas remembered. “Can you imagine being in your own home, in your own bed, waiting? The terror, the confusion. Can you imagine what that would do to your psyche?”
Participants struggled with terrible memories and many years of drug abuse. In the longhouse, they delved into those issues. A shaman—an ayahuasquero—who had travelled to B.C. from Peru worked alongside a “retreat team” that ran group-therapy sessions and meditation.
Participants’ reactions were encouraging.
“When I went to this retreat, it more or less helped me release the hurt and pain that I was carrying around and trying to bury…with drugs and alcohol,” a 41-year-old female patient said, quoted in a report on the experiment. “Ever since this retreat, I’ve been clean and sober.”
“I got my spirit back,” a 49-year-old woman told researchers. “It’s so beautiful outside, and where was all that all this time? You know, I was just living with a black cloud over me. And the black cloud’s been removed.”
Positive feedback continued in follow-up interviews conducted during the next six months. “But we didn’t know what we actually had until we analyzed the data,” Thomas said. “Then we saw it.”
A 2013 paper Thomas coauthored for the academic journal Current Drug Abuse Reviewsdescribes the results: “Self-reported alcohol, tobacco and cocaine use declined, although cannabis and opiate use did not; reported reductions in problematic cocaine use were statistically significant.
“Given the potential to decrease the personal suffering and social costs associated with addiction, further research on ayahuasca-assisted addictions treatment is warranted.”
Five years later, very little further research has occurred.
Rigorous studies of psychedelic plants and chemicals are rare. It wasn’t always that way. Decades ago, scientists across North America eagerly investigated the clinical benefits of psychedelic and otherwise psychoactive substances. They were fascinated with mescaline, found in the peyote cactus; psilocybin from so-called magic mushrooms; and lysergic acid diethylamide, better known by its acronym, LSD. And they were making progress. Then, in 1970, the U.S. government classified all three as Schedule I narcotics, grouping them in with hard drugs like cocaine and heroin. Officially, they had “no currently accepted medical use in treatment”. Investigations into how psychedelic drugs might help people with disorders such as depression and alcoholism halted.
Almost half a century later, a psychedelic renaissance of sorts is under way. Reputable scientists working for prestigious institutions are increasingly paying attention to these drugs.
Kenneth Tupper is a director at the B.C. Centre on Substance Use (BCCSU). He previously worked in drug policy and harm reduction for the B.C. Ministry of Health, but his passion is psychedelics. Their “educational and cognitive value” was the subject of his master’s thesis, and his PhD dissertation for UBC is a 348-page paper on ayahuasca and public policy. Tupper also worked on the ayahuasca review of which Thomas was the lead author. Now he’s part of a team the BCCSU has assembled to put Vancouver at the forefront of this renaissance.
“Psychedelic plants and drugs have been used for thousands of years in traditional healing and spiritual ceremonies, and contemporary western science has not paid them much attention,” Tupper told the Straight. “Now there’s new interest in these traditional practices, as well as interest in bringing a clinical, scientific approach to the substances contained in these plants.”
One reason this is exciting, Tupper continued, is that many of the areas where psychedelics look most promising are ones where pharmaceutical medicines long ago hit a wall, areas like posttraumatic stress disorder (PTSD), depression and anxiety, eating disorders, and dependence on drugs and alcohol.
The question of addiction is an especially urgent one. In 2017, more than 1,400 people in B.C. died of an illicit-drug overdose. In the United States, that number exceeded 64,000 in 2016. An overdose is now the leading cause of death for Americans under the age of 50. The majority of cases lead back to a dependence on opioids: OxyContin, heroin, or fentanyl.
“Opioid addiction is a challenging one to treat, and whether this intervention is going to be helpful, we have yet to see,” Tupper said. “But we want to try.”
A long and strange tale
The story of how research concerning psychedelic drugs fell out of favour in North America and then only recently regained some legitimacy is a long and strange tale.
Parts of it are well-known. In 1943, a Swiss chemist named Albert Hofmann inadvertently ingested LSD and discovered that it stimulated hallucinations. In the 1960s, an American psychologist named Timothy Leary spread word of its therapeutic and recreational potentials with the zeal of a preacher. Rock ’n’ roll legends like John Lennon and Jimi Hendrix led youths to embrace the drug. Another musician, Charles Manson, caused the general public to fear it.
According to Erika Dyck, Canada Research Chair in the history of medicine at the University of Saskatchewan, Canada played an underappreciated role
in this story.
In a telephone interview, she began her story in 1951, when an English psychiatrist named Humphry Osmond responded to a want ad for a job at Weyburn Mental Hospital in Saskatchewan. Upon moving to Canada, Osmond connected with Aldous Huxley, a British author then living in America who two decades earlier had gained considerable fame with the publication of a dystopian novel called Brave New World. Huxley introduced Osmond to mescaline and other psychedelic drugs, and the two forged a close friendship.
In 1956, they searched for a name for this category of substances that had so captured their imaginations. In letters, Osmond and Huxley traded words and debated their meanings and Latin roots.
“To make this trivial world sublime, take half a gramme of phanerothyme,” Huxley wrote in April that year.
To which Osmond replied: “To fathom Hell or go angelic, just take a pinch of psychedelic.”
Meanwhile, Dyck continued, closer to Vancouver, a facility in New Westminster called Hollywood Hospital began using LSD and mescaline in the treatment of alcoholism.
“This was an elite, private facility where people could pay to get a safe space to experience a psychedelic,” Dyck recounted. “There’s a lot of glitz and glamour and it’s shrouded in these really fantastic rumours.”
Dyck, who’s been working with Hollywood Hospital’s patient files, described how at 525 West 6th Street, Dr. J. Ross MacLean treated patients with psychological exams, counselling, and between 50 and 250 micrograms of LSD.
“And they would talk about these really sacred moments,” Dyck said. “Sometimes with profound insight into a piece of trauma that they had experienced.”
Hollywood Hospital’s results were promising. “Publications from there and other collaborating units suggested between 50- and 90-percent recovery rates,” Dyck said. But by the late 1960s, psychedelic drugs and researchers paying them attention were becoming badly stigmatized.
Across the country, at the Allan Memorial Institute at McGill University in Montreal, another group of researchers was working with LSD using very different methods. Under the leadership of Ewen Cameron, and with financial support from the CIA, patients were administered LSD without their knowledge and often under conditions of sensory deprivation or repetitive stimulation. The program, which the CIA code-named MKULTRA Subproject 68, became public in a high-profile lawsuit and badly tarnished psychedelics research across North America.
“All of those things emerging in the media spotlight in the 1970s really threw a dark shadow on some of the earlier research,” Dyck said. “There was increasing pressure on researchers around the world to stop using LSD.”
Psychedelic drugs had also become associated with counterculture movements that were upsetting the status quo. Then, in August 1969, LSD and psilocybin were on display at the Woodstock festival, where they appeared to lead to dancing. The same month, Manson gave LSD to members of his cult following and they carried out a string of murders in and around Los Angeles. The nation was captivated and horrified. Less than one year later, the U.S. government made most psychedelics Schedule I narcotics. In Canada, they were placed under the Narcotic Control Act. Sanctioned medical experimentation effectively came to an end.
Psychedelic renaissance
For almost half a century, the field lay dormant. Then, slowly, through the 1990s and early 2000s, academics’ interest perked and papers began to trickle forth. A full-blown “re-emergence of a paradigm”, as one paper describes it, is now under way.
A 2014 article published in the Journal of Nervous and Mental Disease described how a team in Switzerland found that LSD may help terminally ill patients cope with anxiety associated with death. A 2015 paper in the Journal of Psychopharmacology shared impressive results from a proof-of-concept study where psilocybin was used to treat alcohol dependence. A 2016 paper in the Lancet Psychiatry reported that patients who struggled with moderate to severe depression were administered psilocybin and, as a result, “depressive symptoms were markedly reduced.”
Other projects have sought to explain the clinical effects that those sorts of studies associate with psychedelic drugs. A 2016 paper in the Proceedings of the National Academy of Sciences, for example, described how neuroimaging tools revealed how the brain and nervous system responded to LSD and how those changes appeared to correlate with states of well-being that patients reported after taking the drug.
Dozens more papers have appeared in equally reputable journals during the past decade. The studies are generally characteristic of a field of research still in its infancy: their sample sizes are small; they sometimes lack control groups; and experiments are often not “double-blind” or “blind” (an experimental-standard procedure that hides information in order to prevent bias but is difficult to apply to psychedelic drugs because their effects are so obvious). But now a second period of research is under way wherein academics are expanding sample sizes and building on that earlier work. And scientists in Vancouver have positioned themselves at the front of the field.
The B.C. Centre on Substance Use was established in April 2017 under the leadership of Dr. Evan Wood. At a café across the street from St. Paul’s Hospital, Wood described the team he’s brought together.
“Kenneth Tupper probably brings the most knowledge from an academic perspective,” Wood began. “Mark Haden has come on to help.…Cody Callon is coming at this as a highly experienced researcher.…Katrina Blommaert was the lead study coordinator for a prior MDMA study.…and Dr. Keith Ahamad is experienced in conducting clinical research with the U.S. National Institute on Drug Abuse’s clinical-trials network.”
Wood acknowledged there is a lingering stigma around psychedelic drugs. He noted that funding remains a challenge. (“I’m at the ready to help philanthropists and possible donors understand the nature of the work and why we believe this is a critically important research area,” he added.) But Wood said they’re taking a “science-driven and evidence-based” approach, the same as the BCCSU would for any field of research.
“The potential here is enormous,” he said. “So we’re going to do studies in a way that will stand up to the highest level of not only ethical scrutiny but scientific scrutiny. That’s the only way to move forward things that are in controversial areas.”
In a separate interview, Tupper revealed the team’s first project: a clinical trial that will begin later this year to examine the effectiveness and safety of MDMA-assisted treatment for PTSD. That is, they’re going to study ecstasy, or molly (though street drugs sold under those names are usually cut with other substances unknown to the buyer, whereas the BCCSU’s MDMA will be pure).
The BCCSU will serve as one of 16 locations across Canada, the United States, and Israel where teams will work on the same experiment under the guidance of the Multidisciplinary Association for Psychedelic Studies’ (MAPS) MDMA-Assisted Therapy project. It’s a so-called Phase 3 clinical trial, which is normally the last phase of review a drug receives before it is approved for public use. Only 25 to 30 percent of drugs that enter Phase 3 pass successfully. But MAPS’s Phase 2 review was promising. Concluded in 2016, it found that one year after participants diagnosed with PTSD were given MDMA, 68 percent no longer experienced symptoms. Phase 2 result
s were based on 107 participants. The goal for Phase 3 is for more than 200 patients to complete the study, approximately 18 of whom will do so at the BCCSU.
“It’s a larger-scale randomized-control trial,” Tupper said. “And at the end of it, we believe, this is a hypothesis, but we believe it could generate sufficient data to move MDMA to become an approved medication for the treatment of PTSD.”
However, Tupper added, “It wouldn’t be like ‘Take two and call us in the morning.’ ”
Similar to the ayahuasca ceremony that Tupper reviewed in 2011 and the earlier experiments with LSD at Hollywood Hospital, he explained, the MAPS Phase 3 review of MDMA will see it administered in highly controlled settings where two therapists are present and engage each participant to establish a strong therapeutic relationship.
“The therapists sit with the patient in the clinic space for the duration of the effects of the medication, which is about eight hours,” Tupper said. “Then, once the session is finished, they actually stay overnight for monitoring. And then they have subsequent sessions with the therapist team over the next couple weeks.”
Actual work with patients likely won’t begin until mid-2018, but Tupper said the BCCSU is already preparing for its second foray into psychedelics: psilocybin for the treatment of substance-use disorders.
“We’re going to be looking for people with alcohol-use disorder, stimulant-use disorder, and opioid-use disorder,” Tupper said. “We’re not sure whether psilocybin will be as effective with one versus another. It’s an open scientific question right now.”
Addressing the root of a problem
Another open question is exactly how psychedelic drugs like MDMA and psilocybin work to help correct the problems that researchers suspect they do. That’s in part because we don’t fully comprehend the problems themselves.
Modern science can usually explain how a medicine works to heal a physical ailment. For example, antibiotics resolve a bacterial infection by killing those microorganisms or inhibiting their growth. But ailments like PTSD and addiction are problems of the brain—disorders that we generally know much less about.
Before joining the BCCSU, Mark Haden established a MAPS presence in Canada and served as its board chair for the Vancouver portion of the MAPS Phase 2 review of MDMA. That study marked the first time a psychedelic drug received a proper clinical review in Canada in more than 40 years. In a telephone interview, he explained what we know and don’t know about how MDMA could assist people with PTSD.
“It’s a very complex question,” Haden began. “For MDMA, let’s go back a notch: what is PTSD? PTSD is an unconscious tape loop that repeats itself and is associated with emotional distress.
“It is expressly distressing because it is a process that is unconscious, therefore you don’t have control over it,” he said. “It is associated with fear.”
Taken in a therapeutic setting, Haden continued, MDMA can help address those symptoms.
“MDMA creates a physical-relaxation response, and so fear is reduced. It also reduces permeability between the conscious and the unconscious mind. It gives people access to parts of themselves they don’t normally have access to,” he said. “MDMA specifically is also an empathogen. It’s an alliance builder. And the greatest predictor of success of any therapy is the alliance between the therapist and the person who is seeking the therapy.”
Haden suggested that, more broadly, it’s about addressing the root of a problem. With psilocybin and addiction, he hopes the same principle will be found to apply.
“We would like to start to work with people in a way that is about dealing with underlying issues,” he said. “The larger view of drugs that only sees them as something that needs to be criminalized has failed us all miserably. And so now we’re approaching this with a more nuanced view.”
