Summary: Mashable explores the recent revival of research into the therapeutic benefits of psychedelics including psilocybin, LSD, and MDMA. The article highlights MAPS’ upcoming Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). “The FDA could potentially approve MDMA for medical use in as little as five years,” reports Maria Gallucci of Mashable.
Originally appearing here.
After learning in 2010 that she had Stage 1 ovarian cancer, Dinah Bazer felt optimistic. Her doctors had just removed the grapefruit-sized tumor bulging from her belly and started her on a course of chemotherapy.
“I thought, when the chemo is over, we’ll celebrate,” Bazer, who is now 69, recalled. “But it was the exact opposite.”
Bazer’s cancer was in remission, yet she felt terrified by the possibility of its return. Every check-up filled her with dread. She gained weight stress-eating bags of Halloween candy in her Brooklyn home. The upbeat spirit she’d shown her husband and two grown daughters was completely gone.
Her downward spiral lasted until the fall of 2012, when she participated in a unique medical trial at New York University’s Langone Medical Center.
The trial involved taking a single dose of psilocybin—a key compound in hallucinogenic mushrooms—under a therapist’s supervision. Researchers at NYU were exploring whether the drug could help ease existential depression in people with life-threatening cancer.
Bazer took the psilocybin in October. Over four years later, she remains transformed.
“I saw my fear; it was a black mass under my rib cage. And I was just furious to see this thing there,” she remembered of the experience. “I screamed at it, ‘Get the fuck out! I won’t be eaten alive!’ As soon as I did that, it was gone,” Bazer said.
“That lack of fear… has stayed with me.”
The NYU trial is among a growing number of studies exploring the therapeutic benefits of mind-altering compounds like psilocybin and MDMA (a.k.a. ecstasy or molly).
Psychiatrists around the world say there’s early evidence that these psychoactive— and widely illegal—drugs can help treat people suffering from cancer-related anxiety, post-traumatic stress disorder (PTSD), and addictions to alcohol, nicotine or cocaine.
That isn’t to say that rolling on molly or eating mud-crusted ‘shrooms will deliver the same results, or are inherently a safe decision.
But, researchers say, when taken in a controlled setting, and combined with therapy, these compounds could provide a potent and very real alternative to today’s treatment options.
When standard treatments don’t work
Psychotherapy, for instance, doesn’t work for many PTSD patients. Common anti-depressant medications carry a range of side effects, like insomnia, loss of sexual desire, weight gain and suicidal thoughts.
“There’s a real unmet need for people who can’t tolerate the standard treatments,” said George Greer, a psychiatrist in New Mexico and medical director of the Heffter Research Institute, the main funder of psilocybin research.
This expanding research area saw two important advances last week alone.
On Nov. 29, the U.S. Food and Drug Administration (FDA) said researchers could move forward with a large-scale, Phase 3 clinical trial for ecstasy-related therapy with PTSD patients.
Two days later, NYU and the Johns Hopkins School of Medicine published positive results from separate Phase 2 trials testing psilocybin treatment for cancer patients.
If all continues to go well, the FDA could potentially approve MDMA for medical use in as little as five years, and psilocybin in around a decade, researchers told Mashable.
Recreational drug use concerns
While there’s wide support for renewed research on these compounds, worries about their use persist.
Some experts argue that these kinds of studies send a dangerous message to the public that mind-altering drugs are safe for recreational use.
Ecstasy can cause high fevers and cardiac arrest. Studies show prolonged use may cause brain damage. Among mushroom users, about 10 percent of people put themselves or others at risk of physical harm while under psilocybin’s spell, according to a new Johns Hopkins survey published with the cancer studies.
“One has to be very cautious in moving forward, in terms of medicalizing this class of drugs,” said Bertha Madras, a professor at Harvard Medical School’s psychiatry department, and a psychobiologist at McLean Hospital.
“If there is a perception among youth that it’s a medicine,” she told Mashable, “we’re going to trigger a cascade of unintended consequences that will have far greater impact than the few people that have been helped in clinical trials thus far.”
From taboo to trials
Plenty of research gains on psychoactive substances have been made in just the last decade—though testing of some of these drugs began long before.
Scientists began studying the drugs’ potential medical benefits in the 1950s. Even the U.S. military explored the use of MDMA and the hallucinogenic LSD for treating soldiers.
But by the 1970s and ’80s, the mind-altering substances had wound up in too many people’s hands, and concerns of bad trips and brain damage spread. Governments cracked down, and federal research dollars disappeared.
Psilocybin, MDMA and LSD are all listed as Schedule 1 substances under the U.S. Controlled Substances Act. The federal government ruled these compounds as having no accepted medical use, and lack accepted safety measures for use under medical supervision.
The latest research aims to prove those findings wrong.
Roland Griffiths, a psychiatry professor who led the psilocybin trial at Johns Hopkins, said he started studying the compound because he was deeply curious about its conscience-expanding properties.
In 2000, he spearheaded the first FDA-approved clinical study in decades that tested psilocybin in healthy volunteers, who were carefully screened and prepared.
Early trials showed psilocybin could produce “deeply personal meaningful experiences, to which participants attribute enduring positive changes in attitudes, moods and behaviors,” Griffiths said.
The Johns Hopkins team next focused their research on cancer patients suffering from crushing existential anxiety. NYU researchers held similar clinical trials around the same time.
According to the research published Dec. 1, about 80 percent of participants in both studies showed clinically significant reductions in depression and anxiety that lasted more than six months.
Some participants had disturbing hallucinations or experienced nausea or vomiting, but nobody was made worse off by the treatment.
Bazer remembered feeling frightened at the start of her experience with psilocybin, which followed weeks of preparation with her therapist, Anthony Bossis. That day, she slipped on an eye mask and wore headphones playing soothing music.
“I was just tumbling in space, in the hold of a ship that’s rocking in a stormy sea alone,” she said. Bossis held her hand and encouraged her to “just go with it.”
That was when she expelled the black mass of fear. She floated in the music. She saw her family and friends, felt the sum of their love, and an intense wave of connectedness washed over her.
“I’m an atheist, but I feel like the way to describe this is bathed in God’s love,” Bazer said. “This love was just — that’s what the universe was, and I was part of it.”
Lisa Callaghan, who lives in Brooklyn, said her husband Patrick Mettes experienced a mystical journey during his psilocybin trial.
Mettes, a TV news director who passed away in 2012, was diagnosed with cancer of the bile d
ucts in 2007. His symptoms were “hellish,” and chemotherapy was quickly wearing him down, his wife remembered.
Callaghan said before taking psilocybin, her husband was a “Type A personality” who struggled with a short temper. Following the treatment, Mettes made peace with his inner turmoil. He was calm and content, and remained so throughout his final months of life.
“He physically felt that he was reborn in this process,” Callaghan said. “The brain is an amazing thing, and the spirit—I think they’re one and the same.”
Griffiths, the Johns Hopkins psychiatrist, said scientists have only a limited understanding of how psychedelics affect the brain’s regions and receptors. Even less is known about how psychedelics might permanently affect people’s personalities.
“We’re really, desperately ignorant,” Griffiths said.
The therapy ‘sweet spot’
MDMA, which isn’t considered a psychedelic, seems to transform patients in a different way.
The compound triggers the release of hormones that inspire feelings of affection and trust, while quieting feelings of fear or threat by slowing activity in the brain’s amygdala.
By contrast, PTSD boosts activity in the amygdala and interferes with brain systems that moderate stress. When PTSD patients attempt to revisit their trauma in therapy, they might be flooded with horrible emotions, or become deeply numbed emotionally.
MDMA helps patients access a “sweet spot” between that overwhelming fear and numbness so they can explore their trauma and find ways to heal, said Michael Mithoefer, a psychiatrist in South Carolina who, with his wife Ann Mithoefer, is studying MDMA-based therapies.
“It’s not just that people get blissed out and everything is fine,” he said. “They’re processing PTSD and there’s a lot of pain.”
“MDMA doesn’t take that away,” he added, “it just makes therapy possible.”
The Mithoefers began studying MDMA in the early 2000s, focusing on people who suffered PTSD as a result of violent crimes, childhood abuse, sexual assault or combat.
They found that 83 percent of participants who received both therapy and MDMA no longer met the clinical criteria for PTSD just two months after their second session with MDMA, according to the 2011 study. Follow-up exams with patients found the improvements lasted more than a year after therapy.
The Mithoefers’ second trial, which included war veterans, firefighters and police officers, has shown similarly positive results. Separate Phase 2 trials have also been held in Switzerland, Israel, Canada and Colorado.
The larger Phase 3 medical trial for MDMA-based therapy could begin sometime next year. If all goes well, the FDA could potentially approve MDMA for prescription use by 2021, said Brad Burge of the Multidisciplinary Association for Psychedelic Studies, a small nonprofit that funded the MDMA trials.
Burge said the organization expects to spend at least $20 million to support the Phase 3 research. Most or all of that money will likely come from private foundations and philanthropists, since no U.S. government institution has backed research on banned substances.
The Heffter Research Institute has raised around $6.7 million in private donations since 1993 to support psilocybin research, with most of the funding spent in the last five years.
“There’s a clear need worldwide for this treatment, and that’s why [research] is accelerating at such a pace right now,” Burge said.
That research also includes gaining a better understanding of people’s experiences on mind-altering drugs. Anthony Bossis, the NYU psilocybin researcher, said he is leading a new FDA-approved trial that asks religious leaders to describe the “landscape” of their mystical journeys while on psilocybin.
For Bazer, whose cancer has now been in remission for six years, the psilocybin treatment has instilled in her a lasting sense of tranquility.
Bazer worked for over 30 years in IT before becoming an ice-skating coach, and she says she was constantly rushing and living under a cloud of stress.
“I’m a typical New Yorker: I walk fast, drive more aggressively than I should, am trying to get ahead all the time,” she said. “Psilocybin kind of slows you down, and I just wanted to hang onto that.”
She hopes more people who are suffering psychologically can participate in clinical trials similar to her own.
“I want to see this research continue,” Bazer said. “I think this really could help people, if they could have this experience I have, and feel this love.”