The Department of Veterans Affairs recently began offering psychedelics to patients for clinical trials, a major step in the quest to determine the therapeutic potential of illegal drugs the federal government has long deemed dangerous.
At least five trials are underway or planned by a handful of government clinicians who see potential in using psychedelic experiences combined with psychotherapy to treat post-traumatic stress disorder, substance abuse and other endemic conditions. among veterans of recent wars.
“This is a watershed moment,” said Dr. Rachel Yehuda, director of mental health at James J. Peters Veterans Affairs Medical Center in the Bronx, who is leading one of the studies. “It’s a time for a lot of hope.”
The theory at the heart of the research is that compounds such as MDMA, also known as ecstasy, and psilocybin mushrooms, when taken in a safe setting under the guidance of trained therapists, can provide information powerful and disrupt harmful patterns of thought and behavior.
In the 1950s and 1960s, many scientists saw psychedelics as a potentially revolutionary tool in the treatment of drug addiction and other psychiatric disorders. In a notable clinical study in 1963, patients at a Kansas veterans clinic took LSD to treat alcoholism.
But this promising wave of research suddenly came to a halt soon after, as the skyrocketing recreational use of hallucinogens sparked a political backlash.
The first of these new psychedelic trials, at a veterans clinic in California, began last summer after researchers received approval from the Drug Enforcement Administration and the Food and Drug Administration to treat veterans suffering from post-traumatic stress disorder with MDMA. The trial in New York began in January. Three trials at clinics in Portland and San Diego are set to begin later this year using MDMA and synthetic psilocybin, a magic mushroom analog.
The research became viable after the FDA designated MDMA and psilocybin as “breakthrough therapies” in 2017 and 2018, for the treatment of PTSD and depression, respectively. Regulators give new drugs this label when preliminary studies suggest they would be more effective than standard treatments for serious conditions.
The studies are taking place amid a global overhaul of the potential dangers and benefits of substances that were banned and demonized during the presidencies of Lyndon B. Johnson and Richard M. Nixon. According to historians, both leaders worried that psychedelic drugs were fueling opposition to the Vietnam War and other government activities.
But in recent years, campaigns to expand research into the medical use of psychedelics and to make related drug laws more lenient have gained support across the country.
In 2020, Oregon voters passed two ballot measures that decriminalize possession of small amounts of the drug and call for a therapeutic framework for psilocybin. Since then, Texas and Connecticut have approved measures allowing the study of psilocybin and MDMA for the treatment of mental health.
Psychedelic retreats have become a booming business in Latin American and European countries where the legal landscape is more permissive. The psychiatry departments of many universities in the United States now have centers where psychedelics are studied. And investors have started applying for patents, hoping to find new ways to profit from psychedelic therapy if and when it becomes legal.
Last year, the FDA reviewed 16 requests for treatment of psychiatric disorders with psychedelics, more than in the previous four years combined, according to an agency spokeswoman.
In response to a series of emailed questions, the FDA said there are enormous challenges in establishing the safety and efficacy of medicinal psychedelics. For starters, there is no easy way to conduct studies with a placebo control because the sensory effects of drugs are obvious to participants and researchers. The FDA also warned that patients could leave psychedelic sessions in a “hyper-suggestible” state, which could lead to a short-lived feeling of improvement.
“The popular media is awash with overwhelmingly positive references to these drugs, which have the potential to influence patient and therapist expectations,” said Dr. Javier Muniz, a senior official in the FDA’s division that evaluates new drugs, during a briefing. a recent online workshop. “The high degree of excitement and anticipation exceeds anything we’ve ever seen with an unapproved psychiatric drug.”
Proponents of ramping up psychedelic research have drawn attention to the mental health care crisis among veterans. In 2019, at least 6,261 veterans died by suicide, according to government data, a rate far higher than that of civilians. Nearly 16% of veterans deployed to Iraq and Afghanistan have been diagnosed with PTSD.
Standard treatments for PTSD at veterans clinics include Prolonged Exposure Therapy, during which patients are asked to repeatedly talk about the source of their trauma, and Cognitive Processing Therapy, which is designed to help them reframe negative thoughts. Many patients are also prescribed anxiolytics and antidepressants.
Hundreds of veterans have traveled to psychedelic retreat centers overseas, and many have become advocates for expanding access to hallucinogens.
“There’s a risk of doing nothing as veterans seek care elsewhere,” said Dr. Shannon T. Remick, a psychiatrist at Veterans Health System in Loma Linda, Calif., who treats patients with PTSD with MDMA. “Our priority is to ensure that veterans are safe and receive the best care.
Dr. Remick’s study includes 10 veterans who will each undergo three sessions of MDMA as well as psychotherapy. Participants will be followed for at least one year.
Overall, the studies will involve a few dozen participants, a tiny segment of the Veterans Affairs patient population. But the researchers said they expect colleagues across the bureaucracy to launch more soon, and larger ones are likely in the future.
In interviews, clinicians conducting psychedelic studies have stated that the veterans’ healthcare system is the ideal place to study the therapeutic potential, limitations, and possible dangers of hallucinogens, which can include cardiovascular abnormalities and episodes of psychosis.
“The VA is in some ways the best place for this kind of research to happen,” said Dr. Leslie Morland, a clinical psychologist at the Veterans Affairs Healthcare System in San Diego, who studies the possibility that MDMA could improve the therapy of couple in marriages strained by PTSD. “The VA is going to make sure we have good data that supports safety and effectiveness before offering it to veterans, as I think is appropriate.”
Dr. Yehuda, a renowned PTSD expert, said she was convinced that psychedelics would become a revolutionary tool in the treatment of mental health. But researchers still have a lot to learn, she says.
“I think it’s going to be a breakthrough for a lot of people,” she said. “But we just have to find out who they are and, more importantly, who they aren’t.”
In his trial, MDMA sessions typically last eight hours, and patients are offered an initial dose and an additional dose. Veterans familiarize themselves with the experience by listening to soft music and are allowed to wear goggles. A pair of therapists watch over the patient, talking to him as little or as much as the patient seems to encourage him.
Dr Yehuda said the sessions can be excruciatingly painful, a process she likened to giving birth.
“The most common misconception about taking MDMA with psychotherapy is that you’re taking this magic pill that will take away your symptoms,” she said. “What happens is you find yourself in a good state to do hard work in a way where you’re in the right window of tolerance where you can engage emotionally, where you can process memory but don’t be so distressed by the memory that you become emotionally numb.
Dr. Yehuda said existing therapies for PTSD often result in reduced distress. But she said early results from MDMA trials showed something surprising in the field.
“A lot of people show what seems like remission,” she said.
The clinicians leading the studies said they were trying to control their enthusiasm as they relied on a body of scientific research.
“We take vulnerable people, especially people with severe mental illness, PTSD, substance abuse disorders, and put them in a vulnerable state of mind, a very impressionable state of mind,” said Dr. Christopher Stauffer, psychiatrist. at the Veterans Affairs Healthcare System in Portland, which runs two psychedelic studies. “We have to be very careful of bias in all directions, from researchers to participants.”
Still, Dr Stauffer said it was imperative to innovate and take thoughtful risks.
“We have a mental health crisis right now and our current mental health system is unable to adequately manage it,” he said.
Some of the VA studies are partly funded and supported by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization that has pressed the federal government to legalize medicinal psychedelics for years. Its executive director, Rick Doblin, said the government could have saved lives by recognizing the therapeutic value of hallucinogens decades ago.
“I’m hopeful the treatment will eventually be widely available across the system,” he said. “Yet I shudder to think of the number of veterans who died of PTSD, often by suicide, during those years.”