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Experimental Psychedelic Therapy Returns to the V.A.

The Department of Veterans Affairs recently began offering psychedelic substances to patients as part of clinical trials, an important step in the search for the therapeutic potential of illegal drugs that the federal government has long considered dangerous.

At least five studies are underway or planned by a handful of government clinicians that see potential in using psychedelic experiences in conjunction with psychotherapy to treat post-traumatic stress disorder, substance abuse, and other conditions endemic among veterans of recent wars. .

“This is a turning point,” said Dr. Rachel Yehuda, director of mental health at the James J. Peters Veterans Affairs Medical Center in the Bronx, who is leading one of the studies. “This is a time for much hope.”

The theory underlying the research is that compounds such as MDMA, also known as ecstasy, and psilocybin mushrooms, when taken in a safe environment under the guidance of experienced therapists, can provide powerful insights and prevent harmful thinking and disrupt behavioral patterns.

In the 1950s and 1960s, many scientists considered psychedelics to be a potentially revolutionary tool in the treatment of addiction and other psychiatric conditions. In a remarkable clinical study in 1963, patients at a Veterans Affairs clinic in Kansas were taking LSD to treat alcoholism.

But that promising wave of research came to a sudden halt soon after, when surging recreational use of hallucinogens caused a political backlash.

The first of these new psychedelic trials, at a Veterans Affairs clinic in California, began last summer after researchers received approval from the Drug Enforcement Administration and the Food and Drug Administration to treat veterans with post-traumatic stress disorder with MDMA. The trial in New York began in January. Three trials at clinics in Portland and San Diego are scheduled to begin later this year on MDMA and synthetic psilocybin, an analog of hallucinogenic mushrooms.

The study became viable after the FDA designated MDMA and psilocybin as “breakthrough therapies” in 2017 and 2018, for treatment from PTSD and depression, respectively. Regulators give that label to new drugs when preliminary studies suggest they would be more effective than standard treatments for serious conditions.

The investigations come amid a global rethink of the dangers and potential benefits of substances banned and demonized during the presidencies of Lyndon B. Johnson and Richard M. Nixon. According to historians, both leaders became concerned that psychedelic drugs were fueling opposition to the Vietnam War and other government activities.

But in recent years, campaigns to expand research into the medicinal uses of psychedelics and ease associated drug laws have gained support across the country.

In 2020, Oregon voters passed two ballot measures that: decriminalized property of small amounts of drugs and called for the establishment of a therapeutic framework for psilocybin. From that moment on, Texas and Connecticuthave approved measures that allow the study of psilocybin and MDMA for the treatment of mental health.

Psychedelic Retreats have become booming business in countries in Latin America and Europe where the legal landscape is more tolerant. Psychiatry departments at many universities in the United States now have centers studying psychedelics. And investors have started filing for patents, hoping to find new ways to take advantage of psychedelic therapy if and when it becomes legal.

Last year, the FDA reviewed 16 applications for the treatment of psychiatric conditions with psychedelics, more than in the previous four years combined, an agency spokeswoman said.

In response to a series of e-mailed questions, the FDA said there are enormous challenges in determining the safety and efficacy of medicinal psychedelics. For starters, there is no easy way to conduct studies with a placebo control, as the sensory effects of the drugs are obvious to participants and researchers. The FDA has also warned that patients may walk away from psychedelic sessions in a “hyper-suggestible” state, which could lead to only a short-lived sense of improvement.

“Popular media is flooded with overwhelmingly positive references to these drugs, which can potentially influence the expectations of patients and therapists,” said Dr. Javier Muniz, a senior officer in the FDA’s department evaluating new drugs, in a recently online workshop. “The high level of enthusiasm and anticipation is beyond anything we’ve ever seen with unapproved psychiatric drugs.”

Proponents of accelerating psychedelic research have drawn attention to the mental health crisis among veterans. In 2019 at least 6,261 veterans died by suicide, according to government data, a much higher percentage than that of citizens. Almost 16 percent of veterans those deployed to Iraq and Afghanistan have been diagnosed with PTSD.

The standard treatments for PTSD at Veterans Affairs, clinics include long-term exposure therapy, in which patients are urged to talk repeatedly about the source of their trauma, and cognitive processing therapy, which is designed to help them reframe negative thoughts. Many patients are also prescribed anti-anxiety drugs and antidepressants.

Hundreds of veterans have traveled to psychedelic retreat centers abroad, and many have become advocates for expanding access to hallucinogens.

“There’s a risk that you won’t do anything because veterans are seeking care elsewhere,” says Dr. Shannon T. Remick, a psychiatrist at the Veterans Affairs Healthcare System in Loma Linda, California, who treats PTSD patients with MDMA. “It is our priority to ensure that veterans are safe and receive the best care.”

Research by Dr. Remick includes 10 combat veterans who will each undergo three MDMA sessions along with psychotherapy. Participants are followed for at least one year.

Overall, the studies will involve several dozen participants, a small fraction of the Veterans Affairs patient population. But the researchers said they expect colleagues across the bureaucracy to launch more soon, with bigger ones likely in the future.

In interviews, the clinicians leading psychedelic studies said the Veterans Affairs health care system is the ideal place to study the therapeutic potential, limitations and potential dangers of hallucinogens, including cardiovascular anomalies and episodes of psychosis.

“The VA is in some ways the best place for this kind of research,” says Dr. Leslie Morland, a clinical psychologist at the Veterans Affairs Healthcare System in San Diego, who is studying the possibility that MDMA may improve couples therapy in marriages strained by PTSD. “The VA is going to make sure we have good data to support its safety and efficacy before offering it to veterans, as I think is appropriate.”

dr. Yehuda, a renowned expert on PTSD, said she was convinced that psychedelics would become a revolutionary tool in mental health treatment. But researchers still have a lot to learn, she said.

“I think it will 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 her trial, MDMA sessions typically last eight hours and patients are offered an initial and supplemental dose. Veterans enjoy the experience by listening to soft music and are allowed to wear eyeshadow. A few therapists monitor the patient and speak as little or as much as the patient seems to encourage.

dr. Yehuda said sessions can be excruciatingly painful, a process she likened to giving birth.

“The most common misconception about MDMA in psychotherapy is that you take this magic pill that will take your symptoms away,” she said. “What happens is you get into a state that’s conducive to doing hard work in a way where you’re in the right window of tolerance where you can engage emotionally, where you can process the memory but not like it so much.” upset by the memory of becoming emotionally numb.”

dr. Yehuda said existing therapies for PTSD often led to a reduction in anxiety. But she said the early results of MDMA studies showed something amazing in the field.

“A lot of people show what looks like remission,” she said.

The clinicians leading the studies said they were trying to control their enthusiasm while building on a body of scientific research.

“We take vulnerable people, especially people with severe mental illness, PTSD, substance abuse disorders, and we put them in a vulnerable state of mind, a very impressionable state of mind,” said Dr. Christopher Stauffer, a psychiatrist. at the Veterans Affairs Healthcare System in Portland, which leads two psychedelic studies. “We have to be super careful about bias in all directions, from the researchers to the participants.”

Yet said Dr. Stauffer that it was absolutely necessary to innovate and take deliberate risks.

“We have a mental health crisis right now and our current mental health system is not able to manage it adequately,” he said.

Some of the VA studies are funded and supported in part by the Multidisciplinary Association for Psychedelic Studies, a nonprofit that has been pushing the federal government for years to legalize medicinal psychedelics. Its executive director, Rick Doblin, said the government could have saved lives decades ago by recognizing the therapeutic value of hallucinogens.

“I’m hopeful that the treatment will eventually be widely available throughout the system,” he said. “Yet I shudder to think of how many vets died of PTSD in those years, often by suicide.”

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