Experimental psychedelic therapies returning to VA in at least five trials

The Department of Veterans Affairs recently began offering psychedelic substances to patients as a part of 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 being planned by a handful of government clinicians who see potential in using psychedelic experiences combined with psychotherapy to treat posttraumatic stress disorder, substance abuse and other conditions endemic among veterans of recent wars.

“This is a watershed moment,” 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 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 skilled therapists, can yield powerful insights and disrupt harmful patterns of thought and behavior.

In the 1950s and 1960s, many scientists regarded psychedelics as a potentially revolutionary tool in the treatment of addiction and other psychiatric conditions. In one notable clinical study in 1963, patients at a Veterans Affairs clinic in Kansas took LSD to treat alcoholism.

But that promising wave of research came to a sudden halt soon afterward, as soaring recreational use of hallucinogens sparked 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 combat veterans with post-traumatic stress disorder with MDMA. The trial in New York started in January. Three trials at clinics in San Diego and Portland, Ore., are scheduled to start this year using MDMA and synthetic psilocybin, an analog of hallucinogenic mushrooms.

The research became viable after the FDA designated MDMA and psilocybin as “breakthrough therapies” in 2017 and 2018, for treatment of 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.

In 2020, voters in Oregon passed two ballot measures that decriminalized possession of small amounts of drugs and called for the establishment of a therapeutic framework for psilocybin. Since then, Texas and Connecticut have approved measures allowing the study of psilocybin and MDMA for mental health treatment.

Psychedelic retreats have become booming business in countries in Latin America and Europe where the legal landscape is more permissive. Psychiatry departments at many universities in the United States now have centers where psychedelics are studied. And investors have begun applying for patents, hoping to find novel ways to profit from psychedelic therapy if and when it becomes legal.

Last year, the FDA reviewed 16 applications to treat psychiatric conditions with psychedelic substances, more than in the four previous years combined, according to an agency spokesperson.

In response to an emailed series of questions, the FDA said there are formidable challenges to establishing the safety and efficacy of medicinal psychedelics. For starters, there is no easy way to run studies with a placebo control because the sensory effects of the drugs are evident to participants and researchers. The FDA also cautioned that patients might walk away from psychedelic sessions in a “hypersuggestible” state, which could lead to a merely short-lived sense of improvement.

“Popular media is inundated with overwhelmingly positive references to these drugs, which can potentially influence patients’ and therapists’ expectations,” Dr. Javier Muniz, a senior official at the FDA division that evaluates new drugs, said in a recent online workshop. “The high degree of enthusiasm and anticipation is beyond anything we’ve ever seen with any unapproved psychiatric drug.”

Proponents of accelerating 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.