Carolyn Clancy, MD, VA Assistant Under Secretary for Health
WASHINGTON, DC — After decades of being considered fringe science by lawmakers, research into psychedelics for the treatment of post-traumatic stress disorder (PTSD) is finding bipartisan support in Congress.
In July, Democrats and Republicans worked together to include language encouraging VA to conduct more research into methylenedioxy-methylamphetamine (MDMA) and similar drugs into the House’s version of the federal budget bill. Last month, the House VA Subcommittee on Health Oversight questioned VA leaders about these drugs’ potential applications in combating veteran suicide.
“Psychedelic-assisted therapy is a groundbreaking procedure that has the potential to transform the way we look at mental healthcare,” declared Rep. Mariannette Miller-Meeks (R-IA). “Based on the most recent clinical trials, patients experience positive therapeutic responses, resulting in a reduction of their symptoms if not remission altogether. We can’t be afraid to explore new treatment methods [that] have been proven to change veterans’ lives.”
In September, VA hosted a state-of-the-art (SOTA) conference into psychedelic treatment for mental health conditions. With the conference, the department had goals in mind: Get a better understanding of the current state of scientific evidence and identify steps to allow widespread clinical implementation following FDA approval.
“VA is conducting several studies on psychedelics,” said VA Assistant Under Secretary for Health Carolyn Clancy, MD, who testified for the department at the hearing.
Those studies, she said, include two phase-3 trials of MDMA treatment for PTSD, which have shown significant reduction of symptoms.
However, she noted, all of these projects are currently funded by outside organizations. While there are no statutory barriers for VA to fund the research themselves, VA scientists have been deterred by the amount of red tape involved.
“This is a highly regulated environment,” Clancy explained. “It requires that investigators invest a considerable amount of time in getting approval from the FDA and DEA down to the precise doses used in the treatment. We have done nothing to discourage this. But the timeframe in getting these approvals has been something of a disincentive.”
The interest in employing MDMA as an additional treatment for PTSD is widespread among VA clinicians and not new, Clancy said. “Work in this field began in the early 1960s; then there was a hiatus. I imagine the Controlled Substances Act had something to do with that. It’s not that there was suddenly a campaign. This has been growing for the past few years.”
The recent conference proved that clinician enthusiasm has not waned, she added. “For the people in our system who invest a fair amount of time in providing care to people with PTSD—they were inspired and very hopeful and hoping more science [will] get us to a place where we can know if this is a breakthrough for veterans and which veterans and how do we do that safely.”
Should the FDA approve MDMA for the treatment of PTSD, the biggest hurdle will likely not be getting clinicians to accept the treatment, but rather making sure they are trained in how to administer it. In the trials, not only is the drug administered on-site, but veterans are observed and guided as they experience its effects.
“All the VA providers who participated in these trials have gone through intensive therapy,” Clancy said. “Others have sought it from the organization MAPs (Multidisciplinary Association for Psychiatric Studies) on their own because they see it as part of the future and a skill set that they will very much need.”
The fact that the MDMA studies have required drug administration on-site, with the effects monitored in person, quelled some lawmakers’ worries that veterans could divert the drug for recreational use.
“[Veterans] are not using the psychedelics to alter their state in the sense of getting high or avoiding. They’re using this medication in the context of facilitating an insight, of allowing them to connect with traumatic material, to build empathy, to build compassion and to confront things that they just haven’t been able to confront before,” explained Rachel Yehuda, PhD, director of the Center for Psychedelic Psychotherapy and Trauma Research, a joint project between the Bronx VA and Mount Sinai Hospital. “The idea is not to let myself feel good from a drug; it’s to put myself into a state that is most conducive to safely exploring material that is very difficult. It’s a very different paradigm than the paradigm of drug-seeking behavior that lets you forget.”
Committee member, Rep. Morgan Luttrell (R-TX), also spoke to the unpleasant but very effective nature of the treatment. Luttrell served as a Navy SEAL for 14 years before being medically retired for severe traumatic brain and spinal cord injury. Suffering from PTSD, Luttrell traveled to Mexico to receive psychedelic therapy, which he said had profoundly beneficial results.
“I have gone through these treatments,” he declared. “It was challenging but life changing. There are no rules and regulations preventing VA from moving forward with this. Our veterans are ready.”
