In a separate study at the Center for Psychedelic Medicine at the New York University (NYU) School of Medicine, researchers are conducting a clinical trial using psilocybin-assisted therapy to treat existential distress in patients with advanced-stage cancer in collaboration with colleagues at the University of Colorado. Dr. Xiaojue Hu, a psychiatrist and researcher at NYU’s Center for Psychedelic Medicine, noted that the study “is building on the same work in this area originally done at NYU in the 2010s.

”  “Now, there are many other studies using psilocybin in cancer patients, including a study using psilocybin in combination with multidisciplinary palliative care to treat demoralized cancer survivors with chronic pain going on at Emory University,” she told SurvivorNet. Hu explained that psychedelic-assisted therapy could be a more sustainable and effective treatment for cancer patients than other commonly prescribed alternatives including antidepressants.  “From the psilocybin research on depression alone, we’ve seen clinically significant impact from just one or two doses of psilocybin in conjunction with therapeutic support that can last up to 14 months for some patients,” said Hu.

“This is in contrast to antidepressants, which people have to take on a daily basis for potentially years, with a risk of relapse when the meds are tapered off.” Clinical research and other studies into psychedelics such as psilocybin and MDMA have shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, PTSD, substance misuse disorders and anxiety. In January, a California biopharmaceutical company announced positive results from a clinical trial testing MDMA as a treatment for PTSD.

Research published in the peer-reviewed journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. A separate study published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. Although the research is promising, Hu said that psychedelic-assisted therapy does not work for everyone and that further research is needed to confirm the efficacy and safety of the treatment.

“Psychedelics aren’t a panacea or miracle cure for anxiety and depression, as there’s still much that’s unknown about them and there’s always the potential for adverse effects, like with any treatment,” Dr. Hu said. Hu added that research has focused on using psychedelic treatments in conjunction with multiple sessions that integrate more traditional forms of therapy. “Most of the research is also done when psychedelics, such as psilocybin, are used in the context of therapeutic support with usually two therapists, which can include up to three sessions of preparation and three sessions of integration afterwards,” she said.

“So the results are not completely due to the physiologic effects of psilocybin alone, in my opinion, but must be taken into context with the therapeutic and environmental support that’s also offered.” Hu also noted that psychedelic-assisted therapy is conducted in a tightly controlled environment because the set and setting in which a patient receives the treatment can have an impact on its success. “We typically don’t expect different results if someone took their Lexapro [an antidepressant] in different moods, with different people, or in different environments, but we definitely can when it involves psychedelics,” she said.

While the research continues, the use of psychedelics to treat serious mental health conditions such as anxiety and depression has yet to achieve approval from health regulators. The U.S. Department of Health and Human Services projects that the Food and Drug Administration will eventually approve MDMA and psilocybin mental health treatments, according to a letter from the department in May 2022. In 2017, the FDA granted MDMA-assisted therapy Breakthrough Therapy designation, indicating that the therapy is a significant improvement over existing treatments.

  The Multidisciplinary Association for Psychedelic Studies (MAPS) predicts that an application to use MDMA to treat PTSD will be submitted to the FDA at some point in 2023, and approval could come as early as 2024. But so far, MDMA-assisted therapy has not been approved by any regulatory agency and the safety and efficacy of MDMA-assisted therapy for the treatment of PTSD have not been firmly established. “MDMA and psilocybin have the most clinical research and legal momentum behind them right now, with psilocybin already being legalized in Oregon and Colorado and MDMA phase III trials recently being completed,” said Hu. Read less