The phase 2 DREAM LUNG study, currently underway at The Ohio State University, is examining the effects of psilocybin-assisted therapy on major depressive disorder in patients with non-small cell lung cancer. The study, co-led by Theodore Wagener, PhD, founding director of the Center for Tobacco Research at Ohio State, aims to enroll 10 patients as a proof-of-concept trial (NCT07216404).
Read More
The primary endpoints of the study focus on safety, adverse events, suicidal ideation, and patient satisfaction with the therapy, while secondary endpoints include assessing depression symptom severity and quality of life. Eligible participants must exhibit moderate to severe depressive symptoms and can continue existing chemotherapy, radiation, or biologic therapies while undergoing treatment with psilocybin, a Schedule I substance.
In a recent interview, Wagener discussed the rationale behind the study, highlighting the high rate of psychological distress among lung cancer patients, with approximately 40% meeting criteria for depression and a significant incidence of suicide. He noted the potential of psychedelics to address existential distress, as traditional treatments may not fully resonate with the unique challenges faced by this patient population.
The study employs a single-arm design, providing preparation and integration therapy alongside the psilocybin dosing session. Though still in its early stages, three patients have completed treatment, showing promising signs of efficacy consistent with findings from other studies involving psilocybin and depression.
Wagener expressed hope that psilocybin could yield rapid and transformative changes in mood and perception of life’s meaning—particularly vital for lung cancer patients who often face advanced diagnoses and urgent existential questions. He noted the previous work suggesting psychedelics could also enhance cognitive function and alleviate chemotherapy-induced neuropathy, linking it to increased neuroplasticity and potential neurogenesis.
As research in this area progresses, Wagener emphasized the importance for oncologists to understand that the use of psilocybin is controlled and intentional, differing significantly from recreational use. He urged medical professionals to consider the emerging data, highlighting significant findings published in reputable medical journals.
The DREAM LUNG study's potential implications underscore a shift in cancer treatment paradigms, suggesting a growing intersection between oncology and psychedelic research. Further results from this ongoing trial could inform the future of therapeutic interventions for patients grappling with the psychological burdens of cancer.