RecruitingPhase 2NCT07216404

Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer

Exploring the Safety, Acceptability, and Efficacy of Psilocybin Among Non-Small Cell Lung Cancer Patients With Major Depressive Disorder: A Proof-of-Concept Trial (DREAM LUNG STUDY)

Sponsor

Alan Davis

Enrollment

10 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Lung Non-Small Cell Carcinoma Unipolar Depression

Summary

This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing psilocybin-assisted therapy (a structured therapeutic session using a carefully dosed psychedelic compound) for people with non-small cell lung cancer (NSCLC) who are also experiencing moderate to severe depression. **You may be eligible if...** - You have confirmed non-small cell lung cancer - You are experiencing moderate to severe depression - You are 18 or older and can read English - You are considered low risk for suicidality - You have had limited prior use of hallucinogens (no use in the past 5 years preferred; fewer than 10 lifetime uses) - You are reasonably functional (Karnofsky performance status 60 or above) **You may NOT be eligible if...** - You have a personal or close family history of schizophrenia, psychosis, or bipolar I or II disorder - You have had a serious suicide attempt - You have moderate to severe alcohol or drug use disorder in the past year - You have uncontrolled high blood pressure, recent heart attack, stroke, or significant heart problems - You have insulin-dependent diabetes or a seizure disorder - You are pregnant or breastfeeding - You are enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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