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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Urine samples
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients additionally undergo blood and urine sample collection throughout the study."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and side effects of psilocybin given with therapy for major depression. It is for adults with non-small cell lung cancer and moderate to severe depression. Psilocybin is a substance from mushrooms that can make people sense things that are not real.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be older than 18 and have non-small cell lung cancer confirmed by a lab report.
- Have a score of at least 60 on a scale measuring how well you can do daily activities.
- Have moderate to severe depression, with a score above 16 on the study’s depression test.
- Speak English and be able to read.
- Give written consent to join the study.
- Be judged by the study team to have a low risk of suicide.
- Have limited past use of drugs that cause people to sense things that are not real. Preferably, no use in the past 5 years and fewer than 10 uses total.
- You may receive chemotherapy, radiation, or biologic cancer treatments if you tolerate them well enough to take psilocybin by mouth and meet the other study rules.
Who can't join
- Be pregnant or breastfeeding, or be sexually active without the required birth control when you or your partner could become pregnant.
- Have certain heart or blood vessel problems, such as recent heart disease or stroke, uncontrolled chest pain, certain abnormal heart tests, an artificial heart valve, or a mini-stroke in the past year. Average blood pressure above 139/89 or heart rate above 90 also rules you out.
- Have diabetes that needs insulin, or diabetes without insulin use but with recent low blood sugar that caused symptoms.
- Have serious brain or nerve problems, such as an unstable brain tumor, unstable seizures, an unstable bulging blood vessel in the brain, dementia, or severe confusion.
- Have exam or test results, or a current illness, that the study doctor believes would make participation unsafe or prevent following study steps. This includes trouble swallowing medicine. Receiving an experimental treatment in another trial also rules you out.
- Regularly use certain medicines or drugs that affect the mind, based on the clinician’s judgment. Daily SSRI or SNRI antidepressants and bupropion below 300 mg daily are exceptions. Other drug use may also rule you out; do not stop prescribed medicines for this study.
- Have a personal or close family history of bipolar disorder or certain disorders that affect a person’s sense of reality. A moderate or severe alcohol or drug use disorder now or within the past year also rules you out, except for caffeine or tobacco.
- Have a mental health condition that prevents building trust with the therapist, or a past suicide attempt judged medically serious by the study team.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Individuals diagnosed with NSCLC, confirmed by pathology report * Have a Karnofsky performance status \>= 60 * Participants receiving chemotherapy, radiation therapy, and biologic therapies may participate while receiving those therapies if they are tolerating the therapy or treatment sufficiently to allow administration of oral psilocybin and if treatments do not result in meeting any of the medical exclusion criteria outlined below * Moderate to severe symptoms of depression (GRID Hamilton Rating Scale for Depression \[GRID-HAMD\] \> 16) * English-speaking * Over the age of 18 * Have given written informed consent * Able to read * Be judged by study team clinicians to be at low risk for suicidality, as defined by a score of =\< 2 on the Columbia- Suicide Severity rating scale (C-SSRS) ideation subscale, 0 on the behavior subscale, and by overall clinical judgment; and * Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times) Exclusion Criteria: * GENERAL MEDICAL EXCLUSION CRITERIA * Participants who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; participants who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control (i.e., implants, injectables, combined oral contraceptives, progestin containing intrauterine devices \[IUDs\], or vasectomized partner) * Participants with partners of child-bearing potential who are sexually active and not practicing a highly effective means of contraception (i.e., condom with spermicidal foam/gel/film/cream/suppository) * Cardiovascular conditions: Recent history of coronary artery disease or stroke, current uncontrolled angina, uncontrolled hypertension, a clinically significant electrocardiogram (ECG) abnormality as determined by a cardiologist and/or medical monitor (e.g., atrial fibrillation), prolonged corrected QT (QTc) interval (i.e., QTc \> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year * Systolic blood pressure (SBP) \> 139 mm HG; diastolic blood pressure (DBP) \> 89 mm HG; heart rate (HR) \> 90 bpm (mean values of the four or more assessments will not exceed 139 mm Hg systolic, 89 mm Hg diastolic, and/or 90 beats per minute) * Insulin-dependent diabetes * Non-insulin dependent diabetes if recent history of symptomatic hypoglycemia * Significant central nervous system (CNS) pathology. Some examples include: * Unstable primary or secondary (e.g., metastatic) cerebral neoplasm. Stable is defined as treatment within prior 4 weeks or no immediate plans for treatment. * Unstable history of seizures * Cerebral aneurysm - unstable with plans for intervention or close monitoring * Clinical diagnosis of dementia * Clinical diagnosis of delirium * In the investigator's opinion, abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at screening may constitute a risk for an individual exposed to psilocybin. This includes platelets below 100,000 platelets per cubic millimeter of blood, liver function tests three times the upper limit of normal, and creatine two times above the normal range. This also includes clinically significant abnormal electrolytes or low hemoglobin (below 10 g/L) * Any acute condition that would, in the Investigator's judgment, place the subject at significant risk due to safety concerns or compliance with clinical study procedures (e.g., electrolyte imbalance, infection/inflammation, intestinal obstruction, inability to swallow medication, etc.) * Under active treatment of an investigational agent in a clinical trial * In the judgement of the clinician, patients currently taking psychoactive medication on a regular (e.g., daily) basis (e.g., cannabis, opiates, Ritalin), other than a daily selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), or bupropion (\< 300 mg daily) (Patients will not be instructed to hold prescribed psychoactive medications) * In the judgement of the clinician, patients who self-report or urine test positive for psychoactive medications (e.g., illicit opiates, amphetamines, cocaine) may be excluded, for example recent use by self-report but urine test negative may still be enrolled, while participants with impaired mental status will be excluded * PSYCHIATRIC EXCLUSION CRITERIA * Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I or II disorder * Current or history within one year of meeting DSM-5 criteria for a moderate or severe alcohol or other drug use disorder (excluding caffeine and tobacco) * Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition) or bipolar I or II disorder * Has a psychiatric condition that precludes the establishment of therapeutic rapport, as evidenced by long-term patterns of unstable relationships, a history of significant stress-related paranoia, and identity disturbances * History of a medically significant suicide attempt as determined by the study team and principal investigator (PI)
Study sites (1)
OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Michelle Pham, M.S. · Study contact · pham.303@osu.eduAlan K. Davis, PhD · Principal investigatorMore trials in Columbus