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Psilocybin-Assisted Therapy for Depression in Lung Cancer

This study is testing psilocybin (a psychedelic compound) combined with therapy for people with non-small cell lung cancer (NSCLC) who also have major depressive disorder. A cancer diagnosis can cause significant emotional distress, and this study aims to see if psilocybin-assisted therapy is safe and acceptable. Researchers will also look at how well it reduces depression and improves quality of life. You may be able to join if you have NSCLC, a good performance status (meaning you can perform most daily activities), and are at least 18 years old. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is testing the safety and acceptability of psilocybin-assisted therapy.
What's involved
You would participate in two preparation therapy sessions, receive psilocybin orally during a single dosing therapy session, and attend two post-dosing therapy sessions. You will also provide blood and urine samples throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After completing the study treatment, participants will be followed up at 4 and 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07216404

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
Alan Davis
~10 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCounselingInterviewPsilocybinSurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ratings of suicidal ideation on the Columbia- Suicide Severity rating scale (C-SSRS)
Measured over At baseline, one day post-drug session, and 4 weeks post-drug session
+3 more outcomes measured

Conditions

Lung Non-Small Cell Carcinoma
Unipolar Depression

Explore related trials

Lung Non-Small Cell CarcinomaUnipolar Depression

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Alan K Davis, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

Ohio State University Comprehensive Cancer Center
[email protected]
18002935066
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals diagnosed with NSCLC, confirmed by pathology report
Have a Karnofsky performance status \>= 60

Exclusion

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)
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
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)

What this trial measures

  • Ratings of suicidal ideation on the Columbia- Suicide Severity rating scale (C-SSRS)At baseline, one day post-drug session, and 4 weeks post-drug session

    Ratings of suicidal ideation on the C-SSRS will be summarized with means and standard deviations (SD) at baseline, one day post-drug session, and 4 weeks post-drug session. A mixed effects regression model will be fit containing a fixed effect for visit to test for a significant change in ratings of suicidal ideation from baseline to 4 weeks post drug session. Estimated mean differences will be presented with corresponding 95% confidence intervals (CI). An alpha level of 0.05 will be used to determine statistical significance.

  • Incidence of adverse eventsAt baseline, one day post-drug session, and 4 weeks post-drug session

    Descriptive analysis of adverse event reporting logs will be conducted to determine if any serious adverse events have been reported related to psilocybin administration.

  • Acceptability of psilocybin-assisted therapyAt end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session

    The mean (SD) change in Participant/Client Satisfaction Questionnaire levels between end of preparatory session 2 (visit 3; 7 days prior to drug administration) and 4 weeks post-drug session will be presented and a paired t-test will be used to test for a significant increase/decrease in acceptability. The estimated mean change will be presented with corresponding 95% confidence interval (CI). An alpha level of 0.05 will be used to determine statistical significance.

  • Satisfaction of psilocybin-assisted therapyAt end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session

    The mean (SD) change in Participant/Client Satisfaction Questionnaire levels between end of preparatory session 2 (visit 3; 7 days prior to drug administration) and 4 weeks post-drug session will be presented and a paired t-test will be used to test for a significant increase/decrease in satisfaction. The estimated mean change will be presented with corresponding 95% confidence interval (CI). An alpha level of 0.05 will be used to determine statistical significance.