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Lung Non-Small Cell CarcinomaPhase 2NCT07216404

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

A Phase 2 study testing Biospecimen Collection, Counseling and Interview in people with Lung Non-Small Cell Carcinoma and Unipolar Depression, run by Alan Davis at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Counseling and Interview
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Jan 2026to 31 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ohio State University Comprehensive Cancer Center contact

18002935066

osucccclincaltrials@osumc.edu

Michelle Pham, M.S. contact

pham.303@osu.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Michelle Pham, M.S., pham.303@osu.edu

    Alan K. Davis, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety and acceptability of psilocybin-assisted psychotherapy with non-small cell lung cancer (NSCLC) patients.

SECONDARY OBJECTIVE:

  1. To determine the efficacy of psilocybin-assisted therapy in the reduction of depression and the impact of treatment on quality of life, cancer-related stress, and existential distress.

OUTLINE:

Patients participate in two preparation therapy sessions over 4 hours each on days 7 and 14, then patients receive psilocybin orally (PO) on day 21 and participate in a single dosing therapy session for over 8-10 hours on study. Patients also complete two post-dosing therapy sessions over 2 hours each on days 22 and 28 on study. Patients additionally undergo blood and urine sample collection throughout the study.

After completion of study treatment, patients are followed up at 4 and 12 weeks.

Being tested
Biospecimen Collection, Counseling, Interview, Psilocybin, Survey Administration
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and urine sample collection

  • CounselingOther

    Also called Counseling Intervention

    Participate in therapy sessions

  • InterviewOther

    Ancillary studies

  • PsilocybinDrug

    Also called [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate

    Given PO

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07216404
Study groupRoleWhat they receive
Supportive Care (counseling sessions, psilocybin)ExperimentalPatients participate in two preparation therapy sessions over 4 hours each on days 7 and 14, then patients receive psilocybin PO on day 21 and participate in a single dosing therapy session for over 8-10 hours on study. Patients also complete two post-dosing therapy sessions over 2 hours each on days 22 and 28 on study. Patients additionally undergo blood and urine sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Other: Counseling; Other: Interview; Drug: Psilocybin; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ratings of suicidal ideation on the Columbia- Suicide Severity rating scale (C-SSRS)

    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.

    Measured: At baseline, one day post-drug session, and 4 weeks post-drug session

  2. Incidence of adverse events

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

    Measured: At baseline, one day post-drug session, and 4 weeks post-drug session

  3. Acceptability of psilocybin-assisted therapy

    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.

    Measured: At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session

  4. Satisfaction of psilocybin-assisted therapy

    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.

    Measured: At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session

Secondary outcomes (6)

  1. Depression symptom severity

    Mean (SD) ratings of depression symptom severity will be presented from baseline, end of preparatory session 2 (visit 3; 7 days prior to drug administration), 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 depressive symptom severity 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.

    Measured: At baseline, end of visit 3 (7 days prior to drug administration), and 4 weeks post-drug session.

  2. Quality of life (Medical Outcomes Study-Short Form-12)

    The Medical Outcomes Study-Short Form-12 (SF-12) is a 12-item self-report measure assessing health- related quality of life during the past month.184 The SF-12 assesses eight aspects of quality of life including physical functioning, role functioning physical, general health perceptions, vitality, social functioning, role functioning emotion, and mental health. Scores from the eight are weighted and summed for two scores: physical component summary (PCS) and mental component summary (MCS) score. Mean (SD) ratings for each of the quality of life measures will be presented.

    Measured: AT baseline, preparatory session 2, and 4 weeks post-drug session

  3. Quality of Life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13)

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) is a common, validated measure assessing the frequency of common symptoms of lung cancer and lung cancer treatments.The EORTC QLQ-LC 13 contains nine items that assess individual symptoms (e.g., pain, coughing) and one three-item symptom scale that assesses dyspnea. Patients rated the extent to which each symptom was experienced in the past week on a 4-point Likert scale (1=not at all to 4=very much). Each item is transformed to a score ranging 0-100, with lower scores indicating better health-related quality of life and lower symptoms. Mean (SD) ratings for each of the quality of life measures will be presented.

    Measured: At baseline, preparatory session 2, and 4 weeks post-drug session

  4. Quality of Life (Impact of Events Scale-Revised)

    The Impact of Events Scale-Revised is a 22-item expansion of the original 15-item IES which assesses subjective distress caused by any specific life event.The items and 3 subscales (Intrusion, Avoidance, and Hyperarousal) correspond closely with the symptoms associated with a DSM-IV diagnosis of PTSD. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") to yield a total score (ranging from 0 to 88). Mean (SD) ratings for each of the quality of life measures will be presented.

    Measured: At baseline, preparatory session 2, and 4 weeks post-drug session

  5. Quality of Life (Demoralization Scale)

    The Demoralization Scale (DEM) is a 24-item self-report questionnaire which was developed to measure demoralization in patients with advanced cancer. It covers 5 dimensions of demoralization: loss of meaning and purpose (five items), dysphoria (five items), disheartenment (six items), helplessness (four items), and sense of failure (four items). Items are rated on five-point Likert scales ranging from 0 (never) to 4 (all the time). A total score is obtained by summing up the single scale scores. Mean (SD) ratings for each of the quality of life measures will be presented.

    Measured: At baseline, preparatory session 2, and 4 weeks post-drug session

  6. Quality of Life (NIH Healing Experience of All Life Stressors)

    The NIH Healing Experience of All Life Stressors (NIH-HEALS)is a 35-item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative Care Service as a psycho-social-spiritual measure of healing that assesses positive transformation in response to challenging life events.The scale has a three-factor structure (Connection, Reflection \& Introspection, and Trust \& Acceptance), and items are rated on a 5-point scale (1, "strongly disagree" to 5 "strongly agree"). Mean (SD) ratings for each of the quality of life measures will be presented.

    Measured: At baseline, preparatory session 2, and 4 weeks post-drug session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2025
  2. Study start1 Jan 2026
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07216404
Sponsor's protocol ID
OSU-24170
Other IDs
NCI-2025-06353
Status last verified
May 2026
First submitted
29 Sep 2025
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Counseling and Interview in people with Lung Non-Small Cell Carcinoma and Unipolar Depression, run by Alan Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ohio State University Comprehensive Cancer Center (18002935066, osucccclincaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratings of suicidal ideation on the Columbia- Suicide Severity rating scale (C-SSRS) (time frame: At baseline, one day post-drug session, and 4 weeks post-drug session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07216404.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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