Psilocybin-Assisted Therapy for Depression in Lung Cancer

Overseen By Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alan Davis

Must not be taking: Psychoactive medications

Disqualifiers: Pregnancy, Cardiovascular conditions, Diabetes, CNS pathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if psilocybin, combined with therapy, can safely and effectively treat depression in patients with non-small cell lung cancer. Depression often affects lung cancer patients, worsening their quality of life. Participants will receive psilocybin, a compound from mushrooms, in a controlled setting with supportive care. This trial may suit English-speaking individuals diagnosed with non-small cell lung cancer who experience moderate to severe depression. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain psychoactive medications, but you can continue taking daily SSRIs, SNRIs, or bupropion under 300 mg. The trial does not specify a washout period, but the decision will be made by the clinician based on your current medications.

Is there any evidence suggesting that psilocybin-assisted therapy is likely to be safe for humans?

Research has shown that using psilocybin with therapy might be safe for treating depression in cancer patients. Studies indicate that cancer patients, even those with major depression, generally tolerate psilocybin therapy well. Some patients experienced side effects, but these were usually mild and temporary.

One study found that psilocybin-assisted therapy was safe and feasible for cancer patients with depression. This research suggests the treatment could help improve mood and reduce anxiety. While psilocybin can cause hallucinations (seeing or hearing things that aren't real), supportive care during therapy sessions often manages these effects well.

Overall, existing evidence suggests that psilocybin therapy might be a safe option for those with depression related to cancer, but experiences can vary for each person. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for depression in lung cancer patients, such as antidepressants and psychotherapy, can take weeks or even months to show significant effects. But psilocybin-assisted therapy works differently, targeting the brain's serotonin receptors, which can lead to rapid changes in mood and perception. Researchers are excited about psilocybin because it may offer fast-acting relief and potentially shift long-held negative thought patterns in just a few sessions. This approach combines the active ingredient psilocybin with intensive therapy, aiming to provide a deeper, more transformative experience compared to traditional treatments.

What evidence suggests that psilocybin-assisted therapy could be an effective treatment for depression in lung cancer?

Research has shown that psilocybin, when combined with therapy, can help reduce depression and anxiety in cancer patients. One study found that 83.3% of cancer patients responded positively to psilocybin treatment after eight weeks, with half experiencing complete remission of depression. Another study discovered that a single dose of psilocybin led to a 53% reduction in self-reported depression levels. In this trial, participants will receive psilocybin as part of supportive care, which includes counseling sessions. These findings suggest that psilocybin might effectively treat major depression, particularly in patients with non-small cell lung cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Alan K Davis, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with non-small cell lung cancer who are also experiencing major depressive disorder. Participants should be willing to undergo therapy sessions and take psilocybin, a substance derived from mushrooms that can cause hallucinations.

Inclusion Criteria

English-speaking

I have moderate to severe depression symptoms.

Have given written informed consent

Exclusion Criteria

Participants with partners of child-bearing potential who are sexually active and not practicing a highly effective means of contraception

Any acute condition that would place the subject at significant risk due to safety concerns or compliance with clinical study procedures

Under active treatment of an investigational agent in a clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation Therapy

Participants undergo two preparation therapy sessions over 4 hours each on days 7 and 14

2 weeks

2 visits (in-person)

Psilocybin Dosing

Participants receive psilocybin orally and participate in a single dosing therapy session for over 8-10 hours on day 21

1 day

1 visit (in-person)

Post-Dosing Therapy

Participants complete two post-dosing therapy sessions over 2 hours each on days 22 and 28

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study is testing the safety and effectiveness of psilocybin when combined with therapy to treat depression in lung cancer patients. It involves biospecimen collection, interviews, counseling, and surveys to assess outcomes.

How Is the Trial Designed?

Group I: Supportive Care (counseling sessions, psilocybin) Experimental Treatment 5 Interventions

Patients 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.

Who Is Running the Clinical Trial?

Alan Davis

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5367557/

Psilocybin produces substantial and sustained decreases ... Previous studies suggest that psilocybin may decrease depression and anxiety in cancer patients. The effects of psilocybin were studied in 51 cancer patients ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07216404?term=NA

Psilocybin-Assisted Therapy for the Treatment of Major ... Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.12021

Long term efficacy of psilocybin in patients with cancer and ... Response to psilocybin treatment was observed in 83.3% of patients at 8 weeks, and 50% of patients showed full remission of depressive symptoms.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2803623

Assessment of Psilocybin Therapy for Patients With Cancer ... The Maudsley Visual Analogue Scale showed a change of −46.2 (95% CI, −61.6 to −30.7) points, a 53% decrease in self-rated depression severity. ...

5. ascopost.com ascopost.com/news/june-2025/psilocybin-may-benefit-patients-with-cancer-major-depressive-disorder/

Psilocybin May Benefit Patients With Cancer, Major ... A single dose of psilocybin may provide sustained reductions in depression and anxiety among patients with cancer and major depressive disorder.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.12097

The safety and efficacy of psilocybin therapy in patients ... This trial built upon previous studies and tested the safety, feasibility, and efficacy of psilocybin therapy in cancer patients diagnosed with major ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206443

Single-Dose Psilocybin for a Treatment-Resistant Episode ... A total of 6% of the participants had previous exposure to psilocybin. Lifetime depressive episodes — no. Plus–minus values are means ±SD.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11083170/

Review of Psilocybin Use for Depression among Cancer ... Psilocybin therapy shows promise for reducing anxiety and depression and improving psychological well-being in cancer patients nearing the end of life.

9. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35010

Psilocybin‐assisted group therapy in patients with cancer ... Psilocybin-assisted therapy in group cohort administration was safe and feasible in patients with cancer and depression. Efficacy was suggested ...