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Psilocybin Therapy for Cancer

Phase 2
Recruiting
Led By Moran Amit, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an ECOG performance status of 0, 1, or 2
Participants must have one of the specified histology documented tumor types
Must not have
Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG
Actively progressing disease as defined by the primary oncologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.

Summary

This trial aims to investigate whether using psilocybin-assisted therapy can help patients with advanced cancer who are also suffering from depression and/or anxiety. The study will focus on assessing the safety and potential

Who is the study for?
This trial is for patients with advanced cancer who are currently on maintenance therapy and experiencing depression and/or anxiety. Participants should be interested in exploring psilocybin-assisted psychotherapy.
What is being tested?
The study investigates the use of psilocybin, a compound found in magic mushrooms, alongside psychotherapy to see if it can help reduce depression or anxiety in those undergoing treatment for advanced cancer.
What are the potential side effects?
Psilocybin may cause temporary changes in perception, mood swings, dizziness, headaches, nausea or an increase in heart rate. These effects are generally short-lived.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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My cancer type is confirmed by a lab test.
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My cancer has spread, didn't fully respond to treatment but is now stable.
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I haven't had severe side effects from my current cancer treatment.
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I am mentally alert and aware of who I am, where I am, and the current time.
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I am 25 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My health is stable and my blood tests and heart checks are normal.
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My cancer is getting worse according to my cancer doctor.
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I am not a child or cognitively impaired.
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My cancer has spread to my brain.
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I have a serious brain or spinal cord condition.
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My high blood pressure may not allow me to take psilocybin.
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I have other serious health issues, like cancer in my brain or chest, or have had surgery to remove my voice box or tongue.
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I am at risk for a sudden, severe increase in blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and adverse events (AEs)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment2 Interventions
Participants will receive psilocybin (25 mg).
Group II: Arm BPlacebo Group2 Interventions
Participants will receive the placebo (100 mg of Niacin).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,457 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,194 Total Patients Enrolled
Moran Amit, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
18 Total Patients Enrolled
~20 spots leftby Dec 2026
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