Psilocybin Therapy for Cancer

Overseen By Moran Amit, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: Bipolar, Psychosis, Seizures, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether psilocybin, a compound found in certain mushrooms, can reduce depression and anxiety in individuals undergoing treatment for advanced cancer. Participants will receive either psilocybin or a placebo, which is a harmless pill with no active ingredient. The trial targets those with specific types of advanced cancer who are stable on their current treatment but experiencing anxiety or depression due to their diagnosis. Participants must be prepared to travel to the trial location and refrain from drug use during the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Participants must stop taking certain medications, including antidepressants, centrally-acting serotonergic agents, antipsychotics, mood stabilizers, and significant inhibitors of specific enzymes, at least two weeks before the study. However, prescribed opiates and benzodiazepines can continue if stable for a specified period before screening.

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

Research has shown that psilocybin therapy is generally safe for people with cancer. Studies have found that it can be used safely in the right environment. For instance, one study discovered that psilocybin helped reduce depression in cancer patients without causing serious side effects. Another study indicated that combining psilocybin with therapy may safely help relieve chronic pain in cancer patients who need opioids.

Most people did not experience dangerous side effects, as serious adverse events were not commonly reported. However, some individuals might temporarily feel changes in mood or perception during treatment. These effects are usually mild and resolve on their own.

Overall, psilocybin shows promise as a safe treatment option for people with advanced cancer who are dealing with depression or anxiety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer, which often include chemotherapy, radiation, and surgery, psilocybin therapy offers a unique approach by using a psychedelic compound derived from certain mushrooms. Researchers are excited about psilocybin because it works on the brain's serotonin receptors, potentially helping to alleviate anxiety and depression in cancer patients, which are common side effects of traditional treatments. Additionally, psilocybin may provide long-lasting psychological benefits after just one or two sessions, which is faster and more sustainable than conventional therapies that can take weeks or require ongoing treatment.

What evidence suggests that psilocybin might be an effective treatment for depression and/or anxiety in cancer patients?

Research has shown that psilocybin, which participants in this trial may receive in Arm A, may help reduce depression and anxiety in cancer patients. In one study with 51 cancer patients, psilocybin significantly reduced these symptoms. Another study found that a single dose of psilocybin led to complete relief from depression in 50% of participants, with 80% showing improvement. These results suggest that psilocybin could effectively treat depression and anxiety in people with cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Moran Amit, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My cancer has spread, didn't fully respond to treatment but is now stable.

I can avoid taking psychoactive drugs around my psilocybin sessions.

I haven't taken any psychiatric drugs for a set period before this study.

Exclusion Criteria

My cancer is getting worse according to my cancer doctor.

My cancer has spread to my brain.

I have a serious brain or spinal cord condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psilocybin-assisted psychotherapy or placebo for depression and/or anxiety

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm A Experimental Treatment 2 Interventions

Participants will receive psilocybin (25 mg).

Group II: Arm B Placebo Group 2 Interventions

Participants will receive the placebo (100 mg of Niacin).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Gateway for Cancer Research

Collaborator

Trials

47

Recruited

2,500+

Published Research Related to This Trial

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

A meta-analysis of psilocybin studies found that higher doses of psilocybin are associated with stronger subjective experiences, particularly in areas like perceptual alterations and ego dissolution, based on data from standardized questionnaires.

Challenging experiences were less affected by dose, suggesting that individual and environmental factors also play a significant role in the psilocybin experience, indicating that these findings are most relevant in controlled settings rather than recreational use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response relationships of psilocybin-induced subjective experiences in humans. Hirschfeld, T., Schmidt, TT.[2022]

A new liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed to quickly and accurately measure the levels of psilocybin and psilocin in magic truffles, with high precision and reliability (r² > 0.99).

The study found that only psilocybin was present in the examined Psilocybe sclerotia, with concentrations ranging from 59.3 to 167.8 µg per 100 mg of fresh truffles, indicating variability in psilocybin content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magic truffles or Philosopher's stones: a legal way to sell psilocybin? Pellegrini, M., Rotolo, MC., Marchei, E., et al.[2019]

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.

The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. Curry, SC., Rose, MC.[2019]

In a study examining the effects of Psilocybe cubensis and Panaeolus cyanescens mushrooms on heart cells, the extracts did not worsen hypertrophy caused by endothelin-1 and provided protection against TNF-α-induced cell injury.

The findings suggest that these mushroom extracts can be safely used in controlled conditions for potential therapeutic benefits in heart disease, although caution is advised with higher concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. Nkadimeng, SM., Steinmann, CML., Eloff, JN.[2021]

In a study involving 12 healthy adults, escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) were administered safely, with no serious adverse events reported, indicating a favorable safety profile for this psychedelic compound.

The pharmacokinetics of psilocin, the active metabolite of psilocybin, were linear across the tested doses, with an elimination half-life of about 3 hours, suggesting that no dose adjustments are necessary for individuals with mild to moderate renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Brown, RT., Nicholas, CR., Cozzi, NV., et al.[2022]

The review highlights that five major mushrooms—Agaricus blazei, Cordyceps sinensis, Grifola frondosa, Ganoderma lucidum, and Trametes versicolor—can modify cytokine levels in cancer models, potentially influencing the disease process and immune response.

In addition to their immunological roles, these mushrooms may enhance the efficacy of chemotherapy and mitigate myelosuppression, with promising preliminary research suggesting their potential as adjunct treatments in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Modulation From Five Major Mushrooms: Application to Integrative Oncology. Guggenheim, AG., Wright, KM., Zwickey, HL.[2020]

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

Psilocybin shows promising effects in alleviating anxiety, depression, and emotional distress in palliative care patients, with a favorable safety profile, based on recent studies and reports.

Despite its potential benefits, psilocybin is not yet approved for therapeutic use in the U.S., and significant barriers exist for access, particularly for vulnerable populations like the elderly and those in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update. Whinkin, E., Opalka, M., Watters, C., et al.[2023]

A long-term follow-up of 15 participants from a previous trial showed that psilocybin-assisted psychotherapy led to sustained reductions in anxiety, depression, and other distressing symptoms, with 60-80% of participants still experiencing significant improvements 3.2 to 4.5 years later.

Participants reported that the psilocybin therapy was among the most meaningful experiences of their lives, indicating its potential to enhance psychological and spiritual well-being in patients facing life-threatening cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. Agin-Liebes, GI., Malone, T., Yalch, MM., et al.[2023]

Medicinal mushrooms like Shiitake, Turkey Tail, and Scaly Wood show promise in cancer treatment by potentially preventing lymph node metastasis, prolonging survival, and reducing side effects from chemotherapy, based on a review of nine studies.

The review highlights the need for more rigorous research, including randomized controlled trials with larger sample sizes, to confirm these benefits and determine the most effective dosages for patients with high-mortality cancers such as gastric, breast, and colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Medicinal Mushrooms on Gastric, Breast, and Colorectal Cancer: A Scoping Review. Dan, A., Swain, R., Belonce, S., et al.[2023]

Citations

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

Assessment of Psilocybin Therapy for Patients With Cancer ... Nonetheless, this study demonstrates the safety and preliminary efficacy of psilocybin treatment for patients with cancer and depression using ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07216404?aggFilters=status%3A

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 ...

4. compasspathways.com compasspathways.com/our-work/comp360-psilocybin-treatment-in-trd/

COMP360 psilocybin treatment in TRD This trial assessed the safety and efficacy of COMP360 psilocybin treatment in three doses: 1mg, 10mg, 25mg. The results, published in the New England Journal ...

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Psilocybin eases depression in patients with cancer, study ... A week after treatment with a single dose of psilocybin, 50% of participants had experienced a full remission of depressive symptoms and 80% had ...

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Single-Dose Psilocybin for a Treatment-Resistant Episode ... Its potential antidepressant efficacy was suggested by preliminary studies involving patients with life-threatening cancer.

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Assessment of Psilocybin Therapy for Patients With Cancer ... Outcome measures included safety and improvement in depression, which was primarily measured with the Montgomery-Asberg Depression Rating ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06827054

Psilocybin With Psychotherapy for Improving Chronic Pain ... Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05506982?term=psychedelic&cond=cancer&viewType=Table&rank=7

Study Details | NCT05506982 | Psilocybin Combined With ... This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with ...