Psilocybin for Psychological Distress in Pancreatic and Biliary Tract Cancer

Overseen by Lou Lukas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Nebraska

Must not be taking: MAOIs, Lithium, Antipsychotics, others

Disqualifiers: Schizophrenia, Bipolar, Seizures, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a psilocybin-based treatment to help patients with inoperable pancreas or biliary tract cancers feel less distressed. Psilocybin, found in certain mushrooms, can change brain activity to improve mood and reduce anxiety. The study will also look at how this treatment affects patients' families. Psilocybin has been historically used for ritualistic, recreational, and medicinal purposes, with recent studies recognizing its potential to treat depression and anxiety.

Will I have to stop taking my current medications?

The trial requires stopping certain medications, especially psychotropic drugs like MAOIs, lithium, or anti-psychotics, and potent metabolic inducers or inhibitors. If you're on these medications, you may need to stop them to participate.

What data supports the effectiveness of the drug psilocybin for psychological distress in cancer patients?

Research suggests that psilocybin may help reduce symptoms of depression and anxiety in cancer patients, with effects lasting for at least six months after a single treatment. Studies have shown promising results in treating depression and existential distress in people with serious medical illnesses, including cancer. ^{1 2 3 4 5}

Is psilocybin safe for use in humans?

Research indicates that psilocybin is generally safe for use in humans, with studies showing promise in treating depression and anxiety in patients with life-threatening diseases. Clinical trials have reported its safety in healthy adults and cancer patients, with no major safety concerns noted. ^{1 5 6 7 8}

How is psilocybin different from other drugs for psychological distress in pancreatic and biliary tract cancer?

Psilocybin is unique because it is a psychedelic substance that can help improve mood and reduce anxiety and depression in cancer patients, offering rapid and lasting relief. Unlike traditional treatments, it is used in a single dose combined with psychotherapy, and its effects can last for months, enhancing quality of life and spiritual well-being. ^{4 5 9 10 11}

Research Team

Lou Lukas, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for adults aged 19-85 with inoperable pancreatic or biliary tract cancer experiencing distress. They must speak English, have a life expectancy of at least 8 weeks, and be able to consent to the study. A family member must also participate. Exclusions include severe depression/anxiety, substance abuse, certain medical conditions like CNS metastases or major organ dysfunction, and those on specific medications.

Inclusion Criteria

Participant must have a life expectancy ≥ 8 weeks as determined by referring oncologist

I am under 55, had a menstrual cycle in the last 2 years, and agree to use birth control during the study.

I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

You have a problem with alcohol or using drugs for fun, except for caffeine and nicotine.

I have heart or blood circulation problems.

I am not pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Sessions

Preparatory sessions in outpatient palliative care clinic or by telehealth (2-4 sessions lasting 60-90 minutes each)

2-4 weeks

2-4 visits (in-person or virtual)

Psilocybin Treatment

Participants receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling

1 day

1 visit (in-person)

Integration Sessions

Integration sessions (2-3 sessions lasting up to 90 minutes each) in outpatient palliative care clinic or by phone or tele-health

1-2 weeks

2-3 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with exploratory measures collected up to 12 months post baseline

12 months

Multiple visits (in-person or virtual)

Treatment Details

Interventions

• Psilocybin (Psychedelic)

Trial Overview The trial tests psilocybin's effect on psychological distress in patients with inoperable pancreatobiliary cancer. It aims to recruit participants and their family members (observational arm) to measure changes in distress levels before and after treatment over time.

Participant Groups

Group I: Psilocybin Treatment Arm Experimental Treatment 1 Intervention

Participant with pancreatobilliary cancer will receive 25mg of psilocybin in one 8-hour monitored session with supportive counseling before and after session.

Group II: Family Observation Group Active Control 1 Intervention

The study participant will select a family member who will provide parallel data regarding distress related to pancreatobiliary cancer.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Michael Dixon

University of Nebraska

Chief Executive Officer since 2010

PhD in Molecular Biology

Dr. Makker

University of Nebraska

Chief Medical Officer since 2020

MD from University of Nebraska Medical School

Lou Lukas

Lead Sponsor

Trials

1

Recruited

20+

Nebraska University Foundation

Collaborator

Trials

1

Recruited

20+

Jim Young Pancreatic Cancer Research Memorial Fund

Collaborator

Trials

1

Recruited

20+

Findings from Research

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

Psilocybin has shown promise in reducing symptoms of depression and anxiety, particularly in cancer patients, with effects lasting for at least six months after a single treatment, based on three controlled studies.

In small pilot studies, psilocybin has also demonstrated potential effectiveness in treating addiction to alcohol and cigarettes, suggesting its versatility as a therapeutic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Effects of Psilocybin: A Systematic Review. Goel, DB., Zilate, S.[2022]

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]

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]

Psilocybin has shown significant therapeutic effects in reducing symptoms of depression and anxiety in patients with life-threatening diseases, based on a systematic review and meta-analysis of clinical trials involving 92 patients.

The results indicate that psilocybin may be a safe and effective treatment option, particularly for cases resistant to conventional therapies, with significant improvements measured by the Beck Depression Inventory and State-Trait Anxiety Inventory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. Vargas, AS., Luís, Â., Barroso, M., et al.[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]

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]

In a phase 2 trial with patients suffering from major depressive disorder, psilocybin therapy (PT) led to significant improvements in personality traits associated with mental health, such as decreased neuroticism and increased openness, after 6 weeks.

Both psilocybin and escitalopram treatments resulted in positive changes in personality, but no significant differences were found between the two treatments, suggesting that both may be effective in improving mental health through similar mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personality change in a trial of psilocybin therapy v. escitalopram treatment for depression. Weiss, B., Ginige, I., Shannon, L., 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Effects of Psilocybin: A Systematic Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Personality change in a trial of psilocybin therapy v. escitalopram treatment for depression. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. [2022]