Psilocybin-assisted Psychotherapy for Cancer Survivors

Overseen By Moran Amit, MD, PHD

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

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: Unknown

Duration: 2 doses

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if psilocybin-assisted therapy can safely and effectively aid cancer survivors struggling with depression or anxiety. Participants will receive psilocybin, a compound found in certain mushrooms, along with therapy to assess its impact on mental health. Suitable candidates have had cancer without brain involvement, are currently disease-free, but experience depression or anxiety related to their cancer journey. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. Participants must be free from regularly scheduled psychotropic medications for at least 2 weeks before the study, or 4 weeks for SSRIs. Some prescribed medications, like opiates and benzodiazepines, can continue if stable for a certain period before screening.

Is there any evidence suggesting that psilocybin-assisted psychotherapy is likely to be safe for cancer survivors?

Studies have shown that psilocybin is generally safe in a controlled setting. Research with cancer patients suggests it can help reduce anxiety and depression. Some individuals may experience temporary side effects during treatment, but these are usually mild and short-lived. Overall, psilocybin is well-tolerated in a supportive environment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer survivors, which often include antidepressants or therapy, psilocybin-assisted psychotherapy uses psilocybin, a compound found in certain mushrooms, to potentially alleviate psychological distress. Researchers are excited about psilocybin because it targets the brain's serotonin receptors in a unique way, potentially leading to profound changes in mood and perception. This new approach may offer faster and more lasting relief from anxiety and depression compared to traditional methods, offering hope for a transformative impact on mental health in cancer survivors.

What evidence suggests that psilocybin-assisted psychotherapy might be an effective treatment for depression and anxiety in cancer survivors?

Research has shown that psilocybin can greatly reduce depression and anxiety in cancer patients. In one study, 83.3% of patients felt better after 8 weeks, and 50% experienced complete relief from depression. Another study found that just one dose of psilocybin led to full relief from depression in half of the participants just one week after treatment, with 80% reporting reduced depression. This trial will investigate psilocybin-assisted psychotherapy as a promising treatment for depression and anxiety in cancer survivors. ^{1 5 6 7 8}

Who Is on the Research Team?

Moran Amit, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult cancer survivors who are now free of disease but suffer from depression and/or anxiety. They must not have brain involvement, be fluent in English, able to travel for sessions, and agree to avoid certain substances. Excluded are those with a high suicide risk, recent severe depression before cancer diagnosis, pregnant women or without contraception use, vulnerable populations like children or cognitively impaired individuals.

Inclusion Criteria

I will stop taking certain enzyme inhibitors before taking psilocybin.

My cancer does not affect my brain.

Agree to abstain from nicotine products for specified periods

Exclusion Criteria

My close family has a history of specific mental health conditions.

My current cancer treatment is aimed at easing symptoms.

Clinically significant suicidality or high risk of completed suicide

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 for depression and/or anxiety

2 doses

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The TRIPS study tests psilocybin-assisted psychotherapy's safety and effectiveness on cancer survivors with depression/anxiety. Participants will undergo therapy sessions where they'll receive psilocybin—a substance found in magic mushrooms—to see if it helps improve their mental health conditions.

How Is the Trial Designed?

Group I: Treatment with Psilocybin Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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]

In a double-blind, placebo-controlled trial with 29 cancer patients, a single dose of psilocybin (0.3 mg/kg) combined with psychotherapy led to significant and lasting reductions in anxiety and depression, with 60-80% of participants showing sustained improvements at a 6.5-month follow-up.

The positive effects of psilocybin were linked to the mystical experiences it induced, which helped improve patients' quality of life, reduce existential distress, and foster better attitudes towards death.

NCBI (Pubmed)

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. Ross, S., Bossis, A., Guss, J., et al.[2022]

The HOPE trial, involving 12 cancer patients, showed that psilocybin-assisted group therapy is safe, with no serious adverse events reported, and resulted in significant reductions in depression symptoms over six months.

Participants experienced substantial decreases in depression scores, with six out of twelve achieving remission at two weeks, indicating that this group therapy model could be an effective treatment for depression in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. Lewis, BR., Garland, EL., Byrne, K., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11271737/

Investigating the therapeutic efficacy of psilocybin in advanced ... Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial.

2. 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.

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

Assessment of Psilocybin Therapy for Patients With Cancer ... About 15% of patients with cancer experience major depression, which is associated with lower treatment adherence and reduced quality of ...

4. 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 ...

5. dana-farber.org dana-farber.org/newsroom/news-releases/2023/psilocybin-eases-depression-in-patients-with-cancer-study-finds

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 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S277240852400125X

Safety pharmacology of acute psilocybin administration in ... The results of this study indicate that psilocybin appears to be safe in a controlled setting with transient adverse effects. The safety data can partially be ...

7. 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 ...

8. hopkinsmedicine.org hopkinsmedicine.org/psychiatry/research/psychedelics-research

Psychedelics Research and Psilocybin Therapy In a small double-blind study, Johns Hopkins researchers report that a substantial majority of people suffering cancer-related anxiety or depression found ...