20 Participants Needed

Psilocybin-assisted Psychotherapy for Cancer Survivors

MA
Overseen ByMoran Amit, MD, PHD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

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.

How is the drug psilocybin unique in treating anxiety and depression in cancer survivors?

Psilocybin is unique because it is used in combination with psychotherapy to provide rapid and long-lasting relief from anxiety and depression in cancer survivors, enhancing spiritual well-being and quality of life. Unlike traditional treatments, it involves a single high-dose session that can lead to significant improvements in mood and outlook, with effects lasting for months.12345

What data supports the effectiveness of the drug psilocybin for cancer survivors?

Research shows that psilocybin, when used with therapy, can significantly reduce depression and anxiety in cancer patients, improving their quality of life and sense of well-being. In studies, many patients experienced lasting improvements in mood and outlook on life after treatment.12356

Who Is on the Research Team?

MA

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
See 9 more

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
See 16 more

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?
1Treatment groups
Experimental Treatment
Group I: Treatment with PsilocybinExperimental Treatment1 Intervention

Find a Clinic Near You

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

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.
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.
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]
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.
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]

Citations

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. [2023]
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. [2018]
Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. [2023]
Individual Experiences in Four Cancer Patients Following Psilocybin-Assisted Psychotherapy. [2020]
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. [2022]
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