Psilocybin Therapy for Anxiety and Depression in Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how psilocybin therapy can reduce anxiety and depression in cancer patients. It targets those with metastatic solid tumors or incurable blood cancers. The treatment combines psilocybin, which may alter brain activity and mood, with group therapy sessions. Individuals experiencing anxiety or depression related to their cancer and willing to participate in group therapy may be suitable for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Do I need to stop taking my current medications for the trial?
You may need to stop taking certain medications, especially psychiatric medications, during the study. If you are on selective serotonin reuptake inhibitors (SSRIs) or other psychiatric medications, you should discuss this with the study team. Some medications, like MAOIs and tramadol, are not allowed, and you must avoid starting new psychiatric medications during the trial.
Is there any evidence suggesting that psilocybin therapy is likely to be safe for humans?
Research has shown that psilocybin therapy might be safe for treating anxiety and depression in cancer patients. In earlier studies, cancer patients who received psilocybin reported lower levels of depression and anxiety. For instance, one study found a 53% drop in depression severity based on patients' own ratings after receiving the treatment. These studies also suggest that patients generally tolerated psilocybin therapy well, with no serious side effects reported. Although researchers continue to study psilocybin, early results appear promising for its safety and effectiveness in helping cancer patients with anxiety and depression.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for anxiety and depression in cancer patients, which often involve antidepressants and therapy, psilocybin therapy is derived from a psychedelic compound found in certain mushrooms. Psilocybin works by affecting serotonin receptors in the brain, potentially leading to profound shifts in mood and perception. Researchers are excited because this treatment could offer rapid and long-lasting relief, sometimes noticeable after just one session, which is significantly faster than traditional antidepressants. Additionally, the integration of group and individual therapy sessions enhances the therapeutic experience, helping patients process and integrate their experiences effectively.
What evidence suggests that psilocybin therapy might be an effective treatment for anxiety and depression in cancer patients?
Research has shown that psilocybin can help reduce anxiety and depression in cancer patients. In studies with these patients, psilocybin significantly lowered these symptoms. One study found that about 80% of patients felt better, with some experiencing complete relief from their depression. In this trial, participants will receive psilocybin therapy, which changes brain activity and helps improve mood. This treatment is used alongside therapy sessions to help patients better understand their situation. Early results suggest that this method is both safe and effective.12467
Who Is on the Research Team?
Anthony Back, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for patients with metastatic solid tumors or incurable blood cancers who are experiencing anxiety and depression. Participants must be adults capable of giving consent and able to engage in therapy sessions. Those with certain psychiatric disorders, heart conditions, or on medications that interact poorly with psilocybin cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Participants attend group and individual preparation therapy sessions
Treatment
Participants receive psilocybin therapy, with potential for a booster dose
Integration
Participants attend group and individual integration therapy sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The study examines the safety and effectiveness of group retreat psilocybin therapy combined with psychotherapy for reducing anxiety and depression in cancer patients. It involves taking a pharmaceutical-grade psilocybin approved for research, followed by structured discussions.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients attend group preparation therapy sessions on days -14 (virtual), -7 (virtual) and -1 (in person), and also attend an individual preparation therapy session on day -1 (in person). Patients receive psilocybin orally (PO) on day 0. Patients may receive an additional "booster" dose 60-90 minutes after the initial dose based on the physician's clinical judgement. Patients attend group integration therapy sessions on days 1 (in person), 8 (virtual), 15 (virtual), and 22 (virtual), and attend individual integration therapy sessions on days 1 (in person) and 8 (virtual).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Healing Hearts, Changing Minds, Inc.
Collaborator
Psilo Scientific Ltd
Collaborator
Citations
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 ...
Psychedelics Research and Psilocybin Therapy
2022 (Milestone) : Psilocybin Treatment for Major Depression May be Effective for Up to a Year. Previous studies by Johns Hopkins Medicine researchers showed ...
Assessment of Psilocybin Therapy for Patients With Cancer ...
Psilocybin is a 5-HT2A receptor agonist with success in reducing a variety of psychiatric symptoms while using 2 therapists per patient. To ...
Efficacy of psilocybin for treating symptoms of depression
In our meta-analysis we found that psilocybin use showed a significant benefit on change in depression scores compared with placebo. This is ...
5.
cancertherapyadvisor.com
cancertherapyadvisor.com/features/psilocybin-psychotherapy-depression-cancer/Psilocybin and Psychotherapy Can Improve Depression in ...
Overall, 80% of patients had a sustained response to psilocybin. Half of patients had a full remission of depressive symptoms (defined as a ...
Funded Grants | Division of Cancer Prevention
Based on extensive preliminary data, psilocybin-assisted therapy has demonstrated both safety and preliminary efficacy to improve cancer-related depression and ...
NCT06801041 | TRIPS - Treatment to Improve Depression ...
To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for cancer survivor patients with depression and/or anxiety.
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