RecruitingPHASE1INTERVENTIONAL

Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer

This study is investigating a new type of therapy called psilocybin-assisted psychotherapy for people with advanced cancer who are experiencing something called 'demoralization syndrome'. This is when someone feels a deep sense of hopelessness or loss of purpose. The study aims to find out if this treatment is safe and if it can help improve how these patients feel. Psilocybin is a naturally occurring compound found in certain mushrooms. Participants will have therapy sessions and one dose of psilocybin, with the possibility of a second dose if needed. Researchers will be checking if patients feel less demoralised and if there are any side effects.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Gustavo Vazquez

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Jun 2027

Demoralization Safety

What is this study about?

This study is testing a new way to help people with advanced cancer who are feeling very low or losing hope, a condition doctors call 'demoralization syndrome'. It's common for up to a third of cancer patients to go through this. When someone is demoralised, it can also lead to other problems like feeling sad, anxious, or even having thoughts about suicide, and it can greatly affect their quality of life. Currently, there aren't many specific treatments for demoralisation, especially not medicines.

Recently, there's been growing interest in using psychedelic substances, like psilocybin, in a controlled medical setting to help with various mental health conditions. Some studies have shown promising results for depression and anxiety, including in cancer patients. However, no one has specifically looked at whether psilocybin-assisted therapy can help with demoralisation syndrome.

This study hopes to change that. It's a small, initial study involving 15 patients. The main goal is to see if psilocybin-assisted psychotherapy is safe for these patients and if it helps them feel less demoralised. Participants will attend several therapy sessions and have one session where they receive a small dose of psilocybin, along with support. If they haven't improved enough after a month, they might be offered a second dose. Researchers will closely monitor how patients feel and whether they experience any side effects.

Key takeaways

This study explores psilocybin-assisted therapy for cancer patients feeling demoralised.
It aims to check if the treatment is safe and effective for this specific problem.
Participants will have therapy sessions and one or two doses of psilocybin in a controlled setting.
Researchers will monitor emotional well-being and any side effects.
Participation requires meeting specific health criteria, including age and cancer stage.
It's a pilot study, meaning it's an early investigation into this potential treatment.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old and have been diagnosed with advanced-stage cancer (stage 3 or 4). You'll also need to be experiencing a moderate to severe level of demoralisation, as measured by a specific questionnaire.

There are also some important reasons why you might not be able to take part. For example, if you have a primary brain tumour, or certain mental health conditions like schizophrenia or bipolar disorder (either yourself or a close family member). If you have certain medical conditions like epilepsy or a history of stroke, or if you're taking medications that could interact badly with psilocybin, you also wouldn't be able to join.

The study also requires you to be able to understand and sign a consent form, and if you can get pregnant or get someone pregnant, you’ll need to use reliable contraception throughout the study and for 4 months afterward.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have advanced-stage cancer (stage 3 or 4)?
Are you feeling quite demoralised or hopeless, as if you've lost purpose?
Do you speak English well enough to understand study information?
Do you NOT have a primary brain tumour?
Do you NOT have a history of schizophrenia or bipolar disorder (yourself or a close family member)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure it's safe and appropriate for you. If you fit the criteria, you would then have a total of 6 psychotherapy sessions and one main session where you receive a 25mg dose of psilocybin, along with supportive care. During and after the psilocybin session, the medical team will be with you to provide support and ensure your safety.

After the psilocybin session, doctors will check how you are feeling. If you haven't responded much after a month, you might be offered a second 25mg dose of psilocybin. Throughout the study, your emotional well-being, mood, and any side effects will be regularly monitored using questionnaires. The total length of your participation in the study, including all sessions and follow-ups, would be several months.

Potential risks and benefits

Participating in this study might offer a potential benefit of reducing feelings of demoralisation, anxiety, and depression, improving your overall emotional well-being. However, there are potential risks, as psilocybin can cause temporary changes in perception, mood, and thinking, and some people may experience anxiety or discomfort during the session. The research team will be there to support you throughout. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Queen's University
Verified postcode
Kingston, Canada· Recruiting

Common questions

What is 'demoralization syndrome'?

It's a deep feeling of hopelessness, sadness, and loss of purpose, often experienced by people with serious illnesses like advanced cancer.

What is psilocybin?

Psilocybin is a natural substance found in certain mushrooms. In this study, it's used in a carefully controlled medical setting alongside therapy.

Will I be alone during the psilocybin session?

No, you will be with medical professionals and therapists who are trained to support you throughout the session.

What if I feel worse after the treatment?

The medical team will closely monitor you for any side effects or worsening of symptoms and will provide support. You can withdraw from the study at any time.

Is this treatment available to everyone with cancer?

No, this is a research study with specific criteria for who can participate. It's not a standard treatment currently available outside of clinical trials.

How to find out more

Gustavo Vazquez, MD, PhD, FRCPC

vazquezg@providencecare.ca 613-544-4900 x51214 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.