NCT06818994

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Gustavo Vazquez · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, suicidal ideation, and quality of life. Unfortunately, so far no pharmacological strategy has been devised for demoralization, and only a few psychotherapeutic approaches have been trialed in this population, though no psychotherapeutic treatments have been tested for demoralization specifically. The new wave of psychedelic research has been showing encouraging results in a broad spectrum of psychiatric diagnosis, including depression and anxiety in patients diagnosed with cancer and other life-threatening diseases. To date, no clinical trials have been published in which the potential therapeutic effects of psychedelics are explored for the treatment of demoralization syndrome. The aim of this open label pilot study is to assess the safety and efficacy of psilocybin-assisted psychotherapy as a treatment for demoralization syndrome in patients diagnosed with cancer. Fifteen participants between the ages of 18 to 70 years with advanced stage cancer and demoralization syndrome will be enrolled in a treatment program which will include 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session. Our outcome of interest will be a decrease in demoralization, as measured by the Demoralization Scale at baseline and at the end of the study, and adverse events registration. Other measures of interest include Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and the Columbia Suicide Severity Rating Scale. Those patients with partial response a month after the psilocybin intervention will be offered the possibility of a second psilocybin 25 mg dosing session.

Conditions

• Demoralization
• Safety

Interventions

Type	Name	Description
DRUG	Psilocybin-assisted Psychotherapy	The intervention will be psilocybin-assisted psychotherapy. The first treatment period will include four preparation sessions with Managing Cancer and Living Meaningfully (CALM) therapy elements. The psilocybin dosing session will take place after these preparation sessions are completed. The dosing session will include an in-person visit lasting approximately 8 hours in which the participant will receive a capsule of psilocybin 25 mg under constant supervision of therapists. The following day, the first integration session will take place and two weeks later the second integration session along with CALM will be conducted. Participants who show a partial response will be offered a second dosing session, entering the second treatment period. The second treatment period includes a second dosing session using the same dose and safety measures as the first one. It will also be followed by an integration session the following day, and a second integration session with CALM two weeks later.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-02-11
• Last updated: 2026-03-18

Locations

1 site across 1 country: Canada