Psilocybin-assisted Psychotherapy for Demoralization

Overseen By Gustavo Vazquez, MD, PhD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Gustavo Vazquez

Must not be taking: MAO inhibitors, Antipsychotics, Mood stabilizers, others

Disqualifiers: Primary brain tumor, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with psilocybin, such as MAO inhibitors, antipsychotics, mood stabilizers, aldehyde dehydrogenase inhibitors, and significant inhibitors of UGT 1A0 or UGT 1A10. If you are on these medications and cannot taper off, you may not be eligible to participate.

What data supports the effectiveness of the treatment Psilocybin-assisted Psychotherapy for demoralization?

Research shows that psilocybin-assisted psychotherapy has been effective in improving demoralization in patients with cancer and has shown promise in treating depression, anxiety, and other mental health conditions. Studies indicate that even a few doses can lead to long-term positive effects, making it a promising alternative for those who do not respond to traditional treatments. ^{1 2 3 4 5}

Is psilocybin-assisted therapy safe for humans?

Psilocybin-assisted therapy is generally well tolerated in humans, with most side effects being mild and temporary. Serious adverse events are rare, but there have been reports of increased suicidal thoughts and behaviors in some individuals, indicating the need for careful supervision and further research. ^{1 2 4 6 7}

How is psilocybin-assisted psychotherapy different from other treatments for demoralization?

Psilocybin-assisted psychotherapy is unique because it uses psilocybin, a psychedelic compound, in controlled doses under medical supervision to potentially provide rapid and long-lasting improvements in demoralization, even after just one or a few sessions. This approach is different from traditional treatments as it targets the brain's neural networks, potentially disrupting dysfunctional patterns associated with psychiatric disorders. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-70 with advanced stage cancer who are experiencing demoralization syndrome. Participants will undergo psychotherapy sessions and a psilocybin dosing session. Those showing partial response may receive a second dose.

Inclusion Criteria

English proficiency

Individuals of child-bearing potential who are sexually active must agree to use an acceptable contraceptive method throughout their participation in the study

Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30

Exclusion Criteria

I have been diagnosed with delirium.

Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder

Significant suicide risk as defined by suicidal ideation with intent and a plan

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session

6 weeks

6 psychotherapeutic visits, 1 psilocybin dosing session

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments using the Demoralization Scale, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and Columbia Suicide Severity Rating Scale

10-13 weeks

Optional Second Dosing

Participants with partial response a month after the psilocybin intervention may receive a second psilocybin 25 mg dosing session

Treatment Details

Interventions

• Psilocybin-assisted Psychotherapy

Trial Overview The study tests the safety and effectiveness of psilocybin-assisted psychotherapy in reducing feelings of hopelessness (demoralization) in cancer patients. It includes several therapy sessions, one or possibly two doses of psilocybin, and various mental health assessments.

Participant Groups

Group I: advanced cancer participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Gustavo Vazquez

Lead Sponsor

Trials

2

Recruited

100+

Gustavo Vazquez

Lead Sponsor

Trials

2

Recruited

100+

Findings from Research

In a study involving 18 older long-term AIDS survivor men, psilocybin-assisted group therapy was found to be feasible and relatively safe, with no serious adverse reactions reported and only mild expected side effects experienced by some participants.

Participants showed a significant reduction in demoralization levels from baseline to a 3-month follow-up, indicating potential efficacy for psilocybin therapy in addressing psychological distress in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. Anderson, BT., Danforth, A., Daroff, PR., et al.[2023]

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Psilocybin-Assisted Treatment of Depression, Anxiety and Substance use Disorders: Neurobiological Basis and Clinical Application]. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Interventions for Demoralization in Patients With Cancer. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Psychedelic-Assisted Psychotherapy-A Systematic Review of Associated Psychological Interventions. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Psilocybin-Assisted Therapy: A Review of a Novel Treatment for Psychiatric Disorders. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Psilocybin history, action and reaction: A narrative clinical review. [2023]