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Tests treatment safety and results for Demoralization
Official title Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer
ClinicalTrials.gov ID: NCT06818994
What this study is testing
What is Psilocybin-assisted Psychotherapy?
Psilocybin-assisted Psychotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for demoralization.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients diagnosed with advanced stage cancer (stages 3 and 4)
- Aged between 18 and 70 years.
- Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30
- English proficiency
- Ability to understand and the willingness to sign a written informed consent document.
You likely can't join if
- Condition impairing oral intake or digestive absorption.
- Primary brain tumor.
- Presence of delirium.
- Significant suicide risk as defined by suicidal ideation with intent and a plan.
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective...
- Patients with first-degree relatives with schizophrenia or bipolar disorder
See the full eligibility criteria
- Patients diagnosed with advanced stage cancer (stages 3 and 4)
- Aged between 18 and 70 years.
- Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30
- English proficiency
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals of child-bearing potential who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study...
- Condition impairing oral intake or digestive absorption.
- Primary brain tumor.
- Presence of delirium.
- Significant suicide risk as defined by suicidal ideation with intent and a plan.
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical...
- Patients with first-degree relatives with schizophrenia or bipolar disorder
- Previous diagnosis of epilepsy, stroke or Transient Ischemic Attack (TIA), dementia, and Parkinson's disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin.
- Other personal circumstances and behavior that would limit compliance with study requirements or that are judged by the study psychiatrist and/or principal investigator to be incompatible with establishing rapport or...
- Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:
- MAO inhibitors
- Patients currently on antipsychotics (e.g. first and second generation) when taken regularly (6 weeks or less prior to screening visit)
- Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)
- Aldehyde dehydrogenase inhibitors (e.g. disulfiram)
- Significant inhibitors of UGT 1A0 or UGT 1A10
- Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork performed at screening and patients with symptoms suggestive of liver failure including confusion...
- Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the...
- Women who are pregnant, nursing, or planning a pregnancy.
- Use of a classic psychedelic or MDMA in the last 12 months
The study team makes the final eligibility decision.
Where it's taking place
- Kingston, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingston, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.