Pragmatic Trial of Psilocybin Therapy in Palliative Care
ConditionDemoralization
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles S. Grob, M.D.
About this trial
This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form and the capacity to consent to research.
Stated willingness to comply with all study procedures and availability for the duration of the study
Is currently a patient in a study-engaged clinical site
Has a life-threatening illness and a life expectancy of ≤2 years
Disqualifiers
Known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine
Treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF)
If deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention
Cognitive impairment sufficient to impede the ability to complete study tasks
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin
DrugPsilocybin, \[3-\[2-(dimethylamino)ethyl\]-1H-indol-4-yl\] dihydrogen phosphate.
Ketamine
Drugketamine hydrochloride injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic and has a molecular formula of C13H16ClNO•HCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PsilocybinExperimental treatment 1 intervention
Group B: KetamineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in patient-reported Demoralization Scale-II..
The DS-II is a validated, patient-reported outcome assessing demoralization with a 2-week recall period.
Time frame
From Pre-dose V4 to ~14-days post drug (V8), and from Pre-dose (V4) to ~35-days post drug (V9), compared to active control.Secondary outcomes
1
i) Change in clinician-rated Clinical Global Impression (CGI) for Severity of demoralization.
The CGI-I is a widely used and validated assessment of global clinical improvement. Possible scores range "0=Not assessed", "1=Very much improved", to "7=Very much worse." The CGI-I has been adapted here for assessing improvement in demoralization.
Time frame
From Enrollment (V1) to ~14-days (V8) and ~35-days (V9) post-drug for patients treated with psilocybin therapy vs active control.2
ii) Odds ratio of meeting criteria for demoralization on the clinician-rated Demoralization Interview Interview (DI).
The CGI-I is a widely used and validated clinician-rated assessment of global clinical improvement. Possible scores range "0=Not assessed", "1=Very much improved", to "7=Very much worse." The CGI-I has been adapted here for assessing improvement in demoralization.
Time frame
From Enrollment (V1) to ~14-days (V8) and ~35-days (V9) post-drug for patients treated with psilocybin therapy vs active control.3
Change in depression symptoms
A comparison to active control using the following measures: PHQ-9, GRID-HAM-D6.compared to active control
Time frame
From Pre-dose V4 to ~14-days post drug (V8), and from Pre-dose V4 to ~35-days post drug (V9),4
Change in anxiety symptoms, quality of life, and spiritual well-being
A comparison to active control, using the following measures: GAD-7, FACIT-Pal-14 FACIT-Sp-12.
Time frame
From Enrollment (V1) to ~14-days post drug (V8), and Enrollment (V1) to ~35-days post drug (V9)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Charles S. Grob, M.D.
Lead sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor institution
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov