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临床试验/NCT05403086
NCT05403086招募中2 期

Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC): A Multicenter Triple-blind Phase 2 Randomized Controlled Trial of Psilocybin Therapy for Demoralized Adults Near the End of Life

Charles S. Grob, M.D.5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
100
试验地点
5
主要终点
Change in patient-reported Demoralization Scale-II..

研究概览

简要总结

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).

详细描述

After providing written informed consent, participants deemed eligible for this trial will be randomized to a brief course of talk therapy plus 1 dose of oral psilocybin vs the same brief course of talk therapy plus 1 dose of oral ketamine (the active control). Participants' degree of demoralization and other clinical outcomes (e.g., depression, anxiety) will be assessed at 1, 2, and 5 weeks after the study drug administration. After completing the study, participants will have the option of being told which study drug they took (aka, "unblinded"); those who were randomized to the active control will be offered another brief course of talk therapy plus 1 dose of oral psilocybin, and the same sequence of outcome assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

A Multicenter Triple-blind Phase 2 Randomized Controlled Trial.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • Has moderate-to-severe demoralization
  • Ability to take oral medication (capsules and liquid)

排除标准

  • 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
  • Neurological
  • Cognitive impairment sufficient to impede the ability to complete study tasks
  • History of intracranial hemorrhage
  • Recent embolic stroke
  • Recent seizure
  • Current intracranial mass
  • Advanced stage of a neurologic disease that elevates risk for psychosis
  • Cardiovascular
  • Uncontrolled hypertension
  • Clinically significant cardiac disease
  • Respiratory
  • Severe pulmonary disease
  • Supplemental oxygen requirement
  • Gastrointestinal
  • Current intractable nausea/vomiting/diarrhea
  • Recent, clinically significant GI bleed
  • Markedly abnormal liver function tests
  • Endocrine, Renal, and Reproductive
  • Pregnancy or lactation
  • Severe renal insufficiency
  • Unstable insulin-dependent diabetes mellitus
  • Prohibited Medications
  • Antipsychotics (with exceptions)
  • Antidepressants (with exceptions)
  • Dopamine agonists
  • Drugs known to have adverse interactions with psilocybin or ketamine

研究组 & 干预措施

Psilocybin

Experimental

A single moderate-to-high dose of oral psilocybin, plus 4-5 sessions of a brief, existential psychotherapy.

干预措施: Psilocybin (Drug)

Ketamine

Active Comparator

A single low-to-moderate dose of oral liquid ketamine, plus 4-5 sessions of a brief, existential psychotherapy.

干预措施: Ketamine (Drug)

结局指标

主要结局

Change in patient-reported Demoralization Scale-II..

时间窗: 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.

The DS-II is a validated, patient-reported outcome assessing demoralization with a 2-week recall period.

次要结局

  • i) Change in clinician-rated Clinical Global Impression (CGI) for Severity of demoralization.(From Enrollment (V1) to ~14-days (V8) and ~35-days (V9) post-drug for patients treated with psilocybin therapy vs active control.)
  • DS-II and PHQ-9 comparison measures assessment(Throughout the study)
  • ii) Odds ratio of meeting criteria for demoralization on the clinician-rated Demoralization Interview Interview (DI).(From Enrollment (V1) to ~14-days (V8) and ~35-days (V9) post-drug for patients treated with psilocybin therapy vs active control.)
  • Change in patient-reported pain(From Enrollment (V1) to ~14-days post drug (V8), and from Enrollment (V1) to ~35-days post drug (V9),)
  • Change in depression symptoms(From Pre-dose V4 to ~14-days post drug (V8), and from Pre-dose V4 to ~35-days post drug (V9),)
  • Change in anxiety symptoms, quality of life, and spiritual well-being(From Enrollment (V1) to ~14-days post drug (V8), and Enrollment (V1) to ~35-days post drug (V9))
  • Associations will be explored between change in Demoralization Scale-II and other measures pre-dose and 7 days post drug(From Pre-dose (V4) to 7-days post-drug.)

研究者

发起方
Charles S. Grob, M.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Charles S. Grob, M.D.

Professor of Psychiatry and Behavioral Sciences

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

研究点 (5)

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