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临床试验/NCT04410913
NCT04410913进行中(未招募)2 期

Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder

Keith Heinzerling1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2月18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
进行中(未招募)
发起方
入组人数
20
试验地点
1
主要终点
Safety: Questionnaire for Psychotic Experiences

研究概览

简要总结

Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to open-label psilocybin (25 mg) therapy with the Visual Healing Set and Setting platform (N=10) versus psilocybin (25 mg) with a standard Set and Setting platform (N=10). The purpose of this study is to evaluate the feasibility, safety, and tolerability of adding Visual Healing, a nature-themed virtual immersive program, to psilocybin-assisted therapy among participants with alcohol use disorder.

详细描述

The objective of the study is to test a strategy for optimizing Set and Setting for psilocybin-assisted therapy of alcohol use disorder. Psilocybin shows promise in early trials for alcohol use disorder, but initial results suggest that patients with alcohol use disorder may be less likely to achieve a mystical experience with standard doses of psilocybin. Optimizing Set and Setting for the psilocybin experience may improve outcomes without requiring higher drug doses. The current study will complete a pilot randomized clinical trial to assess the feasibility, safety, and tolerability of Visual Healing Set and Setting (N=10) versus standard Set and Setting procedures (N=10) in participants with alcohol use disorder undergoing open-label psilocybin 25 mg therapy. In the Visual Healing condition, participants will view nature-themed video programs during the Prep session and during the Ascent phase of the psilocybin experience. Anecdotal reports and reviews suggest that viewing Visual Healing creates a tranquil and calming environment that fosters a stronger connection between the viewer and nature. Psilocybin increases the users feeling of connection to nature and having an intention to connect with nature during the psychedelic session is associated with better outcomes of psychedelic-assisted therapy in initial studies. Reducing pre-dosing anxiety/apprehension and enhancing connections to nature with Visual Healing may improve outcomes of psychedelic-assisted therapy without the need for higher psilocybin doses.

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
None

盲法说明

Open Label

入排标准

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

入选标准

  • •Age 18 or older
  • •Able to read, speak, and understand English
  • •Alcohol use disorder, moderate-severe, according to DSM-5 criteria
  • •Interested in stopping or reducing alcohol use
  • •Able and willing to adhere to study requirements, including attending all study visits, preparatory, and follow-up sessions, and completing all study evaluations
  • •Able to swallow capsules
  • •Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of the study
  • •Have an identified support person
  • •Agree to be driven home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing

排除标准

  • •Alcohol withdrawal requiring medical intervention
  • •Women who are pregnant, or women who intend to become pregnant during the study or who are currently nursing
  • •Unwilling or unable to discontinue formal alcohol use disorder treatment
  • •Significant current or history of cardiovascular condition
  • •Have a history of stroke or Transient Ischemic Attack (TIA)
  • •Moderate to severe liver impairment
  • •Insulin-dependent diabetes
  • •Diabetes and taking oral hypoglycemic agent with a history of hypoglycemia requiring serious medical intervention

研究组 & 干预措施

Standard Set and Setting

Active Comparator

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

干预措施: Psilocybin plus Standard Set and Setting (Drug)

Visual Healing Set and Setting

Experimental

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

干预措施: Psilocybin plus Visual Healing Set and Setting (Drug)

结局指标

主要结局

Safety: Questionnaire for Psychotic Experiences

时间窗: Week 14

Average score on psychosis symptom scale

Feasibility: Recruitment Rate

时间窗: Week 10

Enroll at least 70% of target number of participants

Feasibility: Retention Rate

时间窗: week 10

Participants complete at least 70% of post-randomization visits

Safety: Systolic Blood Pressure

时间窗: Week 14

Systolic blood pressure during dosing sessions

Safety: Heart rate

时间窗: Week 14

Heart rate during dosing sessions

Safety: Challenging Experience Questionnaire (CEQ)

时间窗: Week 14

Average score on challenging psychedelic experience scale

Tolerability: Number of Visual Healing segments viewed by participants

时间窗: Week 7

Average number of segments viewed

Safety/Tolerability: number of Adverse Events

时间窗: Week 14

Average number of adverse events (side effects)

Safety: Diastolic Blood Pressure

时间窗: Week 14

Diastolic blood pressure during dosing sessions

Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score

时间窗: Week 14

Average change in anxiety scale score from prep session to dosing session

次要结局

未报告次要终点

研究者

发起方
Keith Heinzerling
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Keith Heinzerling

Director, Pacific Treatment & Research In Psychedelics Program

Saint John's Cancer Institute

研究点 (1)

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