Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Drug: Psilocybin plus Visual Healing Set and Setting
* Drug: Psilocybin plus Standard Set and Setting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 Epilepsy Insulin-dependent diabetes Diabetes and taking oral hypoglycemic agent with a history of hypoglycemia requiring serious medical intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visual Healing Set and Setting<br>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. | Drug: Psilocybin plus Visual Healing Set and Setting<br>* Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).<br>|
| Active Comparator: Standard Set and Setting<br>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. | Drug: Psilocybin plus Standard Set and Setting<br>* Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Recruitment Rate | Enroll at least 70% of target number of participants | Week 10 | 
| Feasibility: Retention Rate | Participants complete at least 70% of post-randomization visits | week 10 | 
| Tolerability: Number of Visual Healing segments viewed by participants | Average number of segments viewed | Week 7 | 
| Safety/Tolerability: number of Adverse Events | Average number of adverse events (side effects) | Week 14 | 
| Safety: Systolic Blood Pressure | Systolic blood pressure during dosing sessions | Week 14 | 
| Safety: Diastolic Blood Pressure | Diastolic blood pressure during dosing sessions | Week 14 | 
| Safety: Heart rate | Heart rate during dosing sessions | Week 14 | 
| Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score | Average change in anxiety scale score from prep session to dosing session | Week 14 | 
| Safety: Challenging Experience Questionnaire (CEQ) | Average score on challenging psychedelic experience scale | Week 14 | 
| Safety: Questionnaire for Psychotic Experiences | Average score on psychosis symptom scale | Week 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psilocybin, Psychedelics, Alcohol Use Disorder, Alcoholism, Psychedelic-assisted Therapy