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

Sponsor

Keith Heinzerling (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04410913

Collaborator

(none)

Enrollment

Location

Arms

16.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: Psilocybin plus Visual Healing Set and Setting Drug: Psilocybin plus Standard Set and Setting	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel assignmentParallel assignment

Masking:

None (Open Label)

Masking Description:

Open Label

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 18, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Visual Healing Set and Setting 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 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).
Active Comparator: Standard Set and Setting 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 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).

Arm

Intervention/Treatment

Experimental: Visual Healing Set and Setting

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

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).

Active Comparator: Standard Set and Setting

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

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).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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