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

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.

Intervention / Treatment

  • Drug: Psilocybin plus Visual Healing Set and Setting
  • Drug: Psilocybin plus Standard Set and Setting

Condition or Disease

  • Alcohol Use Disorder

Phase

Study Design

Study type: Interventional
Status: Active, not recruiting
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 20 ()
Funded by: Other

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Clinical Trial Dates

Start date: Feb 18, 2021
Primary Completion: Jul 01, 2022
Completion Date: Jul 01, 2022
Study First Posted: Jun 01, 2020
Results First Posted: Aug 30, 2020
Last Updated: Jan 31, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 18

More Details

NCT Number: NCT04410913
Other IDs: PTRIP002
Study URL: https://ClinicalTrials.gov/show/NCT04410913
Last updated: Jun 16, 2022