This open-label trial (n=20) investigates if psilocybin (25mg, 2x) and Visual Healing (an ‘optimised’ set and setting using VR with a nature theme) will be significantly better in treating those with alcohol use disorder than a ‘standard’ set and setting.
Both groups will get one session without Visual Healing and have the option of choosing this in the second session. The difference between the groups is the “chance to view nature-themed videos before and after the psychedelic sessions.“
Compound Psilocybin
Country United States of America
Visit trial
Status
Active, not recruiting
Results Published
No
Start date
01 March 2021
End date
01 July 2022
Chance of happening
100%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
20
Sex
All
Age
18- 99
Therapy
Yes
Trial Details
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.NCT Number NCT04410913
Sponsors & Collaborators
John Wayne Cancer InstituteThis company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Nature-themed video intervention may improve cardiovascular safety of psilocybin-assisted therapy for alcohol use disorderThis open-label pilot study (n=20) investigated the use of Visual Healing, a nature-themed video intervention, to enhance set and setting in psychedelic-assisted therapy with psilocybin for alcohol use disorder (AUD). Participants were randomized to either use Visual Healing or standard procedures during two psilocybin dosing sessions. The study found that Visual Healing was feasible, safe, and well-tolerated, with participants viewing the videos without adverse events. It also noted a significant decrease in alcohol use in both groups and found that Visual Healing did not interfere with the psychedelic experience or treatment outcomes related to alcohol use. The study suggests that Visual Healing may reduce cardiovascular risks in psychedelic therapy and calls for further research to replicate these findings and explore set and setting interventions with other psychedelic medications and indications.