A Phase 2 interventional study of Psilocybin plus Visual Healing Set and Setting and Psilocybin plus Standard Set and Setting in Alcohol Use Disorder, sponsored by Keith Heinzerling. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by Keith Heinzerling · Phase 2, Interventional, and Treatment
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 20 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →This is the only study on the registry with Keith Heinzerling as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 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).
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).
Feasibility: Recruitment Rate
Enroll at least 70% of target number of participants
Time frame: Week 10
Feasibility: Retention Rate
Participants complete at least 70% of post-randomization visits
Time frame: week 10
Tolerability: Number of Visual Healing segments viewed by participants
Average number of segments viewed
Time frame: Week 7
Safety/Tolerability: number of Adverse Events
Average number of adverse events (side effects)
Time frame: Week 14
Safety: Systolic Blood Pressure
Systolic blood pressure during dosing sessions
Time frame: Week 14
Safety: Diastolic Blood Pressure
Diastolic blood pressure during dosing sessions
Time frame: Week 14
Safety: Heart rate
Heart rate during dosing sessions
Time frame: 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
Time frame: Week 14
Safety: Challenging Experience Questionnaire (CEQ)
Average score on challenging psychedelic experience scale
Time frame: Week 14
Safety: Questionnaire for Psychotic Experiences
Average score on psychosis symptom scale
Time frame: Week 14
This study is active, not recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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