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Active, Not Recruiting

NCT Number: NCT04410913

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pacific Treatment & Research in Psychedelics

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin plus Visual Healing Set and Setting

Drug

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).

Psilocybin plus Standard Set and Setting

Drug

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).

Primary outcomes

  1. Feasibility: Recruitment Rate

    Time frame: Week 10

    Enroll at least 70% of target number of participants

  2. Feasibility: Retention Rate

    Time frame: week 10

    Participants complete at least 70% of post-randomization visits

  3. Tolerability: Number of Visual Healing segments viewed by participants

    Time frame: Week 7

    Average number of segments viewed

  4. Safety/Tolerability: number of Adverse Events

    Time frame: Week 14

    Average number of adverse events (side effects)

  5. Safety: Systolic Blood Pressure

    Time frame: Week 14

    Systolic blood pressure during dosing sessions

  6. Safety: Diastolic Blood Pressure

    Time frame: Week 14

    Diastolic blood pressure during dosing sessions

  7. Safety: Heart rate

    Time frame: Week 14

    Heart rate during dosing sessions

  8. Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score

    Time frame: Week 14

    Average change in anxiety scale score from prep session to dosing session

  9. Safety: Challenging Experience Questionnaire (CEQ)

    Time frame: Week 14

    Average score on challenging psychedelic experience scale

  10. Safety: Questionnaire for Psychotic Experiences

    Time frame: Week 14

    Average score on psychosis symptom scale

Sponsors and collaborators

Lead sponsor

Keith Heinzerling

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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