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Active, not recruitingPhase 2

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

NCT04410913 · Keith Heinzerling

Closed to entry
Status
Not accepting participants
Phase 2
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Feasibility: Recruitment Rate

    Measured over Week 10

  • Feasibility: Retention Rate

    Measured over week 10

  • Tolerability: Number of Visual Healing segments viewed by participants

    Measured over Week 7

  • Safety/Tolerability: number of Adverse Events

    Measured over Week 14

  • Safety: Systolic Blood Pressure

    Measured over Week 14

  • Safety: Diastolic Blood Pressure

    Measured over Week 14

  • Safety: Heart rate

    Measured over Week 14

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

    Measured over Week 14

  • Safety: Challenging Experience Questionnaire (CEQ)

    Measured over Week 14

  • Safety: Questionnaire for Psychotic Experiences

    Measured over Week 14

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
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

Where

1 study site

FacilityCityRegionCountry
Pacific Treatment & Research in PsychedelicsSanta MonicaCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04410913 on ClinicalTrials.gov →

Last updated in the registry 2023-01-17. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in