Active, Not RecruitingPhase 2psilocybin

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

NCT ID

NCT04410913

Target Enrollment

20 participants

Start Date

2021-02-18

Est. Completion

2023-02

About This Study

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.

Conditions Studied

Alcohol Use Disorder

Interventions

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

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Pacific Treatment & Research in Psychedelics