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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keith Heinzerling
• Treatments: Psilocybin

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