Status:
ACTIVE_NOT_RECRUITING
Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder
Lead Sponsor:
Keith Heinzerling
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 psilo...
Detailed Description
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 disord...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04410913
Start Date
February 18 2021
End Date
February 1 2023
Last Update
January 17 2023
Active Locations (1)
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1
Pacific Treatment & Research in Psychedelics
Santa Monica, California, United States, 90404