Alcohol Use Disorder
Conditions
Keywords
Psilocybin, Psychedelics, Alcohol Use Disorder, Alcoholism, Psychedelic-assisted Therapy
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 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.
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 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.
Interventions
DRUGPsilocybin plus Visual Healing Set and Setting
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).
DRUGPsilocybin plus Standard Set and Setting
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).
Sponsors
Keith Heinzerling
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Recruitment Rate | Week 10 | Enroll at least 70% of target number of participants |
| Feasibility: Retention Rate | week 10 | Participants complete at least 70% of post-randomization visits |
| Tolerability: Number of Visual Healing segments viewed by participants | Week 7 | Average number of segments viewed |
| Safety/Tolerability: number of Adverse Events | Week 14 | Average number of adverse events (side effects) |
| Safety: Systolic Blood Pressure | Week 14 | Systolic blood pressure during dosing sessions |
| Safety: Diastolic Blood Pressure | Week 14 | Diastolic blood pressure during dosing sessions |
| Safety: Heart rate | Week 14 | Heart rate during dosing sessions |
| Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score | Week 14 | Average change in anxiety scale score from prep session to dosing session |
| Safety: Challenging Experience Questionnaire (CEQ) | Week 14 | Average score on challenging psychedelic experience scale |
| Safety: Questionnaire for Psychotic Experiences | Week 14 | Average score on psychosis symptom scale |
Countries
United States
Outcome results
None listed