Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder (NCT04410913) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder
United States20 participantsStarted 2021-02-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility: Recruitment Rate
Timeframe: Week 10
2
Feasibility: Retention Rate
Timeframe: week 10
3
Tolerability: Number of Visual Healing segments viewed by participants
Timeframe: Week 7
4
Safety/Tolerability: number of Adverse Events
Timeframe: Week 14
5
Safety: Systolic Blood Pressure
Timeframe: Week 14
6
Safety: Diastolic Blood Pressure
Timeframe: Week 14
7
Safety: Heart rate
Timeframe: Week 14
8
Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score