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New treatment option for Alcohol Use Disorder
Official title Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
ClinicalTrials.gov ID: NCT06349083
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Are able to provide voluntary informed consent
- Have a breath alcohol concentration (BrAC) ≤ 0.01% at screening, as determined by a breath alcohol reading from a calibrated breath alcohol sensor...
- Are able to read, speak, and understand English, as documented during the informed consent process. a. Non-English speaking people will be excluded...
- Are 18 to 65 years old, inclusive, at Screening visit.
- Have DSM-5 diagnosis of moderate or severe Alcohol Use Disorder (AUD) (using MINI)
You likely can't join if
- Pregnancy or lactation
- Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical...
- Have any of the following DSM-5 psychiatric disorders, as determined by the MINI and Psychiatric History AT the Screening Visit: (Note: psychiatric...
- Lifetime history of schizophrenia spectrum or other psychotic disorder (including substance or medication-induced psychosis or psychosis due to a...
- Current alcohol withdrawal (CIWA-Ar score \>7)
- History of mania
See the full eligibility criteria
Who can join
- Are able to provide voluntary informed consent
- Have a breath alcohol concentration (BrAC) ≤ 0.01% at screening, as determined by a breath alcohol reading from a calibrated breath alcohol sensor. (Note: this criterion may be re-evaluated within the 30-day screening...
- Are able to read, speak, and understand English, as documented during the informed consent process. a. Non-English speaking people will be excluded because the study is using only validated English-language versions of...
- Are 18 to 65 years old, inclusive, at Screening visit.
- Have DSM-5 diagnosis of moderate or severe Alcohol Use Disorder (AUD) (using MINI)
- Are in treatment at Silver Hill Hospital (either in Residential Treatment program, or Inpatient with plan to enter Residential Treatment Program)
- Are able and willing to adhere to all study requirements, including attending all study visits and therapy sessions, and completing all assessments.
- Have least 4 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to admission to SHH
- Agree to refrain from any non-prescribed psychotropic substance or illicit drug use for at least 72 hours prior to investigational product (IP) administration, and for at least 24 hours before each fMRI assessment...
- Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator.
- Are able to swallow capsules.
- Have a negative pregnancy test at screening, Baseline, Day 0 (pre-IP administration); and Day 2.
- If able to become pregnant or produce viable sperm (male or female), are willing to use approved contraception for duration of the trial
- Able to provide at least 2 locators.
What rules you out
- Pregnancy or lactation
- Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests...
- Have any of the following DSM-5 psychiatric disorders, as determined by the MINI and Psychiatric History AT the Screening Visit: (Note: psychiatric history will be re-evaluated on Day 0, but the MINI will not be...
- Lifetime history of schizophrenia spectrum or other psychotic disorder (including substance or medication-induced psychosis or psychosis due to a co-occurring medical condition).
- Current alcohol withdrawal (CIWA-Ar score \>7)
- History of mania
- Have active suicidal ideation with intent, based on Columbia-Suicide Severity Rating Scale (C-SSRS assessment (severity score \>3) at the Screening visit, confirmed by the Investigator. (Note: this criterion will be...
- Have made a medically significant suicide attempt (i.e., one that had a significant possibility of causing death or permanent harm in the absence of intervention) within the past 12 months, based on Screening C-SSRS...
- Have a family history (first degree relatives) of schizophrenia, schizoaffective disorder, or bipolar disorder type 1.
- Have a history of hallucinogen use disorder.
- Have a history of hallucinogen persisting perceptual disorder (HPPD).
- Have any use of classic psychedelics in the past 1 year.
- Have \> 25 lifetime uses of classic psychedelics.
- Incarcerated or have pending legal action that could prevent participation in study activities.
- Are court-mandated to complete residential treatment at SHH
- Are unable or unwilling to discontinue taking any protocol-prohibited medications and supplements. (A detailed list of exclusionary medications is found in Section 6.5 of the protocol) Prohibited medications and...
- Have a known allergy or hypersensitivity to psilocybin or any of the materials contained in the IP used in the study.
- Have an allergy, hypersensitivity, or other contraindication that would preclude safe treatment of acute hypertension, anxiety, or psychotic symptoms if necessary during or immediately after the IP Administration...
- Have any other medical, psychiatric, or psychosocial disorder, symptom, condition, or situation that is likely to interfere with the establishment of rapport, adherence to study requirements, or safe administration of...
- Inability to safely complete fMRI sessions (MRI screening form)
- Any history of severe traumatic brain injury (assessed using the Ohio State University Traumatic Brain Injury (TBI) Identification [OSU TBI-ID] modified). (Note: If current (past 12 months) mild/moderate TBI and CSI...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.