Alcohol Use Disorder study: Psilocybin
Official title Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
ClinicalTrials.gov ID: NCT06349083
What this study is testing
What is Psilocybin?
An investigational oral capsule being studied as a potential treatment for alcohol use disorder. Psilocybin is designed to act as a serotonin 5‑HT2A receptor agonist, which may alter brain activity and perception.
Also referred to as magic mushrooms.
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
- The study wants to find out if psilocybin changes brain responses to negative feelings and alcohol images, and whether those changes relate to less drinking.
- Who it's for
- It is looking for adults who have alcohol use disorder.
- What's involved
- Participants will receive either psilocybin or a placebo, then have brain scans (fMRI) and give blood samples and fill out questionnaires about drinking and mood.
- Time commitment
- The study lasts several weeks, with multiple visits for scans, blood draws, and questionnaires.
- 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.
- Are 18 to 65 years old, inclusive, at Screening visit.
- Have DSM-5 diagnosis of moderate or severe AUD (using MINI)
You likely can't join if
- Pregnancy or lactation
- Seizure disorder
- Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 × upper limit of...
- Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart...
- Uncontrolled hypertension with systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg.
- Resting heart rate \> 100 bpm (Note: participants will have an opportunity to return once within the 30 day screening window to make 3 additional...
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.
- Are able to read, speak, and understand English, as documented during the informed consent process. a.
- Are 18 to 65 years old, inclusive, at Screening visit.
- Have DSM-5 diagnosis of moderate or severe AUD (using MINI)
- Eligible participants must either (a) not currently receiving treatment for alcohol use disorder (AUD), or (b) have been in continuous treatment for AUD for at least 3 months and plan to continue.
- 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 the screening visit.
- Agree to refrain from alcohol use as well as any non-prescribed psychotropic substance or illicit drug use for at least 24 hours prior to investigational product (IP) administration and 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.
- If able to become pregnant, have a negative serum pregnancy test at screening.
- 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.
- Participants must be able to commit to being sober at the time all treatment sessions and the two fMRI sessions, and to stay sober from the time of the drug administration until the second fMRI session.
What rules you out
- Pregnancy or lactation
- Seizure disorder
- Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 × upper limit of normal (ULN)
- Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart failure, history of heart valve replacement, and history of...
- Uncontrolled hypertension with systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg.
- Resting heart rate \> 100 bpm (Note: participants will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a resting heart rate ≤ 100 bpm.).
- Serious ECG abnormalities present on the ECG obtained at the screening visit (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate [QTc] prolongation (QTc \> 0.450 seconds)...
- Hyperthyroidism
- Insulin-dependent diabetes
- Any other medical condition which precludes safe participation in the study in the medical opinion of the Investigator. (Note: medical history will be updated on Day 0.
- 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) (past week severity score \>3) at the Screening visit, confirmed by the Investigator.
- 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 treatment or are a prisoner.
- 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).
- 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), including presence of metallic implants or devices that contraindicate MRI or claustrophobia.
- Any history of severe traumatic brain injury (assessed using OSU TBI-ID modified). (Note: If current (past 12 months) mild/moderate TBI and CSI score \>/=12 (for either lifetime month or current month), the PI will...
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.