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New treatment option for Alcohol Use Disorder (AUD)
Official title Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
ClinicalTrials.gov ID: NCT06853912
What this study is testing
What is Psilocybin 25 mg?
Psilocybin 25 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alcohol use disorder (aud).
Also referred to as PEX010, PYEX.
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 study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner.
- 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 21 to 65
You may be able to join if
- Adults aged 21-65 who meet criteria for current DSM-5 diagnosis of AUD and PTSD as determined by the Alcohol System Checklist and CAPS-5.
- Are either a US military Veteran or are currently employed as a first responder, including EMT, paramedic, firefighter, or law enforcement officer.
- Report wanting to stop or decrease drinking and are willing to abstain from alcohol for the week prior to receiving any study drug.
- Are English-speaking.
- Must be willing to use contraception throughout the duration of the study. This applies to anyone, regardless of biological sex, who can cause...
You likely can't join if
- A reported history of known medical conditions that would preclude safe participation in the trial, including the following:
- seizure disorder,
- coronary artery disease,
- history of arrhythmia or known valvopathy,
- heart failure,
- cerebrovascular accident,
See the full eligibility criteria
- Adults aged 21-65 who meet criteria for current DSM-5 diagnosis of AUD and PTSD as determined by the Alcohol System Checklist and CAPS-5.
- Are either a US military Veteran or are currently employed as a first responder, including EMT, paramedic, firefighter, or law enforcement officer.
- Report wanting to stop or decrease drinking and are willing to abstain from alcohol for the week prior to receiving any study drug.
- Are English-speaking.
- Must be willing to use contraception throughout the duration of the study. This applies to anyone, regardless of biological sex, who can cause pregnancy or become pregnant themselves.
- Have a friend or family member who can pick them up and stay with them overnight after the DAS and who agrees to share contact information with the research team.
- Have a primary care provider.
- Have access to stable internet and either smart phone or computer.
- Are willing to disclose medication use, supplement use, and interventions they are currently enrolled in; and commit to all study-related activities and follow-up sessions.
- For the drug administration session, participants must be willing to reduce alcohol intake to be alcohol-free for 24 hours before DAS, fast after midnight before DAS, avoid caffeine and nicotine 2 hours before and 6-8...
- Must be locally accessible to the University of Washington for multiple in-person study visits.
- Must have a friend or someone else the participant trusts to stay with them overnight for the evening following the DAS.
- A reported history of known medical conditions that would preclude safe participation in the trial, including the following:
- seizure disorder,
- coronary artery disease,
- history of arrhythmia or known valvopathy,
- heart failure,
- cerebrovascular accident,
- severe asthma
- pulmonary hypertension,
- hyperthyroidism,
- stenosing peptic ulcer,
- pyloroduodenal obstruction,
- symptomatic prostatic hypertrophy,
- bladder-neck obstruction.
- Clinical findings on screening, including:
- significantly impaired liver function found in labs in prior 45-days or at screening
- uncontrolled hypertension (above 165/95 mmHg at screening)
- Serious ECG abnormalities measured at or within 45-days of screening (e.g., evidence of ischemia, myocardial infarction, QTc prolongation (QTc \> 0.45 seconds for men, QTc \> 0.47 seconds for women).
- Reported history or findings on SCID-CT of known exclusionary psychiatric conditions, including schizophrenia, schizoaffective disorder, bipolar disorder type I or type II.
- A reported history of a serious suicide attempt (SSA) in previous 12-months.
- A reported history of a personality disorder at time of screening.
- A reported family history of schizophrenia or schizoaffective disorder (first- or second-degree relatives), or bipolar disorder type 1 (first degree relatives).
- Currently using SSRIs, SNRIs, MAOIs, TCAs, antipsychotics, lithium, stimulants, or other psychedelics.
- Currently engaged in CBT, DBT, EMDR, psychoanalytic/psychodynamic therapy, MBSR, or unapproved group therapies, except for peer support groups.
- Cognitive impairment (Folstein Mini Mental State Exam score \< 26).
- A reported lifetime history of hallucinogen use disorder (per DSM-5).
- A reported history of cocaine, psychostimulant, or opioid use disorder defined by DSM-5 in the past 12 months, or currently utilizing full-agonist (methadone) or partial-agonist (buprenorphine) for OUD.
- Current or historical abuse of psychedelic/hallucinogenic substances (e.g. LSD, mushrooms/psilocybin, mescaline/peyote, MDMA, ketamine, ayahuasca, ibogaine, DMT, etc.) endorsed by participant or suspected by the Lead...
- Reported current non-medical use of cocaine, psychostimulants, psilocybin, or opioids (past 30 days).
- A reported history of significant alcohol withdrawal (CIWA-Ar score greater than 7) or a history of severe alcohol withdrawal, including delirium tremens, withdrawal seizures or any acute hospitalization related to...
- Serious abnormalities of complete blood count (CBC) or chemistries found at or within 45-days of screening.
- Currently enrolled in another clinical trial of any kind.
- Active legal problems with the potential to result in incarceration.
- Pregnancy or lactation; or intention to become pregnant or cause pregnancy
- Need to take medication with significant potential to interact with study medications (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents...
- Allergy or hypersensitivity to psilocybin.
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful...
- A previous diagnosis of Hallucination Perceptual Persisting Disorder (HPPD).
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months or 5 half-lives before enrollment or is currently enrolled in the treatment stage...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, 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, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, 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.