PsiloStudy: Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Respon… (NCT06853912) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PsiloStudy: Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
United States40 participantsStarted 2025-06-01
Plain-language summary
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. We hypothesize that Psi-PS may provide a safe treatment for participants. The primary objective of study is to characterize the safety of psilocybin combined with psychological support (Psi-PS) for individuals with co-occurring alcohol use disorder (AUD) and PTSD.
Who can participate
Age range
21 Years – 65 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
. 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.
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
Safety of Psi-PS
Timeframe: Within approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS.
. Have access to stable internet and either smart phone or computer.
Exclusion criteria
. A reported history of known medical conditions that would preclude safe participation in the trial, including the following:
. Clinical findings on screening, including:
. 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.