Skip to content
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)

NCT06853912 · Psi-PS · Nathan Brashares Sackett

Closed to entry
Status
Not accepting participants
Phase 2
Phase
40
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Safety of Psi-PS

    Measured over Within approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. 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. 2. Are either a US military Veteran or are currently employed as a first responder, including EMT, paramedic, firefighter, or law enforcement officer. 3. Report wanting to stop or decrease drinking and are willing to abstain from alcohol for the week prior to receiving any study drug. 4. Are English-speaking. 5. 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. 6. 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. 7. Have a primary care provider. 8. Have access to stable internet and either smart phone or computer. 9. 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. 10. 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 hours after DAS, and avoid driving for 24 hours post-DAS. 11. Must be locally accessible to the University of Washington for multiple in-person study visits. 12. Must have a friend or someone else the participant trusts to stay with them overnight for the evening following the DAS. Exclusion Criteria: 1. 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. 2. 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). 3. Reported history or findings on SCID-CT of known exclusionary psychiatric conditions, including schizophrenia, schizoaffective disorder, bipolar disorder type I or type II. 4. A reported history of a serious suicide attempt (SSA) in previous 12-months. 5. A reported history of a personality disorder at time of screening. 6. A reported family history of schizophrenia or schizoaffective disorder (first- or second-degree relatives), or bipolar disorder type 1 (first degree relatives). 7. Currently using SSRIs, SNRIs, MAOIs, TCAs, antipsychotics, lithium, stimulants, or other psychedelics. 8. Currently engaged in CBT, DBT, EMDR, psychoanalytic/psychodynamic therapy, MBSR, or unapproved group therapies, except for peer support groups. 9. Cognitive impairment (Folstein Mini Mental State Exam score \< 26). 10. A reported lifetime history of hallucinogen use disorder (per DSM-5). 11. 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. 12. 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 Investigator's clinical judgement. 13. Reported current non-medical use of cocaine, psychostimulants, psilocybin, or opioids (past 30 days). 14. 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 alcohol withdrawal. Participants presenting at screening in withdrawal may be referred for detoxification and reassessed within 30 days. 15. Serious abnormalities of complete blood count (CBC) or chemistries found at or within 45-days of screening. 16. Currently enrolled in another clinical trial of any kind. 17. Active legal problems with the potential to result in incarceration. 18. Pregnancy or lactation; or intention to become pregnant or cause pregnancy 19. 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, lithium, anticonvulsants) as determined by Study Physician or Lead Investigator. 20. Allergy or hypersensitivity to psilocybin. 21. 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 social support), or deemed not suitable for other reasons stipulated by the research team. 22. A previous diagnosis of Hallucination Perceptual Persisting Disorder (HPPD). 23. 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 of an investigational study.

Where

1 study site

FacilityCityRegionCountry
University of Washington Center for Novel Therapeutics in Addiction PsychiatrySeattleWashingtonUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06853912 on ClinicalTrials.gov →

Last updated in the registry 2026-08-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits