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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)

A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD) (NCT06853912) is a Phase 2 interventional studying Alcohol Use Disorder (AUD) and PTSD, sponsored by Nathan Brashares Sackett. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Alcohol Use Disorder (AUD) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Psilocybin 25 mg

Botanical drug product PEX010(25) contains the drug substance, PYEX, which is primarily composed of psilocybin (delivered in a capsule)

DRUG

Maltodextrin (Placebo)

25 mg of Maltodextrin (delivered in a capsule)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Washington Center for Novel Therapeutics in Addiction Psychiatry
Seattle, Washington, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06853912), the sponsor (Nathan Brashares Sackett), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06853912 clinical trial studying?

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 p… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06853912?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06853912?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06853912. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06853912. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.