Psilocybin with Psychological Support for Veterans and First Responders with PTSD & Alcohol Use Disorder
This study is testing if psilocybin (25 mg), combined with psychological support, is safe for military veterans and first responders (like EMTs or firefighters) who have both Post-Traumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). About 40 participants, aged 21-65, will receive either psilocybin (PEX010(25)) or a placebo (maltodextrin) in a capsule. The main goal is to see how safe this treatment is during and shortly after the drug administration session. This is the first study to look at psilocybin-assisted therapy for people with both PTSD and AUD.
- Study design
- This is a Phase 2, single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase, planning to enroll about 40 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured within approximately 24 hours and one week after the drug administration session.
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NCT06853912
PsiloStudy: Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
Active, Not Recruiting
PHASE2Ages 21–65InterventionalTreatmentNathan Brashares SackettInvestigator-initiated
~40 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Psilocybin 25 mgMaltodextrin (Placebo)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Nathan B Sackett, MD · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
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.
What this trial measures
- Safety of Psi-PSWithin approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS.
Safety of Psi-PS will be measured through the assessment of adverse events (AEs), serious adverse events (SAEs), and acute suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS).