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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder (AUD), PTSD

In brief

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.

Key facts

Study ID

NCT06853912

Run by

Nathan Brashares Sackett

People needed

40

Starts

2025-06-01

Expected to finish

2026-06-01

Last updated by the study team

2025-08-28

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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 hours after DAS, and avoid driving for 24 hours post-DAS.
• 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.

You may not qualify 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,
• 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).

Where it is running

• University of Washington Center for Novel Therapeutics in Addiction Psychiatry — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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