Actively Recruiting

Phase 2
Age: 21Years - 65Years
All Genders
NCT06853912

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

Led by Nathan Brashares Sackett · Updated on 2025-08-28

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

N

Nathan Brashares Sackett

Lead Sponsor

W

Washington State Legislation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 21 to 65 with current diagnosis of both alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD)
  • Military veterans or currently employed as first responders including EMTs, paramedics, firefighters, or law enforcement officers
  • Want to stop or reduce drinking and willing to abstain from alcohol for one week before study drug
  • English-speaking
  • Willing to use contraception during the study if able to cause or become pregnant
  • Have a friend or family member able to stay overnight after drug administration and share contact info with study team
  • Have a primary care provider
  • Access to stable internet and a smartphone or computer
  • Willing to disclose medication and supplement use and complete all study activities and follow-ups
  • Able to be alcohol-free for 24 hours before drug administration session, fast after midnight before session, avoid caffeine and nicotine 2 hours before and 6-8 hours after session, and avoid driving for 24 hours post-session
  • Live locally and able to attend multiple in-person visits at the University of Washington
  • Have someone trusted to stay overnight after drug administration session
Not Eligible

You will not qualify if you...

  • Medical conditions that make participation unsafe, including seizure disorder, coronary artery disease, arrhythmia, valvopathy, heart failure, stroke, severe asthma, pulmonary hypertension, hyperthyroidism, peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder-neck obstruction
  • Abnormal clinical findings such as impaired liver function, uncontrolled hypertension (>165/95 mmHg), or serious ECG abnormalities within 45 days
  • Psychiatric conditions including schizophrenia, schizoaffective disorder, bipolar disorder type I or II
  • Serious suicide attempt within past 12 months
  • Personality disorder
  • Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1
  • Current use of SSRIs, SNRIs, MAOIs, TCAs, antipsychotics, lithium, stimulants, or other psychedelics
  • Currently engaged in certain psychotherapies except peer support groups
  • Cognitive impairment (Mini Mental State Exam score < 26)
  • Lifetime history of hallucinogen use disorder
  • Recent history (past 12 months) of cocaine, psychostimulant, or opioid use disorder or current use of methadone or buprenorphine
  • Current or past abuse of psychedelics/hallucinogens as determined by investigator
  • Current non-medical use of cocaine, psychostimulants, psilocybin, or opioids in past 30 days
  • History of significant or severe alcohol withdrawal
  • Abnormal blood counts or chemistries within 45 days
  • Currently enrolled in another clinical trial
  • Active legal issues risking incarceration
  • Pregnancy, lactation, or intention to become pregnant or cause pregnancy
  • Need to take medications that may interact with study drugs
  • Allergy or sensitivity to psilocybin
  • High risk of adverse emotional or behavioral reactions or unsuitable for other reasons
  • Diagnosis of Hallucination Perceptual Persisting Disorder (HPPD)
  • Recent use of investigational drugs or devices within 3 months or 5 half-lives before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Washington Center for Novel Therapeutics in Addiction Psychiatry

Seattle, Washington, United States, 98195

Actively Recruiting

Loading map...

Research Team

C

Christina Sargent

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here