RecruitingPhase 2NCT06853912

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)


Sponsor

Nathan Brashares Sackett

Enrollment

40 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether psilocybin (the active compound in "magic mushrooms"), combined with psychological support, can help military veterans and first responders who have both PTSD and alcohol use disorder reduce their drinking and PTSD symptoms. **You may be eligible if:** - You are a US military veteran or active first responder (EMT, paramedic, firefighter, or police officer) - You are between 21 and 65 years old - You meet diagnostic criteria for both PTSD and alcohol use disorder - You want to reduce or stop drinking - You have a trusted person who can stay with you overnight after the treatment session - You live near the University of Washington and can attend multiple in-person visits - You have access to the internet and a computer or smartphone **You may NOT be eligible if:** - You have a history of seizures, serious heart disease, stroke, or severe asthma - You have a history of schizophrenia, schizoaffective disorder, or bipolar disorder - You had a serious suicide attempt in the past 12 months - You currently take antidepressants, antipsychotics, or mood stabilizers - You are currently in CBT, EMDR, or other evidence-based PTSD therapy - You have a history of hallucinogen use disorder or have abused psychedelics - You are pregnant, breastfeeding, or planning to become pregnant - You are enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPsilocybin 25 mg

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

DRUGMaltodextrin (Placebo)

25 mg of Maltodextrin (delivered in a capsule)


Locations(1)

University of Washington Center for Novel Therapeutics in Addiction Psychiatry

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06853912


Related Trials