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

NCT06853912 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00021194
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder (AUD); PTSD

Keywords

Psilocybin; Psychological Support; PTSD; AUD; Military Veterans and First Responders; Psychedelics; Vet; Veteran; Post-Traumatic Stress Disorder; Alcohol; Alcohol Use Disorder; Post Traumatic Stress Disorder; Military; Military Veterans; First Responders; Healthcare Workers

Outcome Measures

Primary Outcomes (1)

• Safety of Psi-PS

  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).

  Within approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS.

Secondary Outcomes (1)

• Subjective Experiences

  On the day of the DAS, 1-week post-DAS, and 3-months post-DAS

Other Outcomes (1)

• Changes in Alcohol Use and PTSD Symptom Severity, Suitability, and Acute Effects

  1-, 3-, and 6-months post-treatment between psilocybin and placebo groups

Study Arms (2)

Psilocybin + Nondirective Psychological Support

EXPERIMENTAL

The intervention is composed of two 60-minute telehealth preparation sessions (Prep 1 and Prep 2) with two facilitators; one 6-8-hour drug administration session (25 mg of oral psilocybin) in a clinical setting with the same two facilitators present; and three 60-minute telehealth integration sessions (Integration 1-3) with the same two facilitators. Ideally the entire intervention will be delivered over 6 weeks allowing for some flexibility based on schedules and logistics.

Drug: Psilocybin 25 mg

Placebo + Nondirective Psychological Support

PLACEBO COMPARATOR

The arm is composed of two 60-minute telehealth preparation sessions (Prep 1 and Prep 2) with two facilitators; inert placebo (25 mg of Maltodextrin) administered in a clinical setting with the same two facilitators present; and three 60-minute telehealth integration sessions (Integration 1-3) with the same two facilitators. Ideally the entire intervention will be delivered over 6 weeks allowing for some flexibility based on schedules and logistics.

Drug: Maltodextrin (Placebo)

Interventions

Psilocybin 25 mg DRUG

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

Also known as: PEX010, PYEX

Psilocybin + Nondirective Psychological Support

Maltodextrin (Placebo) DRUG

25 mg of Maltodextrin (delivered in a capsule)

Placebo + Nondirective Psychological Support

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Nathan Brashares Sackett: lead
• Washington State Legislation: collaborator

Study Sites (1)

University of Washington Center for Novel Therapeutics in Addiction Psychiatry

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Psilocybin; maltodextrin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Nathan B Sackett, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Sargent

CONTACT

206-543-5941; sargec2@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study team and participants will remain masked until 1-month post-Drug Administration Session follow-up data are collected from each participant. At the end of this visit, all parties will be unmasked and those revealed to have received placebo will be invited to participate in an open-label extension where they repeat two preparation sessions, the drug administration session, and three integration sessions (Visits 4-9) with psilocybin before moving into long-term follow-up at 12- and 24-weeks post-Drug Administration Session. If a participant in the placebo arm declines to participate in the Open-Label Extension, they will move into the 12- and 24-week post-Drug Administration Session follow-up visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Addiction Psychiatrist, Assistant Professor

Model Details: A single-site, double-blinded, placebo-controlled, randomized clinical trial with an open-label extension phase assessing safety in two conditions: (1) 25 mg of psilocybin combined with nondirective psychological support (Psi-PS); and (2) placebo and nondirective psychological support.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: March 3, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)