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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Nathan Brashares Sackett
Study ID
NCT06853912
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alcohol Use Disorder (AUD)
  • PTSD

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

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)
  • Maltodextrin (Placebo) — DRUG
    25 mg of Maltodextrin (delivered in a capsule)

Study Details

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 Dates

Start date
Jun 1, 2025
Status verified
Aug 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin + Nondirective Psychological Support
    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.
  • Placebo Comparator: Placebo + Nondirective Psychological Support
    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.

Primary Outcome Measure

Safety of Psi-PS [ Time Frame: Within approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Center for Novel Therapeutics in Addiction PsychiatrySeattleWashington98195
Christina Sargent, BS
[email protected]
206-685-1819
Nathan Sackett, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Washington Center for Novel Therapeutics in Addiction Psychiatry· Seattle, WA

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