Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co… (NCT06853912) | Clinical Trial Compass
RecruitingPhase 2
Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
United States40 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
What they're measuring
1
Safety of Psi-PS
Timeframe: Within approximately 24 hours post-DAS, i.e., when the drug's acute effects have subsided, and approximately one-week post-DAS.
. A reported history of known medical conditions that would preclude safe participation in the trial, including the following:
✕. Clinical findings on screening, including:
✕. 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.