Clinical TrialPTSDPsilocybinActive not recruiting

Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

Single-group Phase II study (n=15) testing two doses of oral psilocybin (15 mg then 25 mg, two sessions ~2 weeks apart) with preparatory and integration psychotherapy in US military Veterans with PTSD.

Target Enrollment
15 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This single-group, interventional Phase II study will enroll 15 US military Veterans with DSM-5 PTSD to evaluate safety and efficacy of psilocybin-assisted psychotherapy.

Participants receive preparatory therapy (up to 6–8 hours across up to 4 meetings), two psilocybin sessions (15 mg then 25 mg about two weeks apart; each session ≈8 hours, two facilitators), and post-session integration visits with follow-up to 6 months.

Study Protocol

Preparation

4 sessions
420 min each

Dosing

2 sessions
480 min each

Integration

2 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin-assisted therapy

experimental

Two-dose psilocybin with preparatory and integration therapy sessions (single-group design).

Interventions

  • Psilocybin15 - 25 mg
    via Oral• two sessions• 2 doses total

    15 mg first session; 25 mg second session; each session ~8 hours; facilitated by two trained session facilitators.

Participants

Ages
21 – 64
Sexes
Male & Female

Inclusion Criteria

  • A US military Veteran
  • 21 to 64 years old
  • Have at least a high-school level of education or equivalent.
  • Have a current DSM-5 diagnosis of Post-Traumatic Stress Disorder
  • Have a CAPS-5 total severity score of ≥35 at baseline
  • No antidepressant medications prior to enrollment
  • Be judged by study team clinicians to be at low risk for suicidality
  • Be medically stable
  • Have limited lifetime use of hallucinogens

Exclusion Criteria

  • General medical exclusion criteria:
  • Women who are pregnant
  • Cardiovascular conditions
  • Epilepsy with history of seizures
  • Insulin-dependent diabetes
  • Currently taking psychoactive prescription medication
  • Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including Monoamine oxidase inhibitors.
  • Psychiatric Exclusion Criteria:
  • Current or past history of schizophrenia or other psychotic disorders or Bipolar I or II Disorder
  • Current or history within one year of a moderate or severe alcohol, tobacco, or other drug use disorder
  • Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders or Bipolar I or II Disorder
  • Has a psychiatric condition which precludes the establishment of therapeutic rapport
  • History of a medically significant suicide attempt
  • Current antidepressant use

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment15 participants
  • Timeline
    Start: 2023-01-01
    End: 2025-01-31
  • Compound
    Psilocybin
  • Topic
    PTSD

Locations

Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center — Columbus, Ohio, United States

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