Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder
The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans.
Conditions:
🦠 PTSD 🦠 Stress Disorders, Traumatic 🦠 Stress Disorders, Post-Traumatic 🦠 Trauma and Stressor Related Disorders 🦠 Mental Disorder
🗓️ Study Start (Actual) 1 January 2023
🗓️ Primary Completion (Estimated) 31 January 2025
✅ Study Completion (Estimated) 31 July 2025
👥 Enrollment (Estimated) 15
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Columbus, Ohio, United States

📋 Eligibility Criteria

Description

  • In order to be eligible to participate in this study, an individual must meet all of the following 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:

  • * 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..
  • * 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
Ages Eligible for Study: 21 Years to 64 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 September 2022
  • First Submitted that Met QC Criteria 21 September 2022
  • First Posted 26 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified May 2024