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NCT05554094 | Recruiting | PTSD

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

Ohio State University

Information provided by (Responsible Party):

Alan K. Davis

Brief Summary:

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.

Condition or disease

PTSD

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Trauma and Stressor Related Disorders

Mental Disorder

Intervention/treatment

Psilocybin

Phase

Phase 2

Detailed Description:

The objective of this study is to determine the safety and efficacy of psilocybin assisted psychotherapy in the treatment of Veterans with PTSD. This study will recruit 15 United States Military Veterans, age 21 to 64, primarily from the Columbus and Central Ohio Region who meet the criteria for PTSD. After enrollment and informed consent, participants will receive two separate doses of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. Each psilocybin session will last approximately 8 hours and will be facilitated by two trained session facilitators. Before the first psilocybin session, participants will meet with one or both of the session facilitators for a total of 6-8 hours of contact time (or up to 4 meetings) before the first psilocybin session day. Two post psilocybin therapy session visits will follow Psilocybin Sessions 1 and 2. Psilocybin Sessions 1 and 2 will occur about two weeks apart. Follow-up visits will occur 1 and 2 weeks and 1, 3, and 6 months after the final psilocybin session, with additional contact hours scheduled as needed. Thus, the intervention and follow-up requires at least 13 visits over a period of about 8-10 months.}}

Study Type : Interventional
Estimated Enrollment : 15 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : July 31, 2025
Arm Intervention/treatment

Experimental: Psilocybin-assisted therapy

Participants will receive two doses of psilocybin, approximately 2 weeks apart, in conjunction with preparatory and post-psilocybin therapy sessions

Drug: Psilocybin
Ages Eligible for Study: 21 Years to 64 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
  • 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..
    • More than 25% outside the upper or lower range of ideal body weight
    • 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
Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Ohio

Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center

Columbus, Ohio, United States, 43210