Active, Not RecruitingPhase 2psilocybin

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

Sponsored by Ohio State University

NCT ID
NCT05554094
Target Enrollment
15 participants
Start Date
2023-01-01
Est. Completion
2025-12-31

About This Study

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 Studied

PTSDStress Disorders, TraumaticStress Disorders, Post-TraumaticTrauma and Stressor Related DisordersMental Disorder

Interventions

  • Psilocybin

Eligibility

Age:21 Years - 64 Years
Healthy Volunteers:No
View full eligibility 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..

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 Locations (1)

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

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

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