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Completed
NCT05554094
Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder
Conditions: PTSD, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorder
Sex: All
Ages: 21 Years – 64 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 12
Sponsor: Ohio State University
Location: Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center Columbus Ohio
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.
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
Source: ClinicalTrials.gov (NCT05554094). StuddyBuddy aggregates publicly available trial information.