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

• Status: Not yet recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Psilocybin

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