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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PTSD Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psilocybin-assisted therapy

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

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

Participants will receive 15 mg of oral psilocybin in the first session and 25 mg in the second session.

Interventions

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Psilocybin

Participants will receive 15 mg of oral psilocybin in the first session and 25 mg in the second session.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No