Mental Disorder, PTSD, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Trauma and Stressor Related Disorders
Conditions
Keywords
psilocybin, psilocybin-assisted therapy, psychedelics, veterans
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.
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.
Interventions
DRUGPsilocybin
Participants will receive 15 mg of oral psilocybin in the first session and 25 mg in the second session.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy | Baseline to Primary Endpoint (1 month post psilocybin session 2) | The primary clinician/session facilitator for each participant will identify/record adverse effects (i.e. the emergence of any untoward physical or psychological events or symptoms) and safety concerns at each study visit. The type, severity, and frequency of adverse events will be collected in order to identify and characterize any safety concerns that may arise. Relationship to study drug will also be reported |
| Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline to Primary Endpoint (1 month post psilocybin session 2) | The C-SSRS is divided into four subscales based on 1) severity of ideation 2) intensity of ideation 3) suicidal behavior, and 4) lethality of attempt. Severity of ideation scores will be assessed for significant changes from baseline to primary endpoint. Proportion of participants meeting criteria for low, medium, and high risk will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5) | Baseline to Primary Endpoint (1 month post psilocybin session 2) | The CAPS-5 is a 30-item structured-interview that assesses PTSD diagnostic status and symptom severity. It is scored on a scale of 0-80 with higher scores indicating greater symptom severity. |
| PTSD Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5) | Baseline to Primary Endpoint (1 month post psilocybin session 2) | The PCL-5 is one of the most widely used self-report measures of PTSD with scores ranging from 0 to 80 and higher scores indicating greater PTSD symptom severity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlan K Davis, PhD
Ohio State University
Outcome results
None listed