PTSD
Conditions
Keywords
PTSD, veterans, psilocybin, trauma, psychedelic
Brief summary
The principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of PTSD in US Veterans.
Interventions
DRUGPsilocybin 15mg
Each participant will have a low dose (15 mg) psilocybin session to establish basic skills with session format, psilocybin effects, and continue to build rapport with session facilitators. Given the potential intensity of the psilocybin and the reality of experiencing significant trauma memories, the purpose of the first psilocybin session is to familiarize participants with the drug effects that may be encountered at a higher dose of psilocybin. The first psilocybin session will also allow for assessment of both the suitability of each participant to the study procedures and drug effects, and the safety of administering a higher dose to each participant.
DRUGPsilocybin 25mg
The second psilocybin session will utilize a high dose (25mg) and take place approximately 2 weeks after the first psilocybin session.
Sponsors
Baylor College of Medicine
Texas Department of State Health Services
Usona Institute
AIM Youth Mental Health
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
* Be a United States Military Veteran * Have at least a high-school level of education or equivalent (e.g. GED). * Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder * Have a CAPS-5 total severity score of ≥23 at baseline * SSRIs will be allowable so long as participants are on a stable regimen for a period of 3 months. * Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study. * Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests * No use of hallucinogens in the past 3 months and no history of regular or frequent use of hallucinogens
Exclusion criteria
* General medical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of psilocybin-assisted therapy for PTSD | Baseline to 6-month follow up | Safety as measured by Adverse Event Reporting |
| Efficacy of psilocybin-assisted therapy for PTSD | Baseline to 6-month follow up | Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score. This measure is assessed on a scale of 0 to 80, with higher scores reflecting increased severity of PTSD symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms | Baseline to 6-month follow up | Change in self-reported PTSD Checklist 5 (PCL-5) scores. This measure is assessed on a scale of 0 to 80, with higher scores reflecting increased severity of PTSD symptoms. |
| Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms | Baseline to 6-month follow up | Changes in self-reported Quick Inventory of Depression Severity (QIDS) scores. This measure is assessed on a scale of 0 to 27, with higher scores reflecting increased severity of depressive symptoms. |
| Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms | Baseline to 6-month follow up | Changes in self-reported Generalized Anxiety Disorder-7 (GAD-7) scores. This measure is assessed on a scale of 0 to 21, with higher scores reflecting increased severity of anxiety symptoms. |
Countries
United States
Contacts
CONTACTLynnette A. Averill, Ph.D.
Outcome results
None listed