Psilocybin for Post-Traumatic Stress Disorder
(STARLIGHT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial allows participants to continue taking SSRIs (a type of antidepressant) if they have been on a stable dose for at least 3 months. However, if you are currently using MAOI antidepressants, you will need to stop taking them to participate in the trial.
What data supports the effectiveness of the drug psilocybin for treating PTSD?
Research suggests that psilocybin, a psychedelic drug, may help reduce PTSD symptoms by promoting positive psychological changes and helping people confront traumatic memories. Although it hasn't been specifically tested for PTSD, studies show it can improve mood and anxiety in other conditions, and early evidence indicates it might help combat veterans with PTSD.12345
Is psilocybin safe for humans?
Psilocybin is generally considered safe when given in a controlled setting with proper support, although some people may experience challenging psychological effects. In a survey, a small percentage of people reported risky behavior or needed medical help after taking psilocybin, but most participants found the experience beneficial.14567
How is the drug psilocybin different from other PTSD treatments?
Psilocybin is unique because it is a psychedelic drug that may help with PTSD by promoting neuroplasticity (the brain's ability to change and adapt) and facilitating fear extinction, which is important for overcoming traumatic memories. Unlike traditional treatments, psilocybin is used in combination with psychotherapy and is being explored as a novel approach due to its potential to address symptoms that other treatments struggle with.14589
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for US Military Veterans with PTSD who have a high school education or equivalent, are on stable SSRIs if applicable, and haven't used hallucinogens recently. They must be medically stable without severe substance use disorders, no major psychiatric conditions like schizophrenia or bipolar disorder, not at risk of suicide, and agree to contraception if needed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 5-week participation phase including 3 preparatory sessions, 2 psilocybin dosing days, and 4 integration sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
AIM Youth Mental Health
Collaborator
Texas Department of State Health Services
Collaborator
Usona Institute
Collaborator