Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder
(SUN004 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The proposed Phase 2, single-center, fixed dose, open-label study will explore the efficacy, safety, and tolerability of 25 mg dose of oral psilocybin in conjunction with therapy in cisgender women participants diagnosed with PTSD secondary to an index trauma of sexual assault.
Will I have to stop taking my current medications?
The trial allows participants to continue taking SSRIs if they have been on a stable dose for at least 3 months. However, participants must stop taking monoamine oxidase inhibitors (MAOIs) before starting the trial. The protocol does not specify other medication restrictions, so it's best to discuss your specific medications with the trial team.
Is psilocybin-assisted therapy generally safe for humans?
Psilocybin-assisted therapy appears to be generally safe when administered under supervision, with most side effects being mild and temporary. However, there are rare cases of severe adverse events, such as increased suicidal thoughts, and some individuals may experience challenging psychological experiences, especially without proper support.12345
How is psilocybin-assisted therapy different from other PTSD treatments?
Psilocybin-assisted therapy is unique because it involves the use of a psychedelic compound, psilocybin, which is administered in controlled doses under medical supervision to help patients confront traumatic memories and reduce emotional avoidance. Unlike traditional PTSD treatments, which often have limited efficacy and are difficult to tolerate, psilocybin may promote neuroplasticity (the brain's ability to change and adapt) and has shown promise in producing long-term improvements after just one or a few sessions.12678
What data supports the effectiveness of the drug psilocybin for treating PTSD?
Research suggests that psilocybin-assisted therapy may help reduce PTSD symptoms by decreasing emotional avoidance and increasing acceptance and self-compassion. Although no studies have directly tested psilocybin for PTSD, it has shown promise in treating related conditions like depression and anxiety, and early evidence indicates it may help with PTSD symptoms in combat veterans.12679
Who Is on the Research Team?
Manish Agrawal, MD, MSC
Principal Investigator
Sunstone Medical, PC
Are You a Good Fit for This Trial?
This trial is for cisgender women over 18 with PTSD from sexual assault. They must be able to swallow pills, have a negative pregnancy test if applicable, and agree to lifestyle changes and study procedures. Exclusions include serious risks to others, certain psychiatric disorders or treatments, uncontrolled health conditions, drug abuse, and men.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 25 mg dose of oral psilocybin in conjunction with therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunstone Medical
Lead Sponsor