Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD (SUN004)

NOT YET OPEN FOR RECRUITMENT

A Sunstone Therapies IIT (Investigator Initiated Study)

Sunstone is recruiting participants for a phase 2, open-label study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Post-traumatic Stress Disorder (PTSD). 

Introduction and Rationale for Study

Sexual assault is a common form of trauma exposure globally and can have widespread detrimental effects to psychological, behavioral, physical health and well-being. Sexual violence appears to have a more substantial impact on mental health and well-being than other forms of trauma exposure. The disturbingly high rate of long-term PTSD in sexual assault survivors is a strong indication that the current therapies for this population are inadequate and in need of improvement.

Psilocybin, a naturally occurring psychoactive compound found in certain mushroom species, has shown promise as a therapeutic tool for various  difficult-to-treat mental health conditions. When administered in conjunction with trauma-informed psychological support, including preparation and post-administration integration sessions, psilocybin may catalyze new capacities for change in perspective, facilitate self-discovery, and promote emotional breakthrough.

Psilocybin may offer specific therapeutic benefits for survivors of sexual violence with PTSD.

Purpose and Description

To assess the safety and tolerability of psilocybin-assisted therapy in women with PTSD secondary to sexual assault.

Study participation will include but is not limited to the following study visits over the course of approximately 8 weeks:

  • Screening Period
  • Three (3) Preparatory Sessions
  • One (1) Dosing Session
  • Three (3) Integration Sessions
  • Up to 12 monthly group Integration Sessions after the 8 week period

Important Considerations

  • The study’s procedures and therapy are at no cost to the participant. 
  • Eligible participants will receive 25mg of psilocybin. All study participants will receive active study drug. 
  • Psilocybin will be administered with support from two specially trained and experienced mental-health practitioners in private rooms specifically designed for psychedelic therapy. Physicians and medical staff are present on site. 
  • The support includes careful preparation before the experience and processing after the experience with a therapist. Psychedelic effects are typically temporary, and safety is continually monitored.
  • Participants may remain on SSRIs if they have been on a stable dose for at least 3 months prior to enrollment  and do not plan to change their dosage until the end of the study. Participants MUST NOT change or discontinue ANY medication without the physician’s approval. If necessary, the study physician will consult with patients’ providers.
  • Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial. 
  • Risks to participation will be reviewed extensively during the screening and informed consent process.
  • All in-person study visits take place at Sunstone Therapies. 

To express interest in this upcoming study, click here:

Register Your Interest

For more information about this study on ClinicalTrials.gov, click here:

ClinicalTrials.gov Study Listing