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Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD

NCT06902974 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-15

No results posted yet for this study

Summary

A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).

Conditions

  • Post Traumatic Stress Disorder
  • PTSD

Interventions

DRUG

Psilocybin 25 mg

Single dose, 25mg psilocybin, encapsulated, oral administration

Sponsors & Collaborators

  • Sunstone Medical

    lead OTHER

Principal Investigators

  • Manish Agrawal, MD, MSC · Sunstone Medical, PC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-11-30
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902974 on ClinicalTrials.gov