RecruitingPhase 2NCT06888128

State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma

The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma

Sponsor

Baylor College of Medicine

Enrollment

15 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

PTSD

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.

Eligibility

Min Age: 21 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether psilocybin (the active compound in "magic mushrooms"), combined with guided therapy sessions, can help U.S. military veterans heal from post-traumatic stress disorder (PTSD). It is a state-funded trial assessing both safety and recovery. **You may be eligible if...** - You are a United States military veteran - You have a current PTSD diagnosis based on official criteria - Your PTSD symptoms score 23 or higher on a clinical assessment (CAPS-5) - You have at least a high school diploma or GED - If you take SSRIs (antidepressants), you have been on a stable dose for at least 3 months **You may NOT be eligible if...** - You have a personal or family history of psychosis or certain other psychiatric conditions - You are currently in unstable mental health crisis - You are pregnant or breastfeeding - You have significant heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Baylor College of Medicine

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06888128

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