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

This open-label, Phase II trial (n=15) will investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of post-traumatic stress disorder (PTSD) in US military veterans. Participants will receive two psilocybin doses—15 mg in the first session and 25 mg in the second session—alongside psychotherapy.

The study, known as the STARLIGHT trial, is conducted by Baylor College of Medicine and is funded by the Texas Department of State Health Services in collaboration with the Usona Institute and AIM Youth Mental Health.

The trial involves a five-week participation phase, including three preparatory therapy sessions, two psilocybin dosing sessions, and four integration therapy sessions. The first psilocybin session (15mg) aims to familiarise participants with the drug’s effects and assess their response before the higher dose (25mg) is administered approximately two weeks later. The primary outcomes include assessing the safety of psilocybin through adverse event reporting and changes in suicidal ideation, while the efficacy of treatment will be measured using PTSD symptom scales such as the Clinician-Administered PTSD Scale (CAPS-5). Additional measures will evaluate depression and anxiety symptoms, as well as neurobiological changes through MRI scans. The estimated study completion date is August 2025.

Topic PTSD Safety
Compound Psilocybin
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 30 January 2025
End date 31 August 2025
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 15
Sex All
Age 21- 64
Therapy Yes

Trial Details

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.

Trial Number NCT06888128

Sponsors & Collaborators

Baylor College of Medicine
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Data attribution

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