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

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

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Drug: Psilocybin 15mg; Drug: Psilocybin 25mg

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lynnette A. Averill, Ph.D.; Phone Number: ‪(832) 271-6615; Email: emerging@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Marika Del Motte, M.Sc.; Phone Number: 713-798-3212; Email: marika.delmotte@bcm.edu
      • Principal Investigator: Lynnette A. Averill, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be a United States Military Veteran
• Have at least a high-school level of education or equivalent (e.g. GED).
• Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder
• Have a CAPS-5 total severity score of ≥23 at baseline
• SSRIs will be allowable so long as participants are on a stable regimen for a period of 3 months.
• Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study.
• Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
• No use of hallucinogens in the past 3 months and no history of regular or frequent use of hallucinogens

Exclusion Criteria:

• General medical exclusion criteria:

  • Individuals who are pregnant or nursing; individuals who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control
  • Individuals with partners of childbearing potential who are sexually active and not practicing a highly effective means of contraception
  • Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), prolonged QTc interval (i.e., QTc > 450 msec), artificial heart valve, or TIA in the past year • Systolic blood pressure (SBP) > 139 mm HG; diastolic blood pressure (DBP) > 89 mm HG; heart rate (HR) > 90 bpm.
  • Epilepsy with history of seizures
  • Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of symptoms of hypoglycemia

• Psychiatric Exclusion Criteria:

  • Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
  • Current or history within six months of meeting DSM-5 criteria for a moderate or severe alcohol, tobacco, caffeine, or other drug use disorder; if a regular smoker, they must agree to use a nicotine patch on the day of dosing as smoking will not be allowed on these sessions
  • Have a first degree relative with schizophrenia spectrum or other psychotic disorders including substance/medication-induced or due to another medical condition
  • Risk for acute suicidality as determined by clinician judgment (C-SSRS)
  • Has a psychiatric condition which precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, history of significant stress-related paranoia, and identity disturbances
  • History of a medically significant suicide attempt
  • Current MAOI antidepressant use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Psilocybin-assisted therapy; Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions.

Drug: Psilocybin 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.; Drug: Psilocybin 25mg; The second psilocybin session will utilize a high dose (25mg) and take place approximately 2 weeks after the first psilocybin session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of psilocybin-assisted therapy for PTSD	Safety as measured by Adverse Event Reporting	Baseline to 6-month follow up
Safety of psilocybin-assisted therapy for PTSD	Safety as measured by changes in suicidal ideation on the Columbia Suicide Safety Rating Scale (CSSRS). This section of the measure is assessed on a scale of 0 to 25, with higher scores indicating greater intensity of suicidal ideation.	Baseline to 6-month follow up
Efficacy of psilocybin-assisted therapy for PTSD	Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score. This measure is assessed on a scale of 0 to 80, with higher scores reflecting increased severity of PTSD symptoms.	Baseline to 6-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported clinical efficacy of psilocybin-assisted therapy for PTSD symptoms	Change in self-reported PTSD Checklist 5 (PCL-5) scores. This measure is assessed on a scale of 0 to 80, with higher scores reflecting increased severity of PTSD symptoms.	Baseline to 6-month follow up
Self-reported clinical efficacy of psilocybin-assisted therapy for depressive symptoms	Changes in self-reported Quick Inventory of Depression Severity (QIDS) scores. This measure is assessed on a scale of 0 to 27, with higher scores reflecting increased severity of depressive symptoms.	Baseline to 6-month follow up
Self-reported clinical efficacy of psilocybin-assisted therapy for anxiety symptoms	Changes in self-reported Generalized Anxiety Disorder-7 (GAD-7) scores. This measure is assessed on a scale of 0 to 21, with higher scores reflecting increased severity of anxiety symptoms.	Baseline to 6-month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Resting-State Functional Connectivity	The effect of psilocybin-assisted therapy on functional connectivity networks using resting-state functional magnetic resonance imaging (MRI)	Baseline to 6-month follow up

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Usona Institute; Texas Department of State Health Services; AIM Youth Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; trauma; veterans; psilocybin; psychedelic
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Stress Disorders, Post-Traumatic; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Indoles; Indole Alkaloids; Indolizidines; Indolizines; Tryptamines; Psilocybin
• Other Study ID Numbers: H-50300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No