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

State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma (NCT06888128) is a Phase 2 interventional studying PTSD, sponsored by Baylor College of Medicine. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against PTSD and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 15 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - General medical Who Should NOT Join This Trial: - 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 Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Baylor College of Medicine

Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06888128), the sponsor (Baylor College of Medicine), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06888128 clinical trial studying?

Who can participate in NCT06888128?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06888128?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06888128. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06888128. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.