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RecruitingPhase 2

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

NCT06888128 · STARLIGHT · Baylor College of Medicine

Recruiting
Status
Accepting participants
Phase 2
Phase
15
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Safety of psilocybin-assisted therapy for PTSD

    Measured over Baseline to 6-month follow up

  • Safety of psilocybin-assisted therapy for PTSD

    Measured over Baseline to 6-month follow up

  • Efficacy of psilocybin-assisted therapy for PTSD

    Measured over Baseline to 6-month follow up

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Baylor College of MedicineHoustonTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06888128 on ClinicalTrials.gov →

Last updated in the registry 2026-01-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits