Assessing the effects of psilocybin therapy on PTSD in veterans
The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
This study is testing whether psilocybin therapy can help U.S. military veterans with PTSD feel better and recover from their trauma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years to 64 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06888128 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and effectiveness of psilocybin-assisted therapy for treating PTSD in U.S. military veterans. Participants will undergo two sessions of psilocybin administration, combined with psychotherapy, to evaluate the long-term impact on their trauma recovery. The study aims to build on previous research by focusing on a specific veteran population and utilizing established therapeutic protocols. The trial will assess both the clinical efficacy and tolerability of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are U.S. military veterans diagnosed with PTSD who meet specific eligibility criteria.
Not a fit: Patients who are not veterans or those with a history of frequent hallucinogen use may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the mental health and quality of life for veterans suffering from PTSD.
How similar studies have performed: Previous studies on psilocybin-assisted therapy have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Lynnette A. Averill, Ph.D.
- Email: emerging@bcm.edu
- Phone: (832) 271-6615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.