Actively Recruiting
State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
Led by Baylor College of Medicine · Updated on 2026-01-22
15
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
Texas Department of State Health Services
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Be on a stable regimen of SSRIs for at least 3 months
- If receiving psychotherapy, have stable type and frequency for at least 2 months prior to screening and expected stability during study
- Be medically stable as determined by personal interview, questionnaire, physical exam, ECG, and routine blood and urinalysis tests
- No use of hallucinogens in the past 3 months and no history of regular or frequent hallucinogen use
You will not qualify if you...
- Pregnant or nursing individuals, or those of child-bearing potential not practicing highly effective birth control
- Individuals with partners of childbearing potential who are sexually active and not using effective contraception
- Cardiovascular conditions including coronary artery disease, stroke, angina, uncontrolled hypertension, significant ECG abnormalities, prolonged QTc interval, artificial heart valve, or TIA in past year
- Systolic blood pressure over 139 mm Hg, diastolic blood pressure over 89 mm Hg, or heart rate over 90 bpm
- History of epilepsy with seizures
- Insulin-dependent diabetes or symptomatic hypoglycemia if on oral hypoglycemics
- Current or past schizophrenia spectrum or other psychotic disorders, or Bipolar I or II Disorder
- Moderate or severe substance use disorder in past 6 months, including alcohol, tobacco, caffeine, or other drugs
- Regular smokers must agree to use nicotine patch on dosing day
- First degree relative with schizophrenia or other psychotic disorders
- Risk for acute suicidality as judged clinically
- Psychiatric conditions preventing therapeutic rapport, including unstable relationships, paranoia, or identity disturbances
- History of medically significant suicide attempt
- Current use of MAOI antidepressants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Lynnette A. Averill, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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