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State-Funded Trial of Guided Psilocybin for PTSD in US Veterans

This study is testing if psilocybin, combined with therapy, can safely and effectively treat Post-traumatic Stress Disorder (PTSD) in US Veterans. You would receive two sessions of psilocybin (15mg then 25mg) along with psychotherapy. Researchers will measure how safe the treatment is and if it helps reduce your PTSD symptoms over six months. To join, you must be a US Military Veteran between 21 and 64 years old, have a high school education, and a current diagnosis of PTSD. The study is currently unclear on its recruitment status and plans to enroll 15 participants.

Study design
This is an open-label study, meaning you and the researchers will know what treatment you are receiving. It plans to enroll 15 participants.
What's involved
You would participate in two psilocybin sessions approximately two weeks apart, combined with psychotherapy. Your safety and PTSD symptoms will be monitored for six months after the treatment.
Compensation
Not stated in the trial record.
Follow-up
Your safety and the effectiveness of the treatment will be measured from the start of the study up to six months after the treatment.

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NCT06888128

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

Recruiting
PHASE2Ages 21–64InterventionalTreatment
Baylor College of Medicine
~15 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Psilocybin 15mgPsilocybin 25mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of psilocybin-assisted therapy for PTSD
Measured over Baseline to 6-month follow up
+2 more outcomes measured

Conditions

PTSD

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Lynnette A. Averill, Ph.D.
[email protected]
‪(832) 271-6615
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • Safety of psilocybin-assisted therapy for PTSDBaseline to 6-month follow up

    Safety as measured by Adverse Event Reporting

  • Safety of psilocybin-assisted therapy for PTSDBaseline to 6-month follow up

    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.

  • Efficacy of psilocybin-assisted therapy for PTSDBaseline to 6-month follow up

    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.