Assessing the effects of psilocybin therapy on PTSD in veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.