Status:
RECRUITING
State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Texas Department of State Health Services
Usona Institute
Conditions:
PTSD
Eligibility:
All Genders
21-64 years
Phase:
PHASE2
Brief 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 administratio...
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
- 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
Key Trial Info
Start Date :
January 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06888128
Start Date
January 30 2025
End Date
August 31 2025
Last Update
March 21 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030