NCT06888128PHASE2Recruiting
State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
Baylor College of Medicine
Start Date
1/30/2025
Completion Date
12/15/2026
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 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.
Eligibility Criteria
Age Range: 21 years to 64 years
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
Interventions
DRUG
Psilocybin 15mg
DRUG
Psilocybin 25mg
Conditions
PTSD
Locations
Baylor College of Medicine
Houston, Texas 77030
United States