State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
Recruiting
Phase 2Interventional Study
PTSD
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 64
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Baylor College of Medicine · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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 partic…
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
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