Phase 2 PTSD Trial, Recruiting NCT06888128 Sponsor: Baylor College of Medicine Condition: PTSD
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Phase 2 PTSD Trial, Recruiting

NCT06888128
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are United States Military Veterans
  • People who have completed at least a high school education or the equivalent (such as a GED)
  • People who have a current diagnosis of Post-Traumatic Stress Disorder (PTSD) according to standard diagnostic criteria (DSM-5)
  • People whose PTSD symptoms score at or above a certain level on a standard clinical assessment at the start of the trial (confirm with trial site)
  • People who are taking SSRI antidepressants, provided the dose has been stable for at least 3 months
  • People currently attending talk therapy, provided the type and how often they attend has been stable for at least 2 months before screening and is expected to stay the same throughout the trial
  • People who are found to be in generally good physical health based on an interview, medical questionnaire, physical examination, heart tracing (ECG), and routine blood and urine tests
  • People who have not used hallucinogenic substances in the past 3 months and have no history of regular or frequent hallucinogen use

Who may not be able to join:

  • People who are pregnant, breastfeeding, or are capable of becoming pregnant and are sexually active without using a highly effective form of contraception
  • People whose partner is capable of becoming pregnant and who are sexually active without using a highly effective form of contraception
  • People with certain heart or blood vessel conditions, such as coronary artery disease, stroke, chest pain (angina), uncontrolled high blood pressure, certain abnormal heart rhythms, a prolonged interval on a heart tracing (ECG), an artificial heart valve, or a mini-stroke (TIA) in the past year
  • People whose blood pressure or resting heart rate is above certain levels at screening (confirm with trial site)
  • People with epilepsy or a history of seizures
  • People with insulin-dependent diabetes, or people taking oral diabetes medication who have experienced symptoms of low blood sugar
  • People with a current or past diagnosis of schizophrenia, other psychotic disorders (with some exceptions — confirm with trial site), or Bipolar I or II Disorder
  • People who have had a moderate or severe alcohol, tobacco, caffeine, or other substance use disorder in the past six months — note that regular smokers would need to agree to use a nicotine patch on dosing days, as smoking would not be permitted during those sessions
  • People who have a parent, sibling, or child with schizophrenia or a related psychotic disorder
  • People assessed by a clinician as being at immediate risk of suicide
  • People whose psychiatric condition makes it difficult to build a trusting therapeutic relationship, such as those with long-term patterns of unstable relationships, significant stress-related paranoia, or identity disturbances
  • People with a history of a medically serious suicide attempt
  • People currently taking MAOI antidepressant medications

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: ‪(832) 271-6615

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
30 January 2025
Est. completion
15 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety of psilocybin-assisted therapy for PTSD; Safety of psilocybin-assisted therapy for PTSD; Efficacy of psilocybin-assisted therapy for PTSD

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov