Recruiting
Phase 2

Guided Psilocybin

Sponsor:

Baylor College of Medicine

Code:

NCT06888128

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Not accepted

Interventions

Psilocybin 15mg

Psilocybin 25mg

Study Details

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 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.

Conditions

PTSD

Study ID

NCT06888128

Start date

Jan 30, 2025

Status verified date

Jan, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psilocybin-assisted therapy

Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions.

Interventions

Psilocybin 15mg

Each participant will have a low dose (15 mg) psilocybin session to establish basic skills with session format, psilocybin effects, and continue to build rapport with session facilitators. Given the potential intensity of the psilocybin and the reality of experiencing significant trauma memories, the purpose of the first psilocybin session is to familiarize participants with the drug effects that may be encountered at a higher dose of psilocybin. The first psilocybin session will also allow for assessment of both the suitability of each participant to the study procedures and drug effects, and the safety of administering a higher dose to each participant.

Psilocybin 25mg

The second psilocybin session will utilize a high dose (25mg) and take place approximately 2 weeks after the first psilocybin session.

Primary outcome measure

  • Safety of psilocybin-assisted therapy for PTSD [ Time Frame: Baseline to 6-month follow up ]
  • Safety of psilocybin-assisted therapy for PTSD [ Time Frame: Baseline to 6-month follow up ]
  • Efficacy of psilocybin-assisted therapy for PTSD [ Time Frame: Baseline to 6-month follow up ]

Central Contacts and Locations

Central contacts

Lynnette A. Averill, Ph.D.

‪(832) 271-6615emerging@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Marika Del Motte, M.Sc.

713-798-3212marika.delmotte@bcm.edu

Principal Investigator:

Lynnette A. Averill, Ph.D.

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • PTSD
  • veterans
  • psilocybin
  • trauma
  • psychedelic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-01-22.